Assessment of the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
Phase: NA
Conditions: Complications Associated With Device
Sponsor: B. Braun Medical Inc.

DI 
AUN 
S 
RI NG E P 
IS 
B. Braun Medical Inc. 
FINAL, CLINICAL STUDY PROTOCOL 
Protocol Number: US-N-H-1801 
Amendment 1 
Assessment of the Effect of B. Braun Peripheral Advantage Program on 
Complications, Indwell Time and First Stick Success of PIVC Therapy 
Name of Products: 
Device Classification: 
Phase of Development: 
Study Indication: 
Sponsor Contact: 
Protocol Version: 
Protocol Date: 
Peripheral Advantage Program 
Christie Vein Viewer® Vision2 
Introcan Safety® IV Catheters - II 
STEADYCare™ Smallbore Extension Set 
with Wedge™ Catheter Stabilizer- II 
4 (post-marketing study) 
NA 
Christopher R. Curtin 
Manager Clinical Development, Medical 
Affairs 
B. Braun Medical Inc. 
901 Marcon Blvd. 
Allentown, PA 18109 
Tel: 
+ 1 610-596-2726 
e-mail: chris.curtin@bbraunusa.com 
2.0 Final 
03 February 2021 
-CONFIDENTIAL-
This document and its contents are the property of and confidential to B. Braun Medical 
Inc. Any unauthorized copying or use of this document is prohibited. 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
SPONSOR APPROVAL PAGE 
Product name: 
Peripheral Advantage Program 
B. Braun protocol number: 
US-N-H-1801 
h!e.r Cet11anw:rkl ;f1J) 
Wes Cetnarowski MD (Feb 5, 202110:44 PST) 
Wes Cetnarowski, MD 
Senior Vice President, Scientific Affairs 
and Chief Medical Officer 
~
M Kar~
Ml? 
~
Karpf, MD(Feb ~
113:48 EST) 
Angela Karpf, MD 
Corporate Vice President, Scientific Affairs 
Rebecca Sfo!aricf-. 
Rebecca Stoia rick (Feb 5, 2021 18:09 EST) 
Rebecca Stolarick 
Corporate Vice President, Regulatory Affairs 
Diana Va lencia (Feb 5, 202113:28 EST) 
Diana Valencia, MD 
Director, Medical Affairs 
Chnrtcwher X: Cutti11 
Christopher R/curtin (Feb 5, 2021 13:18 EST) 
Christopher R. Curtin 
Manager Clinical Development, Medical 
Affairs 
03 February 2021 
Date: 
Date: 
Date: 
Date: 
Date: 
US-N-H-1801 
Final Protocol Amendment 1 
Feb 5, 2021 
Feb 5, 2021 
Feb 5, 2021 
Feb 5, 2021 
Feb 5, 2021 
Page 2 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
INVESTIGATOR PROTOCOL AGREEMENT PAGE 
Product name: 
B. Braun protocol number: 
I agree: 
Peripheral Advantage Program 
US-N-H-1801 Amendment 1 
• 
To assume responsibility for the proper conduct of the study at this site. 
• 
To conduct the study in compliance with this protocol, any future amendments, and 
with any other study conduct procedures provided by B. Braun Medical Inc. 
• 
Not to implement any changes to the protocol without written agreement from 
B. Braun Medical and prior review and written approval from the Institutional 
Review Board (IRB) except where necessary to eliminate an immediate hazard to 
patients. 
• 
That I am thoroughly familiar with the appropriate use of the study devices, as 
described in this protocol and any other information provided by B. Braun Medical. 
• 
That I am aware of, and will comply with, good clinical practices (GCP) and all 
applicable regulatory requirements. 
• 
To ensure that all persons assisting me with the study are adequately informed about 
the B. Braun Medical study devices and of their study-related duties and functions as 
described in the protocol. 
Signature: 
Name 
(print): 
03 February 2021 
Date: 
Principal Investigator 
Page 3 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Name: 
Diana Valencia, MD 
Director, Medical Affairs - Study 
Safety Physician 
Christopher R. Curtin 
Manager Clinical Development, 
Medical Affairs 
03 February 2021 
US-N-H-1801 
Final Protocol Amendment 1 
CONTACT LIST 
B. Braun Medical Inc. 
901 Marcon Blvd. 
Allentown, PA 18109 
B. Braun Medical Inc. 
901 Marcon Blvd. 
Allentown, PA 18109 
Telephone: + 1 610-596-2875 
Email: diana. valencia(a),b braunusa. com 
B. Braun Medical Inc. 
901 Marcon Blvd. 
Allentown, PA 18109 
Telephone: + 1 610-596-2726 
Email: chris.curtin(a),bbraunusa.com 
Page 4 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
PROTOCOL AMENDMENTS 
Original Protocol issued 11 July 2019 
Amendments are listed beginning with the most recent amendment. 
US-N-H-1801 
Final Protocol Amendment 1 
In this summary document new text is bolded and underlined where as the deleted text is 
strbtck through for easy identification. 
Amendment 1: 03 February 2021 
Amendment 1: List of Changes 
The overall reason for the amendment: The overall reason for this substantial amendment is to allow multiple 
study sites, to allow for enrollment from the Emergency Department, to allow for consenting by subject's 
Legally Authorized Representative (LAR), to clarify text regarding the definitions of a Study Completer and to 
clarify text regarding re-enrollment. 
Applicable Section(s) 
Text Changes 
(new text in bold/underlined, deleted text in 
st:rikeottt) 
Description of change I 
Rationale for Change 
Throughout the document, minor typographical errors, misspellings and minor formatting issues have been 
resolved. These minor changes are not listed in this summary. 
Sponsor Approval 
Angela Karpf, MD 
Added new approver 
Synopsis: 
Investigators/Study 
Sites 
Synopsis: Study 
Design 
03 February 2021 
Corporate Vice President, Scientific Affairs 
A si±l:gle A multi-center study to include 
individual hospitali or multiple hospital locations 
within a single hospital network. 
The study will be conducted in the Emergency 
Department (ED) and/or Mmedical Ssurgical 
(MS) floor(s)/unit(s) efin multiple hospitals the 
hospital/hospital aetwork. 
Other B. Braun personnel 
contact and/or Title 
information was updated. 
Clarification of the number 
of hospitals allowed to 
participate in the study. 
Clarification of the number 
of hospitals allowed to 
participate in the study. 
Page 5 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Synopsis: Study 
Population 
Registered Nurses: RNs from the ED or MS 
unit(s)/department(s) of the hospital/hosf)ital 
can be on any shift and will not be required to 
have a minimum level of clinical experience. Any RNs 
from the participating floors or the hospital ED are 
eligible to participate in Stage 1 of the study, After 
completion of protocol training and any required site 
specific training (GCP, consent process, etc.), they are 
considered a Study RN. 
All RNs withiH the llflit may CO!Hfllete the B. Bi=auH 
f)f0tocol FeEfUirea traifliHgs. Those Study RNs who have 
not completed all of the required training in the 
B. Braun Peripheral Advantage Program 
rnquirea ti=aiHiHg in Stage 2 cannot continue on to 
Stages 3 and 4 and thus will be removed from 
participation in the study. Stuay IU>+s shoula Hot be 
currnHtly usiHg the The B. Braun Introcan Safety® IV 
Catheters 
and/or 
the 
STEADYCare™ 
Smallbore 
Extension Set utilized in this study cannot currently be 
in use in any of the participating units/departments at 
the time of initiating the study. 
The sites participating in the study cannot be 
currently using the +he B. Braun Introcan Safety® IV 
Catheters or aH4er the STEADYCare™ Smallbore 
Extension Set or the Christie Vein Viewer utilized in this 
study cannot curreHtly be usea in any of the participating 
units/departments at the time of initiating the study. 
Subjects: Subjects or his/her Legally Authorized 
Representative (if appropriate) will be consented by 
US-N-H-1 801 
Final Protocol Amendment 1 
Updated to allow for 
emollment from the 
Emergency Department 
Study RNs before participating in Stage 1 and/or Stage 4 
Allowing for LARs. 
Synopsis: Selection of 
Patients: Inclusion 
Criteria 
Section 4.1: Inclusion 
Criteria 
Synopsis: Selection of 
Patients: Exclusion 
Criteria 
Section 4.2: Exclusion 
Criteria 
Synopsis: Planned 
Sample Size 
Synopsis: 
Components of the B. 
Braun Peripheral 
Advantage Program 
03 February 2021 
Inclusion Criteria #2: The subject or the subject's 
LAR voluntarily agrees that the subject will 
participate in this study and is able Ahle to 
understand and sign the Informed Consent Form 
(ICF); 
Inclusion Criteria #3: Have a medical condition that 
requires a PIVC anticipated to lastiag for at least 
48 hours 
Exclusion Criteria #3: The subject or his/her LAR 
~Are an employee of the Investigator or study 
center or the sponsor ......... . 
Exclusion Criteria #5: 5. Patient has an existing 
non study related IV. in one arm and has a medical 
condition prohibiting contralateral PIVC insertion. 
The number of PIVC insertion attempts will be 
recorded. 
The devices in the B. Braun PA Program are all 
cleared for marketing or exempt from clearance 
by the FDA. There will be no study specific 
product labels 
Allowing for LARs 
Clarification of the 
requirements for the 
48 hour PIVC duration to be 
"anticipated". 
Allowing for LARs. 
Clarifying to record PIVC 
insertion attempts 
Indicating all B. Braun 
products are FDA approved 
or exempted. 
Page 6 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Synopsis: Criteria for 
Evaluation 
Synopsis: Study 
Endpoints 
Stage 1: Any RNs from the participating floors or 
the hospital ED are eligible to participate in 
Stage 1 of the study. After completion of protocol 
training and any required site specific training 
(GCP, consent process, etc.), they are considered 
a Study RN . ...... Subjects or their LAR (if 
appropriate) will be consented provide consent 
and they must meet all inclusion and none of the 
exclusion criteria prior to the RN performing a 
study related PIVC procedure and collection of data. 
Stage 2: The Intervention Stage will be conducted 
after the completion of the Baseline Stage. Note: 
an RN may join the study in Stage 2 provided 
they have completed the site's required research 
training and protocol specific training before 
participating in Stage 2. All participating Study 
RNs from the medical surgical ooit(s) of the 
hospital/hospital network may take part in this 
Stage for education and skill assessment/perception 
to assess the change in their confidence and 
knowledge with-after learning .......... 
Stage 3: Only&ttay RNs who have completed 
Stage 2 may participate in this Stage of the study 
and will be considered a Study RN. 
Stage 4: Subjects or his/her LAR (if appropriate) 
will be consented provide consent and they must 
meet all inclusion and none of the exclusion criteria 
The primary endpoint for this study is the 
rate/percentage of catheter removals due to 
complications ... .. 
•Indwell time for catheters with and withottt 
complications (measured in hours) 
US-N-H-1801 
Final Protocol Amendment 1 
Updated to allow for 
emollment from the 
Emergency Department and 
allowing for LARs. 
Indicating a new RN can 
join in Stage 2. 
Indicating an RN must 
complete stage 2 to go to 
Stage 3. 
Allowing for LARs. 
Clarifying Primary 
Endpoint is the overall 
rate/percentage of 
complications. 
Synopsis: Safety 
Analyses 
Events may include, but are not limited to: minor 
Minor text changes. 
and major complications such as, infection or, 
thrombttS ophlebitis, ,--ana device failures (i.e., 
disconnection, twisted port hub, leakage, and failure 
of the safety feature) and needlestick injuries. 
03 February 2021 
Page 7 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Section 3 .1: Study 
Design 
Section 3 .2.1: 
Registered Nurses 
Section 3.2.2: 
Subjects 
The study will be conducted in the medical surgical 
tloof department(s)/unit(s) of multiple hospitals 
the hospital/hospital network. Patients from the 
Emergency Department (ED) are also eligible to 
be enrolled. All Any RNs from these floors or the 
hospital ED ffifl3/ are eligible to participate in Stage 
l_and Stage 2_ofthe study. After completion of 
protocol training and any required site specific 
training (GCP. consent process. etc.) the RNs will 
be considered Study RNs. The Study RNs from 
Stage 1 and any other RNs from the medical 
surgical floor(s)/unit(s) or the hospital ED who 
complete protocol training may participate in the 
intervention (Stage 2). A core grottp of ID-rs (The 
Study 
on all shifts who have completed the 
protocol training/intervention (Stage 2) will 
participate in Stage 3 and Stage 4 of the study. 
+hese All Study RNs will be responsible for PIVC 
insertions and_monitoring catheter examinations. 
Non-Study RNs should not perform any study 
related procedures (i.e., catheter insertion, insertion 
site examinations evaluations_including 
documentation of both positive and negative 
findings, and catheter removal). In the event all RNs 
from the participating department(s)/unit(s) and 
ED are not able to participate in the study ....... . 
Only Study RNs from the medical surgical unit(s) 
or within the ED of the hospitaL'hospital network 
will perform study-related procedures .......... . 
Years of experience and other demographic 
information will be collected from the Study RNs 
in Stage 1 and the Study any RNs who join the 
study in Stage '1 J_and Stage 4. Study RNs 
participating in Stage 1 or joining the study in 
Stage J, should not be currently using the B. Braun 
Introcan Safety® IV Catheters and/or the 
STEADYCare™ Smallbore Extension Set utilized 
in this study. 
Subjects or his/her LAR (if appropriate) will oo 
consented provide consent before participating in 
Stage 1 ............ A subject who previously or 
currently has a catheter inserted due to medical 
need may participate in the study if he/she or 
his/her LAR (if appropriate) provides consent. 
Subjects will be classified as 1 or more of the 
following based on their individual participation 
in the study: 
• 
Screen Failure: Any subject who signed 
the Informed Consent or who's LAR 
provided consent and then the subject 
failed to meet the inclusion and or 
exclusion criteria. 
• 
Enrolled: Any subject who signed the 
US-N-H-1801 
Final Protocol Amendment 1 
Indication that multiple 
hospitals are allowed and 
that the Emergency 
Department can be used. 
Adding the allowance of 
the Emergency Department 
and of some Study RN 
requirements. 
Allowing for LARs. 
Clarification of the 
definitions of: Screen 
Failure, Enrolled, Early 
Withdrawal and Study 
Completer 
03 February 2021 
Page 8 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Section 4.3: 
Interruption or 
Discontinuation of 
Treatment 
Section 5: 
INVESTIGATINAL 
DEVICE: DETAILS 
OFSTUDY 
PRODUCT 
Section 5.2: Product 
Handling and 
Accountability 
03 February 2021 
Informed Consent or who's LAR 
provided consent and then the subject 
met all of the inclusion and exclusion 
criteria, 
• 
Early Termination: Any subject who 
was Enrolled but never had an 
attempted PIVC insertion or who was 
Enrolled and did not have a successful 
PIVC insertion by a study RN, 
• 
Early Withdrawal: Any subject who was 
Enrolled, but who voluntarily withdrew 
their consent or was withdrawn by their 
LAR or was withdrawn by the PI, 
• 
Study Completer: Any Enrolled Subject 
who had a successful PIVC insertion by 
a Study RN and had the PIVC removed 
for any reason 
Sttbjeets must meet all offue inemsion eriteria and 
none of the e~.eh:1sion eriteria before enrollment in 
the st1:1dy. 
A subject may also be withdrawn by his/her LAR or 
!n'. the Investigator or B. Braun due to a serious 
protocol violation or ifit is determined it is in the 
best interest of the subject. In the event a subject 
withdraws has or was withdravm from the study 
before the first attempt of a PIVC insertion or has 
no successful stick by a Study RN, emnpleting all 
reqtlirements of the Stage in whieh he/she is 
partieipating, he/she will be considered an Early 
Termination from the study. In the event a 
subject or his/her LAR withdraws consent or the 
PI removes the subject from the study for any 
reason, the subject will be considered an Early 
Withdrawal. a non st1:1dy eompleter and vt'-ill be 
replaeed to ensl:lfe there are at least 316 s1:1eeessful 
PIVC plaeements in Stage 1 and at least 316 
s1:1eeessful PIVC plaeements in Stage 4. 
The devices in the B. Braun PA Program are all 
cleared for marketing or exempt from clearance 
by the FDA. There will be no study specific 
product labels. 
Only study related supplies provided by B. Braun 
will be used by Study RNs on patients/subjects in 
participating medieab'sl:lfgieal 1:IDit(s) in Stages 3 and 
4 . ......... During Stages 3 and 4, Study RNs will 
only utilize All PIVC insertions eompleted by these 
St1:1dy R.Ns in this 1:lflit(s) will 1:1tilize the B. Braun 
Peripheral Advantage products. for patients in 
Stage 3 (Run In) and patients who eonsent to be 
srudy sttbjeets for Stage 4 (Post Intervention) . 
. . . . . . . B. Braun products supplied for this study 
€anne-t are not to be used for patients outside of the 
US-N-H-1801 
Final Protocol Amendment 1 
Clarification on an "Early 
Termination" subject. 
Allowing for LARs. 
Indicating that the B. Braun 
products are FDA approved 
or exempt. 
Clarification regarding who 
should use B. Braun study 
supplies. 
Page 9 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Section 5.3: Product 
Storage 
Section 6: STUDY 
VISITS ANSD 
ASSESSMENTS 
Section 6.1: Stage 1: 
Baseline 
03 February 2021 
selected medicab'surgical unit/department(s) where 
this study is being conducted. 
In the event any Use of the B. Braun PIVC devices 
are inadvertently used by Study RNs for non-study 
patients in the participating ED or medical/surgical 
department(s)/unit(s) is allov1ed; howeyer, no study 
related information will be recorded. 
Unused Introcan Safety® IV Catheters and unused 
STEADYCare™ Smallbore Extension Sets will be 
retained or destroyed by the study site per their 
internal policies. 
The Christie Vein Viewer® Vision2 is to be 
stored/retained oo in the medical/surgical floor 
unit/department(s) at where the study is being 
conducted. 
The Introcan Safety® IV Catheters and the 
STEADYCare™ Smallbore Extension Set are also to 
be stored oo in the medical/surgical floor 
unit/department(s) at which in which the study is 
being conducted. 
This study will be conducted in the medical surgical 
floorAmit(s) of nrultiple individual hospitals and or 
nrultiple hospitals w-ithin a the Hospital/Hospital 
Network ED or medical surgical unit/departments. 
Only participating Study RNs from the participating 
1:Hlitidepartment will perform study related 
procedures. 
Subjects must have a medical condition requiring IV 
treatment through a PIVC anticipated to lasting for 
at least 48 hours. 
The Study Flow Diagram was updated and 
replaced. 
Any RNs from the participating floors or the 
hospital ED are eligible to participate in Stage 1 
of the study and after completion of protocol 
training and any required site specific training 
(GCP, consent process, etc.) will be considered 
Study RNs. Only St1:1Ely RJ,~s will participate in this 
Subjects or their LARs who are consented by.!! 
Study RN who has received protocol training (St1:1Ei-y 
and who meet all the inclusion and none of the 
exclusion criteria will be able to participate in this 
Stage ........ During this Stage, all Study RNs will 
continue with their routine standard-of-care with 
regard to PIVC insertion technique and continue 
US-N-H-1801 
Final Protocol Amendment 1 
Clarification on the 
restrictive use of the 
B.Braun products. 
Text allowing for multiple 
study sites. 
Clarification of the 
requirements for the 48 hour 
PIVC duration to be 
"anticipated". 
Flow Diagram updated to 
current Terminology, no 
new study procedures were 
added. 
Requirements for Study 
RNs. 
Page 10 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Section 6.2: Stage 2: 
Intervention 
Section 6.3: Stage 3: 
Run-In 
03 February 2021 
using the Institution's standard PIVC product~. 
The proG-1:let type catheter brand, eatheter insertion 
site location, characteristics, number of attempts, 
dressing condition, complications and removal 
information (length of indwell time in hours and 
reason for removal) will be recorded in the Gase 
Report Form (CRF) or electronic Case Report Form 
( eCRF) for each insertion attempt. In addition, the 
catheter and site of insertion will be examined daily 
and any relevant clinical findings will be recorded in 
the GR:FleCRF. The subject's baseline demographic 
data (age, gender) will be collected. If the attempts 
fail and the subject requires a different catheter, 
such a PICC, Midline or Central Catheter, or a 
PIVC form a different manufacturer will be 
recorded in the eCRF. 
After completion of the Baseline Stage, i:l:ll Study 
RNs are permitted to will take part in the 
Intervention which includes protocol training, if 
needed, and education on the use ofB. Braun PA 
Note: an RN may join the study in Stage 2 
provided they have completed the site's required 
research training and protocol specific training 
before participating in Stage 2. Before the 
Intervention begins, the Study RNs will take part Hi 
¥ariettS complete the skill assessment tools to assess 
evaluate their confidence and knowledge with 
respect to catheter insertion. These assessments are 
located in Appendix 1: PIVC Insertion Confidence 
Assessment and Appendix 2: PIVC Knowledge 
Assessment. The Study RNs will then receive the 
full training on how to use B. Braun PA Program, 
which consists of the PA Education Program 
Curriculum, and in-service on the use of the 
Christie Vein Viewer® Vision2, Introcan Safety® IV 
Catheters and STEADYCare™ Smallbore Extension 
Set. ..... . 
After completion of the Intervention, the Study RN s 
will take part in skill assessments of their PIVC 
therapy confidence and knowledge with respeet to 
B. BraooPA ..... . 
Only Study RNs -a=em that completed Stage 2 will 
participate in this Stage. After the successful 
completion of the Intervention, it is anticipated that 
all current PIVC catheters and extension sets will be 
collected from the department(s)/unit(s) and only B. 
Braun PA products will be available Hi the medieal 
sttrgieal ooit(sdepartmeat or l:ID:it). If this cannot be 
accomplished, the Investigator or designee will take 
reasonable measures to ensure that all Study RNs use 
only B. Braun and Christie Medical study products 
on their patients. 
These Study RNs will use the B. Braun devices for 
US-N-H-1801 
Final Protocol Amendment 1 
Requirements for Study 
RNs. 
Requirements for Study 
RNs. 
Page 11 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
Section 6.4: Stage 4: 
Post-lnterventional 
Section 7: Skill 
Performance 
Assessments 
Section 8: DEVICE 
REMOVAL 
03 February 2021 
all their patients requiring PIVC patieats from this 
point forward. 
Study subjects or their LARs will be consented by 
Study RNs and must meet all inclusion and none of 
the exclusion criteria prior to any study related 
procedures,. iaelttaiag the 1:1se of B. Bral:lH PA of 
proooets. The Study RNs should use the B. Braun 
devices for all of their PIVC study subjects. Study 
RNs will use their standard procedures and 
supplies for PIVC dressing. The catheter insertion 
site loeatioa, characteristics, number of attempts, 
dressing condition, complications and removal 
information (length of indwell time in hours and 
reason for removal) will be recorded in the 
GRWeCRF for each attempt. The subject's 
demographic data (age, gender) will be collected. Ia 
aaaitioa, t!he catheter and site of insertion will be 
examined daily and any relevant clinical findings 
will be recorded in the GRWeCRF ..... .If the 
attempts fail and the subject requires a different 
catheter, such a PICC, Midline or Central 
Catheter, or a PIVC form a different 
manufacturer will be recorded in the eCRF. 
At the eompletioa of the Post laterveatioaal Stage 
St1:1ay ID-~s will assess their pereeptioa of B. Bral:lH 
PA iH the eliflieal settiag 1:1siag a Likert seale 
q-ttestionnaire. 
After completion of the study, the RNs will re-
take the skill assessments of their confidence and 
knowledge with respect to B. Braun PA. These 
assessments are located in Appendix 1: PIVC 
Insertion Confidence Assessment and Appendix 
2: PIVC Knowledge Assessment. 
Minor editorial changes to Table 1 
Clarifying the appropriate 
assessment tools. 
The Study RNs will take skill/performance 
Clarification of when the 
assessments (PIVC Insertion Confidence Assessment 
RN Assessments will be 
and PIVC Knowledge Assessment) before and after 
conducted. 
completion of the RN Intervention and will reeora 
their pereeptioas of the PA Eooeatioa CtHTirnll:lffi 
again after the completion of the Post-Interventional 
Stage ia a Likert seale q-ttestimrnaire. 
It is expected that the Study RNs will evaluate the 
Clarification of catheter 
catheter site before they remove the catheter is 
removal. 
removed. Oaee the eatheter is remocvea by the St1:1ay 
RN,s~tandard facility protocols will be followed for 
catheter removal and the dressing of the IV site. 
+his The dressing of the IV site may be performed 
by a non-study nurse, however the date and time of 
removal and the reason for removal must be 
Page 12 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Section 8: DEVICE 
REMOVAL 
Section 12.4: 
Determination of 
Sample Size; Subjects 
Section 8.1: Catheter 
Removal Due to 
Complication 
Section 8.1: Catheter 
Removal Due to 
Complication 
Section 12.4 
Determination of 
Sample Size: Subjects 
Section 10: STUDY 
PROCEDURES 
Section 11 .1: Adverse 
Events 
Section l l.3:-8erieus 
Adverse Event 
Reporting 
03 February 2021 
recorded. 
A catheter may be removed at the end of a subject's 
medical treatment requiring PIVC therapy, as a 
result of complications or for any other reason 
determined by the treating clinician. 
If a sttbj eets is w-ithdra~ before reaehi-ag at least 4 g 
hottrs with the 61:H'feflt PIVC i-asertion, he/she w-ill be 
eonsidered a non study eompleter and vlill be 
replaeed to ensttre there will be at least 316 
sueeessful PIVC plaeemeats in Stage 1 and at least 
316 sweeessful PIVC plaeemeats in Stage 4 
If the PIVC was removed as a result of treatment 
completions (i.e., subject no longer requires a PIVC) 
he/she will be considered a Study Completer. and 
In addition, if he/she was subsequently discharged 
from the facility, then he/she may re-enter the study 
in the same or different Stage if a re-admission for 
any reason is required. 
Seetion g .1: Catheter Removal Dtle to Complieation 
If the PIVC was removed as a result of treatment 
completion (i.e., subject no longer requires a PIVC) 
he/she will be considered a Study Completer. In 
addition, if he/she was subsequently discharged 
from the facility, then he/she may re-enter the study 
in the same or different Stage if a re-admission for 
any reason is required. 
Replace Table 2: Schedule of Events 
There is no required routine collection of vital signs, 
physical examinations (other than the catheter site) 
or clinical laboratory evaluations. 
AE collection for each subject will begin after the 
ICF is signed and will continue until the completion 
of all study procedures or until the subject 
withdrawals consent or is withdrawn from the 
study. 
An Adverse Device Effect (ADE) is an AE 
determined to be related to the use of the 
investigational device. 
All events related to both the standard-of-care 
products used in the hospital and the B. Braun 
Peripheral Advantage Program devices and any 
required procedures will be evaluated by the 
Investigator for determination as AEs, SAEs, 
ADEs and documented on the electronic case 
report form (eCRF). AE collection for each 
US-N-H-1801 
Final Protocol Amendment 1 
Clarification of a Study 
Completer and potential for 
re-emollment. 
Deletion of unnecessary 
Section header 
Clarification of a Study 
Completer and potential for 
re-emollment. 
Table 2: Schedule of Events 
was revised for clarification 
of procedures. 
Clarification of the 
collection interval for AE's. 
Defining an Adverse Device 
Event. 
Section was restructured and 
new text added for 
clarification of events and 
reporting information. 
Page 13 

B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Section 12.1: 
Statistical Analyses for 
Primary Endpoint 
03 February 2021 
subject will begin after the informed consent form 
is signed and will continue until the completion of 
all study procedures or subject withdrawal from 
the study. 
All SAEs will be followed until the Investigator 
and Sponsor agree the event is satisfactorily 
resolved (i.e., resolved, stabilized or returned to 
baseline). Preliminary reports of SAEs must be 
followed by detailed descriptions later on, 
including clear and anonymized photocopies of 
hospital case reports, consultant reports, autopsy 
reports, and other documents when requested and 
applicable. SAE reports must be made whether 
or not the Investigator considers the event to be 
related to the study device. 
For adverse devise effeets aHd devise malfunetioas, 
aotifieatioa eaH be made as deseribed ia fue 
followiag paragraphs: 
1. Coataet the stttdy safety team to iaform them 
that yoH are reportiag aH adverse devise effeet or 
devise malfunetioa Hsiag a Form FDA 3500 
MedWateh. IfyoH are ooable to speak with a live 
safety assoeiate, leave a message with fue aame of 
the lw;estigator, yotlf aame, the telephoae Htlillber 
where yoH eaa be reaehed, aHd the protoeol rnunber 
aHd tide. 
l-----In the event of an adverse device effect or 
device malfunction, form FDA 3500 MedWatch 
must be completed. Fax ore mail the E-mail Form 
FDA 3500 MedWatch and any supporting 
documentation to the stHdy safety team as instructed 
below within 24 hours of becoming aware of the 
event. Verify SHeeessful traHsmissioa by obtaiHiag a 
Fa" Coafirraatioa Report; this eoafirraatioa page 
shoHld be kept with the SAE report ia ease futtlfe 
moaitoriag is reqttired. 
a. During Stage 1 of the protocol, notification 
shall be made by email to 
chris.curtin@bbraunusa.com and 
diana.valencia@bbraunusa.com. 
b. During Stage 4 of the protocol, notification 
shall be made to the Sponsor's Medical Affairs 
Department either by phone call: 800-854-6851 or 
email to medinfo.us@bbraunusa.com. 
The statistical analysis will compare the 
rate/percentage of eatheter removals Eltte to 
complications between B. Braun PA and hospital's 
current standard of care PIVC utilizing a binomial 
test (such as Fisher's Exact Test). The source data 
are the evaluations of catheter placements, i.e., were 
there any complications? (Yes/No). was there 
removal of the catheter due to complications? 
US-N-H-1801 
Final Protocol Amendment 1 
Clarification of primary 
assessment will be overall 
complications and not 
associated with or without 
catheter removal. 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
Section 12.2: 
Statistical analyses for 
Secondary Endpoint 
Section 12.4: 
Determination of 
Sample Size 
(Yes/No) (e.g., due to phlebitis, occlusion, infection, 
dislodgement, infiltration, etc.). 
In the event the subject or his/her LAR withdraws 
Clarification of the 
consent or is withdrawn by the PI, for any reason, 
documentation of date and 
and the catheter is still in place, the date and time 
time ofIV removal in the 
of withdrawal will be used as a surrogate for the 
date and time of removal. 
Only RNs from the hospital's ED or medical 
surgical 
departments/unit ef.too 
hospital/hospital network will participate. 
Subjects or their LAR will be consented before 
participating in Stage 1 and/or Stage 
4 ................ .If the PIVC was removed as a result 
of treatment completions (i.e., subject no longer 
requires a PIVC) he/she will be considered a Study 
Completer. In addition, if he/she was 
subsequently discharged from the facility, then 
he/she may re-enter the study in the same or different 
Stage if a re admission for any reason is required. 
event of an early 
withdrawal. 
RN's can now come from 
the Emergency Department 
Clarifying that a Study 
Completer due to no longer 
needing the IV can re-enroll. 
Allowing for LARs. 
Section 13.1: Informed 
Each subject or his/her LAR (if appropriate) must 
Allowing for LARs. 
Consent 
be informed that participation in the study is 
voluntary, ......... . 
The subject or his/her LAR (if appropriate) should 
Allowing for LARs. 
read and consider the statement before signing and 
Section 13.2: Data 
Handling 
03 February 2021 
dating it, and he/she should be given a copy of the 
signed document. No subject can enter Stage 1 
and/or Stage 4 of the study or have any study related 
procedures performed before informed consent has 
been obtained from him/her or his/her LAR (if 
appropriate). 
In the event a subject re-enrolls in the study, 
he/she or his/her LAR (if appropriate) must sign 
another Informed Consent. 
In the event a subject with a successful PIVC 
insertion drops out or is withdrawn from the study, 
B. Braun or its designee will be informed in a timely 
manner and the date and time of withdrawal will 
be recorded. In the event a subject has or was 
withdrawn from the study before a PIVC insertion 
attempt or a successful PIVC insertion by a Study 
RN, eompleting all reqttirements of the Stage he/she 
is partieipating, he/she will be considered an Early 
Termination from the study. In the event a 
subject or his/her LAR (if appropriate) withdraws 
consent or the PI removes the subject from the 
study for any reason, the subject will be consider 
as an Early Withdrawal.a non st1:1Ely eompleter and 
·.vill be replaeed to ensl:lfe that there are at least 316 
Clarification regarding 
re-signing the consent in the 
event of a re-enrolhnent. 
Clarification on an "Early 
Termination" subject. 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
Section 13.6 
Monitoring 
03 February 2021 
sttccessful PIVC placemeats ia Stage 1 aad at least 
316 sttccessful PIVC placemeats ia Stage 4. In the 
event of a subject's withdrawal of consent or any 
other early withdrawal that also did not result in 
the IV being removed, the date and time of that 
withdrawal will be used as a surrogate for the 
date and time of removal of the IV and the 
subject's data will be treated in the same manner 
as a study completer. In this case, the subjects will 
not be allowed to re-enroll in to the study . 
. . . . . . . . . If the PIVC was removed as a result of 
treatment completions (i.e., subject no longer 
requires a PIVC) he/she will be considered a Study 
Completer. In addition, if he/she was 
subsequently aad he/she ·uas discharged from the 
facility, then he/she may re- enter the study in the 
same or different Stage ifa re-admission for any 
reason is required. 
During the study, B. Braun (and/or designee) may 
visit the site regularly or remotely to evaluate the 
completeness of study records, the accuracy of 
entries on the tR:F/eCRF, the adherence to the 
protocol and ICH-GCP guidelines, and the progress 
of emollment, and to ensure that B. Braun PA is 
being stored, dispensed and accounted for according 
to specifications. Remote monitoring and/or 
source data verification will be performed if a site 
has imposed, or is subject to, travel and/or visit 
restrictions for in-person visits due to 
circumstances such as those related to the Covid-
19 pandemic or if the monitor is subject to travel 
restrictions. 
US-N-H-1801 
Final Protocol Amendment 1 
Clarification of a Study 
Completer and potential for 
re-emollment. 
Text to allow for the 
requirements for remote 
monitoring and source data 
verification. 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
SYNOPSIS 
Title of Study: 
Protocol Number: 
Investigators/Study Sites: 
Phase of Development: 
Objectives: 
Study Design: 
Study Population 
Selection of Patients: 
03 February 2021 
Assessment of the Effect of B. Braun Peripheral Advantage Program on 
Complications, Indwell Time and First Stick Success of PIVC Therapy 
US-N-H-1801 
A multi-center study to include individual hospitals or multiple hospital locations 
within a hospital network. 
4 (post-marketing device study) 
Primary Objective 
The primary objective of this study is to evaluate the impact ofB. Braun Peripheral 
Advantage (PA) Program on the incidence of complications associated with PIVC 
use. 
Secondary Objective 
The secondary objectives of this study are to evaluate the effect of B. Braun PA on 
catheter indwell time, first attempt success rates (first stick success), and aggregate 
costs associated with catheter insertion. 
Single sequence clinical study designed to evaluate the effectiveness of B. Braun 
PA on improved clinical outcomes, indwell time and first stick success of PIVC 
using B. Braun PA by Registered Nurses (RNs). 
The study will be divided into 4 Stages: 3 Clinical Stages and I Interventional 
(Educational) Stage. These 4 Stages are: Baseline (Stage I), Intervention (Stage 2, 
education), Run-In (Stage 3), and Post-Interventional (Stage 4). 
The 3 clinical 
Stages require patient care which includes daily follow-up care for the catheter 
(Baseline, Run-In, and Post-Interventional). The Intervention (education) Stage is 
for the RNs to be trained in B. Braun PA and thus will not involve any patients. 
The study will be conducted in the Emergency Department (ED) and/or Medical 
Surgical (MS) floor(s)/unit(s) in multiple hospitals. A core group of RNs on all 
shifts who have completed the protocol required training (Study RNs) will 
participate in the study. In the event all RNs from the participating Unit are not able 
to participate in the study, the Investigator will take reasonable measures to ensure 
all specifically study related procedures are performed by the Study RNs. 
Registered Nurses: RNs from the ED or MS unit(s)/department(s) of the hospital 
can be on any shift and will not be required to have a minimum level of clinical 
experience. Any RNs from the participating floors or the hospital ED are eligible to 
participate in Stage I of the study. After completion of protocol training and any 
required site specific training (GCP, consent process, etc.), they are considered a 
Study RN. 
Those Study RNs who have not completed all of the required training in the 
B. Braun Peripheral Advantage Program in Stage 2 cannot continue on to Stages 3 
and 4 and thus will be removed from participation in the study. 
The sites participating in the study cannot be currently using the B. Braun Introcan 
Safety® IV Catheters or the STEADYCare™ Smallbore Extension Set or the 
Christie VeinViewer utilized m this study m any of the participating 
units/departments at the time of initiating the study. 
Subjects: At least 632 PIVC successful placements are to be performed in the 
medical surgical unit running the study (Stage I, at least 316 successful PIVC 
placements and Stage 4, at least 316 successful PIVC placements). Subjects or 
his/her Legally Authorized Representative (if appropriate) will be consented by 
Study RNs before participating in Stage I and/or Stage 4 and may participate in 
either, or both, of those stages. Subjects consented for Stage I may participate as 
patients in Stage 3 (Run-In). 
Inclusion Criteria 
RNs must complete all of the required B. Braun trainings in Stage 2 in order to 
participate in Stages 3 and 4. 
Subjects must meet all of the following Inclusion Criteria: 
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B. Braun Medical Inc. 
US-N-H-1801 
Peripheral Advantage Curriculum 
Final Protocol Amendment 1 
Planned Sample Size: 
B. Braun Peripheral Advantage 
Program: 
Components of the B. Braun 
Peripheral Advantage Program: 
Criteria for Evaluation: 
03 February 2021 
1. 
Male or female aged 2'.18 years; 
2. 
The subject or the subject's LAR voluntarily agrees that the subject will 
participate in this study and is able to understand and sign the Informed 
Consent Form (ICF); 
3. 
Have a medical condition that requires a PIVC anticipated to last for at 
least 48 hours; 
4. 
Have intact skin at the site of insertion; 
5. 
If the patient has an existing IV in one arm he/she must have a viable 
contralateral arm for additional PIVC insertion. 
Exclusion Criteria 
Subjects must not meet any of the following Exclusion Criteria: 
1. 
Are currently participating in another medical device or pharmaceutical 
study; 
2. 
In the opinion of the Investigator, would not be suitable candidates for this 
study; 
3. 
The subject or his/her LAR is an employee of the Investigator or study 
center, or the sponsor, or have direct involvement in the study or other 
studies under the direction of that Investigator or study center, or are a 
family member of the employees or the Investigator; 
4. 
Have a laboratory confirmed bloodstream infection within 48 hours prior 
to participation in the study. The assessment is based on clinical 
observations and not routine for all subjects; 
5. 
Patient has an existing non study related IV 
6. 
Was removed from any Stage of the study due to an AE associated with 
thePIVC. 
At least 632 successful PIVC placements (316 successful PIVC placements in 
Stage 1 and 316 successful PIVC placements in Stage 4) are required to complete 
the study. The number of PIVC insertion attempts will be recorded. 
Education Curriculum, Christie VeinViewer® Vision2, Introcan Safety® IV 
Catheters, and STEADYCareTM Smallbore Extension Set 
PA Education Curriculum - developed and delivered by B. Braun Medical Inc. 
Christie Vein Viewer® Vision2 - manufacturer Christie Medical Holdings Inc 
Introcan Safety® IV Catheters - manufacturer B. Braun Medical Inc. 
STEADYCare™ Smallbore Extension Set with Wedge™ Catheter Stabilizer -
manufacturer B. Braun Medical Inc. 
The devices in the B. Braun PA Program are all cleared for marketing or exempt 
from clearance by the FDA. There will be no study specific product labels. 
Subjects must have a medical condition that requires the insertion of a PIVC 
anticipated to be at least 48 hours for their medical treatment. 
There will be 3 Clinical Stages and 1 Educational Stage to this study: Baseline 
(Stage 1), Intervention (Stage 2, education), Run-In (Stage 3), and Post-
Interventional (Stage 4 ). The 3 Clinical Stages require patient care including daily 
follow-up care for the catheter (Baseline, Run-In, and Post-Interventional). The 
Intervention (Education) Stage is only for the RNs to be trained in B. Braun PA and 
thus will not involve any patients. 
Stage 1: Any RNs from the participating floors or the hospital ED are eligible to 
participate in Stage 1 of the study. After completion of protocol training and any 
required site specific training (GCP, consent process, etc.), they are considered a 
Study RN. During the Baseline Stage, the RNs will continue with their routine 
standard-of-care with regards to PIVC insertion technique used and Institution's 
PIVC type. Subjects or their LAR (if appropriate) will provide consent and they 
must meet all inclusion and none of the exclusion criteria prior to the RN 
performing a study related PIVC procedure and collection of data. 
Stage 2: The Intervention Stage will be conducted after the completion of the 
Baseline Stage. Note: an RN may join the study in Stage 2 provided they have 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
Study Endpoints: 
Statistical Methods and Planned 
Analyses: 
03 February 2021 
completed the site's required research training and protocol specific training before 
participating in Stage 2. All Study RNs may take part in this Stage for education and 
skill assessment/perception to assess the change in their confidence and knowledge 
after learning the PA Curriculum. B. Braun PA Program includes: Christie 
VeinViewer® Vision2, Introcan Safety® IV Catheters, SIBADYCare™ Smallbore 
Extension Set, and the PA Curriculum. The PA Education Curriculum consists of 
approximately 2 hours of individual self-paced on-line training and approximately 
2 hours oflive classroom training and practice. 
Stage 3: Only RNs who have completed Stage 2 may participate in this Stage of the 
study and will be considered a Study RN. The Run-In Stage will last approximately 
3 weeks and serves to familiarize the Study RNs with the B. Braun devices in a 
clinical setting. The Study RNs will use the B. Braun devices for all their PIVC 
insertions from this point forward, when feasible. 
Stage 4: Only Study RNs may participate in this Stage of the study. The Post-
Interventional Stage will be conducted after the conclusion of the Run-In Stage and 
will assess the effectiveness of B. Braun PA in a clinical setting. Subjects or his/her 
LAR (if appropriate) will provide consent and they must meet all inclusion and none 
of the exclusion criteria prior to the Study RN performing a study related PIVC 
procedure and collection of data. B. Braun devices will continue to be used during 
this Stage. 
Data obtained from the use of the current standard-of-care (Stage 1) and B. Braun 
PA (Stage 4) will be used in the assessment of the Primary and Secondary 
Endpoints. 
Primary Endpoint 
The primary endpoint for this study is the rate/percentage of complications 
(e.g., phlebitis/thrombophlebitis, occlusion, infection (localized or Catheter Related 
Bloodstream Infection [CRBSI]), dislodgement or infiltration, extravasation, 
accidental removal, etc.). 
Secondary Endpoints 
• 
Indwell time for catheters (measured in hours) 
• 
First attempt insertion success rate (first stick success) for PIVC 
• 
Rate of insertion of a Peripherally Inserted Central Catheter (PICC) or 
Midline Catheter due to inability to insert the PIVC or removal of the 
initial PIVC due to complications (rescue PICC or rescue Midline) 
• 
Healthcare costs associated with PIVC use in a clinical setting. 
Standard statistical methods will be utilized in this study to analyze all data. 
Endpoints that measure rates (e.g., primary endpoint of rate of complications) will 
be tested for significance using a binomial test (such as Fisher's exact test). 
Continuous endpoints will be tested for significance using standard parametric tests 
(such as Student's t-test), or non-parametric equivalent (such as Wilcoxon signed 
rank test) if parametric methods are found to be inappropriate. 
Two interim analyses are planned for the purpose of sample size re-estimation. 
Using the method of Pocock & Mehta, the sample size can be either held constant or 
increased - it cannot be reduced based on the results of the re-estimation. 
Interim Data Analysis Stage 1: Upon successful completion of approximately 70% 
of the originally planned PIVC placements in Stage 1, an interim analysis of the 
primary endpoint on raw (uncleaned) data will be performed. If the observed 
complication rate is statistically significantly greater than 50%, the sample size will 
not be modified. If the observed complication rate is not statistically significantly 
greater than 50%, the sample size may be re-estimated (increased). 
Interim Data Analysis Stage 4: Upon successful completion of approximately 50% 
of the initial sample size in Stage 4, another interim analysis on raw (uncleaned) 
data for the complications will be performed. This sample size re-estimation will 
follow the method of Pocock and Mehta to calculate the conditional power of the 
study to conclude that the complication rate m Stage 4 1s lower than the 
complication rate in Stage 1, given the observed complication rates at the interim 
analysis. 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
In the event the conditional power is found to be in the Favorable or Unfavorable 
zone, the study will continue to the originally planned sample size in Stage 4. In the 
event the conditional power is in the Promising zone, the total study sample size 
may be increased to the required sample size to achieve conditional power of 90% at 
the completion of the study. 
Additional details on the statistical analyses will be describe in the separate 
Statistical Analysiss Plan (SAP). 
Safety Analyses: 
All adverse events reported over the course of the study will be categorized based 
on MedDRA coding system and tabulated by system organ class, and preferred term 
within the system organ class. 
Events may include, but are not limited to: minor and major complications such as 
infection or thrombophlebitis, device failures (i.e., disconnection, twisted port hub, 
leakage, and failure of the safety feature) and needlestick injuries. 
03 February 2021 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
TABLE OF CONTENTS 
US-N-H-1 801 
Final Protocol Amendment 1 
SYNOPSIS ............................................................................................................................. 17 
TABLE OF CONTENTS ..................................................................................................... 21 
LIST OF TABLES ............................................................................................... 23 
LIST OF FIGURES .............................................................................................. 23 
LIST OF ABBREVIATIONS .............................................................................................. 24 
1 
INTRODUCTION ....................................................................................................... 25 
1.1 
Rationale for the Study ....................................................................................... 26 
2 
STUDY OBJECTIVES AND ENDPOINTS ............................................................. 26 
2.1 
Study Objectives ................................................................................................ .26 
2.1.1 
Primary Objective ................................................................................ 26 
2.1.2 
Secondary Objective ............................................................................ 26 
2.2 
Study Endpoints .................................................................................................. 26 
2.2.1 
Primary Endpoint ................................................................................. 26 
2.2.2 
Secondary Endpoint ............................................................................. 26 
3 
INVESTIGATIONAL PLAN ..................................................................................... 27 
3.1 
Study Design ....................................................................................................... 27 
3.2 
Study Population: Registered Nurses and Subjects ........................................... .28 
3.2.1 
Registered Nurses ................................................................................ 28 
3.2.2 
Subjects ................................................................................................ 28 
4 
SELECTION AND DISCONTINUATION OF TREATMENT ............................. 29 
4.1 
Inclusion Criteria ................................................................................................ 29 
4.2 
Exclusion Criteria ............................................................................................... 29 
4.3 
Interruption or Discontinuation of Treatment.. ................................................... 30 
5 
INVESTIGATIONAL DEVICE: DETAILS OF STUDY PRODUCT ................... 30 
5 .1 
Description of B. Braun Peripheral Advantage Program Components .............. 30 
5.2 
Product Handling and Accountability ................................................................. 31 
5.3 
Product Storage ................................................................................................... 31 
5.4 
Package Labeling ................................................................................................ 32 
6 
STUDY VISIT AND ASSESSMENTS ....................................................................... 32 
6.1 
Stage 1: Baseline ................................................................................................. 34 
6.2 
Stage 2: Intervention ........................................................................................... 34 
03 February 2021 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
6.3 
Stage 3: Run-In ................................................................................................... 34 
6.4 
Stage 4: Post-Interventional ................................................................................ 35 
7 
SKILL PERFORMANCE ASSESSMENTS ............................................................. 36 
8 
DEVICEREMOVAL .................................................................................................. 36 
9 
PROTOCOL INCIDENTS/DEVIATIONS ............................................................... 37 
9 .1 
Incidents .............................................................................................................. 3 7 
9.2 
Protocol deviation ............................................................................................... 37 
10 
STUDY PROCEDURES ............................................................................................. 38 
11 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS .................................. 38 
11 .1 
Adverse Events ................................................................................................... 38 
11.2 
Serious Adverse Events and Serious Adverse Device Effects ........................... .40 
11.3 
Event Reporting .................................................................................................. 40 
11 .4 
Reporting responsibility and procedures ........................................................... .41 
12 
STA TIS TI CAL ANALYSIS ....................................................................................... 42 
12.1 
Statistical Analyses for Primary Endpoint.. ....................................................... .42 
12.2 
Statistical Analyses for Secondary Endpoints ................................................... .42 
12.3 
Safety Analyses .................................................................................................. .43 
12.4 
Determination of Sample Size ........................................................................... .43 
12.5 
B. Braun Peripheral Advantage Program Nisit Compliance ............................ .44 
12.6 
Demographic and Baseline Characteristics ....................................................... .44 
13 
STUDY MANAGEMENT ........................................................................................... 45 
13.1 
Informed Consent. .............................................................................................. .45 
13.2 
Data Handling ..................................................................................................... 45 
13.3 
Source Documents ............................................................................................. .46 
13 .4 
Recording of data ............................................................................................... .46 
13. 5 
Record Retention ................................................................................................ 4 7 
13.6 
Monitoring .......................................................................................................... 47 
13. 7 
Quality Control and Quality Assurance ............................................................. .4 7 
14 
STUDY-SPECIFIC MATERIALS ............................................................................. 48 
15 
PROTOCOL AMENDMENT AND PROTOCOL DEVIATION ........................... 48 
15 .1 
Protocol Amendment ......................................................................................... .48 
15.2 
Protocol Deviations ............................................................................................ .48 
03 February 2021 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
16 
ETHICAL CONSIDERATIONS ................................................................................ 48 
17 
FINANCINGANDINSURANCE .............................................................................. 49 
18 
TERMINATION OR SUSPENSION OF STUDY .................................................... 49 
19 
CONFIDENTIALITY AND PUBLICATION POLICIES ...................................... 49 
19 .1 
Disclosure and confidentiality ........................................................................... .49 
19.2 
Publication Policy .............................................................................................. .49 
REFERENCES ...................................................................................................................... 51 
APPENDICES ....................................................................................................................... 53 
Appendix 1: PIVC Insertion Confidence Assessment.. ................................................. 54 
Appendix 2: PIVC Knowledge Assessment ................................................................... 55 
LAST PAGE .......................................................................................................................... 61 
LIST OF TABLES 
Table 1: Summary of Stage name, Stage number, number of subjects and product used or 
Intervention ............................................................................................................. 35 
Table 2: Schedule ofEvents .................................................................................................. 38 
Table 3: Classification of Adverse Events by Severity ........................................................... 39 
LIST OF FIGURES 
Figure 1 Study Flow Diagram ............................................................................................. 33 
03 February 2021 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
LIST OF ABBREVIATIONS 
Abbreviation 
ABS 
AE 
ADE 
B. Braun 
CFR 
DVD 
eCRF 
EEC 
ED 
FDA 
GCP 
ICF 
ICH 
IRB 
IV 
LAR 
PA 
PICC 
PIVC 
PUR 
RN 
SAE 
SIN 
SOP 
us 
USADE 
03 February 2021 
Definition 
Acrylonitrile-butadiene-styrene 
Adverse Event 
Adverse Device Event 
B. Braun Medical Inc. 
Code of Federal Regulations 
Digital Versatile Disc 
Electronic Case Report Form 
European Ethics Committee 
Emergency Department 
Food and Drug Administration 
Good Clinical Practice 
Informed Consent Form 
International Conference on Harmonization 
Institutional Review Board 
Intravenous 
Legally Authorized Representative 
Peripheral Advantage 
Peripherally Inserted Central Catheter 
Peripheral Intravenous Catheter 
Polyurethane 
Registered Nurse 
Serious Adverse Event 
Subject Identification Number 
Standard Operating Procedure 
United States 
Unanticipated Serious Adverse Device Effect 
US-N-H-1801 
Final Protocol Amendment 1 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
1 
INTRODUCTION 
US-N-H-1 801 
Final Protocol Amendment 1 
B. Braun Medical Inc. (B. Braun) is committed to enhancing clinical outcomes while 
managing workflow efficiencies. B. Braun leads the way in developing infusion therapy and 
pain management products and services that meet the highest standards for quality, safety, 
efficiency and sustainability. 
Peripheral intravenous catheters (PIVCs) are used to deliver medication and fluids directly 
into the bloodstream. The placement of PIVCs is the most common invasive hospital 
procedure. In the United States (US) alone, more than 300 million PIVCs are sold each year 
and 60% to 90% of hospitalized patients require an IV catheter (Helm, 2015). Despite the 
large medical demand for PIVCs, there is a high failure rate and large cost associated with 
replacing the catheter due to complications, not counting the need to perform unnecessary 
PIVC insertions. 
The Centers for Disease Control and Prevention (CDC) recommends rotating the PIVC site 
at 72 to 96-hour intervals to reduce the risk of infection and patient discomfort associated 
with phlebitis (O'Grady, 2002). However, typical catheter dwell times range from only 
1.9 to 2.5 days (Powell, 2008; Royer, 2003; Sheppard, 1999). Failures, which occur in 
anywhere from 35% to 70% of PIVCs, take the forms of phlebitis, infiltration, 
occlusion/mechanical failure, dislodgment, and infection (Helm, 2015; Maki, 1991; Shears, 
2006). A PIVC failure is considered to have occurred when the PIVC stops working safely 
before the end of the 72 to 96-hour limit or before the end of its intended dwell time (PIVC is 
no longer needed). These failures are associated with many factors, including the products 
used and the expertise of the clinician inserting and maintaining the PIVC, and add to the 
costs of intravenous (IV) therapy (Helm, 2015). 
While the initial cost of inserting a PIVC in the US is roughly between $28 and $35 for 
"first-stick" insertions, the costs of identifying, inserting, and removing a PIVC is repeated 
each time a failed catheter is replaced (Helm, 2015; Rickard, 2012; Webster, 2008). 
Additional costs come from treating the PIVC complications such as bleeding, hematoma 
formation, infusate extravasation, thrombophlebitis, and catheter-related bloodstream 
infection (Smith, 1998; Greig, 2002; Doellman, 2009; Hollenbeak, 2012). 
Numerous clinician PIVC knowledge and insertion skill deficits have been identified 
including patient assessment, insertion site selection, catheter selection and insertion, catheter 
securement, dwell time, complication identification and treatment, and compliance with best 
practice guidelines (Hadaway, 2012; Frey, 1998; Palefski, 2001; Abbas, 2007; Cicolini, 
2014). Keleekai et al. (2016) reported significant improvements in nurses' PIVC insertion 
knowledge, confidence, and skills in a simulated environment as a result of participation in a 
simulation-based, blended learning program. In addition, while not statistically significant, 
the intervention group demonstrated increased PIVC first stick success by 28 percentage 
points (from 53% to 81 %) during the study period, which represented a 53% increase in first 
stick success for this population of medical/surgical bedside nurses, average age 39.9 years 
(standard deviation [SD] = 12.6). For these reasons, there is a need to develop effective 
strategies to prevent the potential problems associated with vascular access that Registered 
Nurses (RNs) experience in clinical settings (Vinograd et.al, 2017). 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
This study is designed to assess the effect of the B. Braun Peripheral Advantage (PA) 
Program that includes clinician education and specific B. Braun peripheral intravenous (PIV) 
therapy products designed to improve the clinical outcomes associated with a PIVC. 
The study will be conducted in compliance with Food and Drug Administration (FDA) 
regulations, the ethical principles of the Declaration of Helsinki (Edinburgh, Scotland; 2000), 
the International Conference on Harmonization (ICH) -
Good Clinical Practice (GCP) 
Guidelines as currently amended, and all applicable Standard Operating Procedures (SOPs) 
of the study site. 
1.1 
Rationale for the Study 
The placement of PIVCs is the most common invasive hospital procedure. In the US alone, 
60% to 90% of hospitalized patients require an IV catheter (Helm, 2015). Despite this large 
medical demand for PIVCs, there is a high failure rate and large cost associated with 
replacing the catheter due to complications. 
The use of B. Braun PA, which includes PA Education Curriculum, Christie Vein Viewer® 
Vision2, Introcan Safety® IV Catheters, and STEADYCare™ Smallbore Extension Set may 
improve patient care at the bed side and decrease PIVC associated complications, resulting in 
increased catheter indwell time and improved financial outcomes. 
2 
STUDY OBJECTIVES AND ENDPOINTS 
2.1 
Study Objectives 
2.1.1 
Primary Objective 
The primary objective of this study is to evaluate the impact of B. Braun PA on the incidence 
of complications associated with PIVC use. 
2.1.2 
Secondary Objective 
The secondary objectives of this study are to evaluate the effect of B. Braun PA on catheter 
indwell time, first stick success rates (first stick success), and aggregate costs associated with 
catheter insertion. 
2.2 
Study Endpoints 
Data obtained from the use of the current standard-of-care (Stage 1) and of B. Braun PA 
(Stage 4) will be used in the assessment of the Primary and Secondary Endpoints. 
2.2.1 
Primary Endpoint 
The 
primary endpoint 
for 
this 
study 
1s 
the 
rate/percentage of complications 
( e.g., phlebitis/thrombophlebitis, occlusion, infection (localized or Catheter Related 
Bloodstream Infection (CRBSI), dislodgement or infiltration, extravasation, accidental 
removal, etc.). 
2.2.2 
Secondary Endpoint 
The secondary endpoints for this study are: 
• 
Indwell time for catheters with and without complications (measured in hours) 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
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Final Protocol Amendment 1 
• 
First attempt insertion success rate (first stick success) for PIVC 
• 
Rate of insertion of a Peripherally Inserted Central Catheter (PICC) or Midline 
Catheter due to inability to insert the PIVC or removal of the initial PIVC due to 
complications (rescue PICC or rescue Midline) 
• 
Impact of using B. Braun PA on the healthcare costs associated with PIVC use in a 
clinical setting. 
3 
INVESTIGATIONAL PLAN 
3.1 
Study Design 
This is a single sequence study to evaluate the effectiveness of B. Braun PA on improved 
clinical outcomes by decreasing PIVC complications, increasing PIVC indwell time, 
improving first PIVC stick success and improving estimated aggregated costs utilizing 
B. Braun PA. 
The study will be divided into 4 Stages: 3 Clinical Stages and 1 Interventional (Educational) 
Stage. These 4 Stages are: Baseline (Stage 1), Intervention (Stage 2, education), Run-In 
(Stage 3), and Post-Interventional (Stage 4). The 3 clinical Stages (Baseline, Run-In, and 
Post-Interventional) require patient care which includes daily follow-up care for the catheter. 
The Intervention (education) Stage (Stage 2) may include all RNs from the medical surgical 
floor(s)/unit(s) of the hospital/hospital network. This training in B. Braun PA will not involve 
any patients. 
The study will be conducted in the medical surgical floor( s )/unit( s) of multiple individual 
hospitals. Patients from the Emergency Department (ED) are also eligible to be enrolled. Any 
RNs from these floors or the hospital ED are eligible to participate in Stage 1 of the study. 
After completion of protocol training and any required site specific training (GCP, consent 
process, etc.) to the RNs will be considered Study RNs. The Study RNs from Stage 1 and any 
other RNs from the medical surgical floor(s)/unit(s) or the hospital ED who complete 
protocol training may participate in the intervention (Stage 2). The Study RNs on all shifts 
who have completed the protocol training/intervention (Stage 2) will participate in Stage 3 
and Stage 4 of the study. All Study RNs will be responsible for PIVC insertions and catheter 
examinations. Non-Study RNs should not perform any study related procedures (i.e., catheter 
insertion, insertion site examinations including documentation of both positive and negative 
findings, and catheter removal). In the event all RNs from the participating 
department(s)/unit(s) and ED are not able to participate in the study, the Investigator will 
take reasonable measures to ensure all study-related procedures are performed by the Study 
RNs. 
A minimum of 632 successful PIVC placements are required to complete the study 
(316 successful PIVC placements in Stage 1 and 316 successful PIVC placements in 
Stage 4). Each study Stage must be completed before proceeding to the next study Stage. The 
final sample sizes of Stage 1 and Stage 4 will be determined by the 2 interim analyses. 
The study will be conducted in compliance with this protocol, GCP, and any other applicable 
regulatory requirements. 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
3.2 
Study Population: Registered Nurses and Subjects 
US-N-H-1801 
Final Protocol Amendment 1 
Data obtained from all subjects who enroll in any Stage of the study and from the Study RNs 
will be included in analysis of safety and the study endpoints. 
3.2.1 
Registered Nurses 
Only Study RNs from the medical surgical unit(s) or within the ED of the hospital will 
perform study-related procedures. Registered nurses can be on any shift(s) and will not be 
required to have a minimum level of clinical experience. Any Study RN who does not 
complete all of the B. Braun trainings in Stage 2 cannot continue on to Stages 3 and 4 and 
thus is removed from participation in the study. Years of experience and other demographic 
information will be collected from the Study RNs in Stage 1 and any RNs who join the study 
in Stage 2. Study RNs participating in Stage 1 or joining the study in Stage 2 should not be 
currently using the B. Braun Introcan Safety® IV Catheters and/or the STEADYCare™ 
Smallbore Extension Set utilized in this study. 
3.2.2 
Subjects 
Subjects will be enrolled into the study to ensure there are at least 632 successful PIVC 
placements, with at least 316 successful PIVC placements in Stage 1 and 316 successful 
PIVC placements in Stage 4. In Stage 3, Study RNs will familiarize themselves with 
B. Braun devices in a clinical setting by using them exclusively as standard-of-care for PIVC 
patients. Stage 3 does not require a statistically defined number of PIVC placements and will 
run for about 3 weeks. During this time it is anticipated that each Study RN will perform 
approximately 10 insertions (Reznek 2002). 
Subjects or his/her LAR (if appropriate) will provide consent before participating in Stage 1 
(Baseline) and Stage 4 (Post-Interventional) and may participate in one, or both, of those 
stages. Subjects consented for Stage 1 may participate as patients in Stage 3 (Run-In). A 
subject who previously or currently has a catheter inserted due to medical need may 
participate in the study if he/she or his/her LAR (if appropriate) provides consent. However, 
consent must be given before any study-related procedures including the replacement of a 
catheter utilizing the hospital's standard-of-care (Baseline Stage 1) or B. Braun PA 
(Post-Intervention Stage 4). The replacement catheter must be inserted in a different arm 
(see Exclusion criteria 5 below). 
Subjects will be classified as 1 or more of the following based on their individual 
participation in the study: 
• 
Screen Failure: Any subject who signed the Informed Consent or who's LAR 
provided consent and then the subject failed to meet the inclusion and or exclusion 
criteria, 
• 
Enrolled: Any subject who signed the Informed Consent or who's LAR provided 
consent and then the subject met all of the inclusion and exclusion criteria, 
• 
Early Termination: Any subject who was Enrolled but never had an attempted PIVC 
insertion or who was Enrolled and did not have a successful PIVC insertion by a 
study RN, 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1 801 
Final Protocol Amendment 1 
• 
Early Withdrawal: Any subject who was Enrolled, but who voluntarily withdrew their 
consent or was withdrawn by their LAR or was withdrawn by the Pl, 
• 
Study Completer: Any Enrolled Subject who had a successful PIVC insertion by a 
Study RN and had the PIVC removed for any reason 
4 
SELECTION AND DISCONTINUATION OF TREATMENT 
RNs must complete all of the required B. Braun trainings in Stage 2 in order to participate in 
Stages 3 and 4. 
4.1 
Inclusion Criteria 
Subjects must meet all of the following Inclusion Criteria: 
1. Male or female aged 2:18 years; 
2. The subject or the subject's LAR voluntarily agrees that the subject will participate 
in this study and is able to understand and sign the Informed Consent Form (ICF); 
3. Have a medical condition that requires a PIVC anticipated to last for at least 
48 hours; 
4. Have intact skin at the site of insertion; 
5. If the patient has an existing IV in one arm he/she must have a viable contralateral 
arm for additional PIVC insertion. 
4.2 
Exclusion Criteria 
Subjects must not meet any of the following Exclusion Criteria: 
1. Are currently participating in another medical device or pharmaceutical study; 
2. In the opinion of the Investigator, would not be suitable candidates for this study; 
3. The subject or his/her LAR is an employee of the Investigator or study center or 
sponsor, have direct involvement in the study or other studies under the direction of 
that Investigator or study center, or are a family member of the employees or the 
Investigator; 
4. Have a laboratory confirmed bloodstream infection within 48 hours prior to 
participation in the study. The assessment is based on clinical observations and not 
routine for all subjects; 
5. Patient has an existing non study related IV; 
6. Was removed from any Stage of the study due to an AE associated with the PIVC. 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1 801 
Final Protocol Amendment 1 
4.3 
Interruption or Discontinuation of Treatment 
In accordance with legal requirements and ICH-GCP guidelines, every subject has the right 
to refuse further participation in the study at any time and without providing a reason. A 
subject may also be withdrawn by his/her LAR or by the Investigator or B. Braun due to a 
serious protocol violation or if it is determined it is in the best interest of the subject. In the 
event a subject withdraws from the study before the first attempt of a PIVC insertion or has 
no successful stick by a Study RN, he/she will be considered as an Early Termination from 
the study. In the event a subject or his/her LAR withdraws consent or the PI removes the 
subject from the study for any reason, the subject will be considered an Early Withdrawal. 
5 
INVESTIGATIONAL DEVICE: DETAILS OF STUDY PRODUCT 
The devices in the B. Braun PA Program are all cleared for marketing or exempt from 
clearance by the FDA. There will be no study specific product labels. 
Manufacturers of Components of B. Braun Peripheral Advantage Program: 
• 
PIVC Education Curriculum - developed and delivered by B. Braun Medical Inc. 
• 
Christie Vein Viewer® Vision2 - manufacturer Christie Medical Holdings Inc 
• 
Introcan Safety® IV Catheters - manufacturer B. Braun Medical Inc. 
• 
STEADYCare™ Smallbore Extension Set with Wedge™ Catheter Stabilizer -
manufacturer B. Braun Medical Inc. 
5.1 
Description of B. Braun Peripheral Advantage Program Components 
Christie Vein Viewer® Vision2 
The adjustable head can be positioned over any part of the anatomy, leaving the clinician's 
hands free to perform the procedure, using the trademarked Eyes of Patient (EOP™) 
technique. The Christie Vein Viewer® Vision2 unit contains the following: optical head 
assembly, arm, battery, battery compartment door, power module, arm lock, power cord, 
handle, basket, cart, cart base, wheel lock, wheel, cart base counterweight, cable clips, user 
guide, software (compact disc [CD]) and training video (digital versatile disc [DVD]), and 
universal serial bus (USB) cable. 
This study will utilize the optional Stability Mount 
(S-Mount) which allows Christie Vein Viewer® Vision2 to be positioned over any part of the 
anatomy, leaving the clinician's hands free to perform the procedure. 
The Christie 
Vein Viewer® Vision2 should be stored between -l 0°F to + 140°F (-23 °C to +60°C) and 
operate between +60°F to +86°F ( + l 6°C to + 30°C). 
Intro can Safety® IV Catheters 
The Introcan Safety® IV Catheters is designed to minimize needlestick injuries and has been 
available in the US since 2002. This device is made of polyurethane (PUR), polypropylene 
(PP), acrylonitrile-butadiene-styrene (ABS), chrome-nickel steel or fluorinated ethylene 
propylene (FEP). This sterile device is for single use only. The specific gauges and lengths 
to be supplied will be appropriate for the study facility. 
STEADYCare™ Smallbore Extension Set with Wedgern Catheter Stabilizer 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
The STEADYCare™ Smallbore Extension set is comprised of the STEADYCare™ Smallbore 
Extension Set with Wedge™ Catheter Stabilizer, Female Luer Lock Connector, and 
Spin-Lock® Connector. This sterile device is for single use only. 
5.2 
Product Handling and Accountability 
Only study related supplies provided by B. Braun will be used by Study RNs on 
patients/subjects participating in Stages 3 and 4. These Study RNs will be the only personnel 
tasked with study related PIVC insertions/removals and assessing for complications on their 
associated units. During Stages 3 and 4, Study RNs will only utilize the B. Braun Peripheral 
Advantage products. In the event that standard-of care products are still available alongside 
B. Braun study-related supplies in this unit(s), the Investigator or designee will take 
appropriate measures to ensure study subjects receive only the B. Braun devices. B. Braun 
products supplied for this study are not to be used for patients outside of the 
unit/department(s) in which this study is being conducted. Study related supplies must be 
stored as per Hospital/Hospital Network SOP's and guidelines as well as the conditions 
specified on B. Braun PA labels. 
The Investigator or a designee must maintain a complete record of the shipment and receipt 
of B. Braun PA in an accountability log. This log must be kept current and should contain at 
least the date and amount received, lot number (s), and expiration date(s). Whenever a 
B. Braun PIVC device is used for a study subject in Stage 4, the use will be recorded in the 
eCRF and on the accountability log. In the event any B. Braun PIVC devices are 
inadvertently used by Study RNs for non-study patients in the participating ED or 
medical/surgical department(s)unit(s), no study related information will be recorded. The use 
of B. Braun PA for non-study patient standard-of-care will be recorded in the accountability 
log. 
During the course of the study, the used Introcan Safety® IV Catheters and the used 
STEADYCare™ Smallbore Extension Set must be disposed of in accordance with hospital 
policy and local regulations governing the disposal of medical and/or hazardous waste. If a 
device fails at any point during the study, it must be returned to B. Braun in accordance with 
B. Braun SOPs for device malfunction/return. The Christie Vein Viewer® Vision2 will be 
returned to B. Braun at the conclusion of the study, unless otherwise agreed upon in writing. 
Unused Introcan Safety® IV Catheters and unused STEADYCare™ Smallbore Extension Sets 
will be retained or destroyed by the study site per their internal policies. 
When requested in writing by B. Braun, unused study related supplies must be destroyed by 
the Investigator, provided such disposition does not expose humans to risks. Records shall 
be maintained by the Principal Investigator of any such alternative disposition of the 
investigational devices. These records must show the identification and quantity of each unit 
disposed of, the method of destruction (taking into account the requirements of local law), 
and the person who disposed of the study related supplies. Such records will be maintained 
in the Study File. 
5.3 
Product Storage 
The Christie VeinViewer® Vision2 is to be stored/retained in the unit/department(s) where 
the study is being conducted. 
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B. Braun Medical Inc. 
Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
The Introcan Safety® IV Catheters and the STEADYCare™ Smallbore Extension Set are also 
to be stored in the unit/department(s) in which the study is being conducted. If there is 
insufficient space on this floor to store all the IV associated products received, it is 
acceptable to store the remaining IV associated supplies in a limited access/secure area 
separate from the study floor. These materials must be clearly identified as to be used only 
for B. Braun study US-N-H-1801. 
The Introcan Safety® IV Catheters and the STEADYCare™ Smallbore Extension Set must 
be used prior to the expiration dates noted on the package labels. 
To assure that only the Study RNs complete the subject PIVC insertions using the Introcan 
Safety® IV Catheters, the STEADYCare™ Smallbore Extension Set and the Christie 
Vein Viewer® Vision2, these products will be stored in a separate locked area. Access to this 
restricted area will be provided only to the appropriate study staff Use of study related 
products will be documented on the accountability log and, for consented subject, in the 
eCRF. 
The Sponsor will provide product with a shelf life of approximately one ( 1) year. 
5.4 
Package Labeling 
The devices in the B. Braun PA Program are all currently cleared for marketing or exempt 
from clearance by the FDA. There will be no study specific product labels. 
6 
STUDY VISIT AND ASSESSMENTS 
This study will be conducted in the ED or medical surgical unit/departments. 
Only 
participating 
Study 
RNs 
will 
perform 
study 
related 
procedures. 
Baseline 
demographic/clinical experience information from RNs will be obtained. This information 
will include age, gender, title/function, shift, and years of clinical experience. 
Subjects must have a medical condition requiring IV treatment through a PIVC anticipated to 
last for at least 48 hours. A subject may participate in one or more of the 3 Stages that 
require patient care (Baseline, Run-In, and Post-Interventional). 
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Peripheral Advantage Curriculum 
US-N-H-1801 
Final Protocol Amendment 1 
A study flow diagram outlining the main study procedures is shown in Figure 1. 
Figure 1 
Study Flow Diagram 
Pre-Study: Registered Nurses to have 
institutional and protocol required 
trainings. 
Stage 1 - Baseline: Consenting of 
Subjects. Demographic data 
collection from Subjects and Study 
RNs. Study RNs will use current 
standard of care insertion devices 
Stage 2 - Intervention and Skill 
Assessment: Study RN's must 
participate in the training of the B.Braun 
Peripheral Advantage Education 
Curriculum. 
Stage 3 - Run-in: Study RNs to become familiar 
with using the Christie Vein Viewer® Vision2, 
Introcan Safety® IV Catheter, STEADYCare™ 
Small bore Extension Set of B.Braun Peripheral 
Advantage Program in a clinical setting. No 
clinical data will be collected. 
Stage 4 - Post-Interventional: 
Consenting of Subjects and 
demographic data collection. Study 
RN's to use B.Braun Peripheral 
Advantage Program products 
l 
I 
Final RN assessments 
I 
I 
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B. Braun Medical Inc. 
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6.1 
Stage 1: Baseline 
US-N-H-1801 
Final Protocol Amendment 1 
Any RNs from the participating floors or the hospital ED are eligible to participate in Stage 1 
of the study and after completion of protocol training and any required site specific training 
(GCP, consent process, etc.) will be considered Study RNs. 
Subjects or their LAR who are consented by a Study RN and who meet all the inclusion and 
none of the exclusion criteria will be able to participate in this Stage. At least 316 successful 
PIVC placements are required in the Baseline Stage. During this Stage, Study RNs will 
continue with their routine standard-of-care with regard to PIVC insertion technique and 
continue using the Institution's standard PIVC product. The catheter brand, insertion site 
location, characteristics, number of attempts, dressing condition, complications and removal 
information (length of indwell time in hours and reason for removal) will be recorded in the 
electronic Case Report Form (eCRF) for each insertion attempt. In addition, the catheter and 
site of insertion will be examined daily and any relevant clinical findings will be recorded in 
the eCRF. The subject's baseline demographic data (age, gender) will be collected. If the 
attempts fail and the subject requires a different catheter, such a PICC, Midline or Central 
Catheter, or a PIVC form a different manufacturer will be recorded in the eCRF. 
6.2 
Stage 2: Intervention 
After completion of the Baseline Stage, Study RNs will take part in the Intervention which 
includes protocol training, if needed, and education on the use ofB. Braun PA. Note: an RN 
may join the study in Stage 2 provided they have completed the sites required research 
training and protocol specific training before participating in Stage 2. Before the Intervention 
begins, the Study RNs will complete the skill assessment tools to evaluate their confidence 
and knowledge with respect to catheter insertion. These assessments are located in Appendix 
1: PIVC Insertion Confidence Assessment and Appendix 2: PIVC Knowledge Assessment. 
The Study RNs will then receive the full training on how to use B. Braun PA Program, which 
consists of the PA Education Program Curriculum, and in-service on the use of the Christie 
VeinViewer® Vision2, Introcan Safety® IV Catheters and STEADYCare™ Smallbore 
Extension Set. The PA Education Curriculum consists of approximately 2 hours of 
individual, self-paced on-line training and approximately 2 hours of live classroom training 
and practice. 
After completion of the Intervention, the Study RNs will take part in skill assessments of 
their PIVC therapy confidence and knowledge. These assessments are located in Appendix 
1: PIVC Insertion Confidence Assessment and Appendix 2: PIVC Knowledge Assessment. 
This Stage does not include subjects and must be completed before proceeding to the Run-In 
Stage of the study. 
6.3 
Stage 3: Run-In 
Only Study RNs that completed Stage 2 will participate in this Stage. After the successful 
completion of the Intervention, it is expected that all current PIVC catheters and extension 
sets will be collected from the department(s)/unit(s) and only B. Braun PA products will be 
available. If this cannot be accomplished, the Investigator or designee will take reasonable 
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US-N-H-1801 
Final Protocol Amendment 1 
measures to ensure that all Study RNs use only B. Braun and Christie Medical study products 
on their patients. 
This Stage will last approximately 3 weeks in order for the Study RNs to become familiar 
with the B. Braun devices in a clinical setting. It is anticipated that each Study RN will 
perform approximately 10 insertions during this 3 week time period (Reznek, 2002). 
These Study RNs will use the B. Braun devices for all their patients requiring PIVC from this 
point forward. There is no minimum number of patients required to complete this Stage, and 
clinical data on these patients will not be collected. 
6.4 
Stage 4: Post-Interventional 
Only Study RNs will participate in this Stage. Upon completion of the Run-In Stage, the 
Post-Interventional Stage will begin. At least 316 successful PIVC placements are required 
in this Stage. Study subjects or their LAR will be consented by Study RNs and must meet all 
inclusion and none of the exclusion criteria prior to any study related procedures. The Study 
RNs should use the B. Braun devices for all of their PIVC study subjects. Study RNs will 
use their standard procedures and supplies for PIVC dressing. The catheter insertion site, 
characteristics, number of attempts, dressing condition, complications and removal 
information (length of indwell time in hours and reason for removal) will be recorded in the 
eCRF for each attempt. The subject's demographic data (age, gender) will be collected. The 
catheter and site of insertion will be examined daily and any relevant clinical findings will be 
recorded in the eCRF. At the time of catheter removal the reason for removal of the catheter 
will be documented. If the attempts fail and the subject requires a different catheter, such a 
PICC, Midline or Central Catheter, or a PIVC form a different manufacturer will be recorded 
in the eCRF. 
After completion of the study, the Study RNs will re-take the skill assessments of their 
confidence and knowledge with respect to B. Braun PA. These assessments are located in 
Appendix 1: PIVC Insertion Confidence Assessment and Appendix 2: PIVC Knowledge 
Assessment. 
A summary of the study Stage name, Stage number, number of subjects/patients and product 
training used or Intervention is displayed in Table 1. 
Table 1: Summary of Stage name, Stage number, number of subjects and product used 
or Intervention 
Stage Identification 
Baseline (Stage 1) 
Intervention (Stage 2, 
Education) 
Run-In (Stage 3) 
Post-Interventional (Stage 4) 
# Subjects/Duration 
Product/Intervention 
316 successful PIVC placements 
Hospital PIVC Standard-of-Care 
RNs only/ training a 
B. Braun Peripheral Advantage 
Education Curriculum a+ product 
training 
- 3 weeks 
B. Braun Supplies h 
316 successful PIVC placements 
B. Braun Peripheral Advantage Supplies 
b 
a B. Braun Peripheral Advantage Education Curriculum= Approximately 2 hours of self-paced on-line training 
followed by approximately 2 hours live/hands on class room training on the use of the PA products 
h B. Braun Peripheral Advantage supplies= Christie Vein Viewer® Vision2, Introcan Safety® IV Catheters, and 
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Peripheral Advantage Curriculum 
STEADYCare™ Smallbore Extension Set 
7 
SKILL PERFORMANCE ASSESSMENTS 
US-N-H-1801 
Final Protocol Amendment 1 
The Study RNs will take skill/performance assessments (PIVC Insertion Confidence 
Assessment and PIVC Knowledge Assessment) before and after completion of the RN 
Intervention and again after the completion of the Post-Interventional Stage. 
The 
skill/performance assessments (PIVC Insertion Confidence Assessment and PIVC 
Knowledge Assessment) are presented in Appendix 1: 
PIVC Insertion Confidence 
Assessment and Appendix 2: PIVC Knowledge Assessment. 
8 
DEVICE REMOVAL 
It is expected that the Study RNs will evaluate the catheter site before the catheter is 
removed. Once the catheter is removed by the Study RN, Standard facility protocols will be 
followed for catheter removal and the dressing of the IV site. The dressing of the IV site 
may be performed by a non-study nurse, however the date and time of removal and the 
reason for removal must be recorded. 
A catheter may be removed at the end of a subject's medical treatment, as a result of 
complications or for any other reason determined by the treating clinician. If PIVC therapy is 
still required after catheter removal, the subject may continue to receive PIVCs in accordance 
with his/her treating physician. If the PIVC was removed as a result of complications, the 
subject may not continue in or re-enter the study and will be considered a Study Completer. 
Complications will be assessed as potential Adverse Events ( AEs) as described in Section 11 . 
If the PIVC was removed as a result of treatment completion (i.e., subject no longer requires 
a PIVC) he/she will be considered a Study Completer. In addition, if he/she was subsequently 
discharged from the facility, then he/she may re-enter the study in the same or different Stage 
if a re-admission for any reason is required. 
The Study RN or designee will record in the eCRF if the PIVC was removed at any time due 
to any of the following complications: phlebitis/thrombophlebitis, occlusion, infection 
(localized or Catheter Related Bloodstream Infection [CRBSI]), dislodgement or infiltration, 
extravasation, or accidental removal. If it is medically appropriate for the subject, the PIVC 
may also be removed due to other conditions(s). The subject may continue to receive PIVC 
catheters in accordance with his/her medical treatment. If the PIVC was removed for a 
complication, then the subject may not continue or re-enter into the study and he/she is 
considered a Study Completer. Complications will be assessed as potential AEs as described 
in Section 11 . 
If the PIVC was removed as a result of treatment completion (i.e., subject no longer requires 
a PIVC) he/she will be considered a Study Completer. In addition, if he/she was subsequently 
discharged from the facility, then he/she may re-enter the study in the same or different Stage 
if a re-admission for any reason is required. 
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9 
PROTOCOL INCIDENTS/DEVIATIONS 
US-N-H-1801 
Final Protocol Amendment 1 
Procedures and forms for reporting clinical study incidents and deviations will be reviewed 
during the site initiation prior to study execution. All incidents and deviations will be 
recorded in the eCRF. 
9.1 
Incidents 
A Study Incident is defined as any problem involving any of the study devices, reference 
methods, procedures, equipment, and human subjects as a result of execution of this protocol. 
Study Incidents may adversely ( or potentially adversely) affect human safety, the integrity of 
the evaluation data, and/or the operation of devices or systems. Any incident which affects 
the health, safety, and welfare of human subjects will be reported as an Adverse Event (AE) 
(See Section 11). In the event an Incident results in an injury to a Study RN, the incident will 
be evaluated by the Investigator to determine the severity (mild, moderate, severe) and 
relationship to B. Braun PA (none, unlikely, possible, probable, or definite). 
Examples of Study Incidents that are not AEs may be mislabeling or adulteration of the 
investigational device, device malfunctions that do not contribute to or cause an AE, or 
damage to devices caused by shipping or handling. Device malfunctions are defined as 
failure of an investigational medical device to perform in accordance with its intended 
purpose when used in accordance with the instructions for use or clinical investigational 
protocol. Incidents resulting in an AE or protocol deviation will be documented in the EDC. 
9.2 
Protocol deviation 
Deviations from the protocol should not occur. If deviations occur, the Investigator must 
inform B. Braun or its designee and the site's clinical research coordinator. The implications 
of the deviation will be reviewed and discussed. 
Any deviation must be documented, including a description of the deviation, why the 
deviation occurred, the date of occurrence, the action taken, and the impact, if any, to the 
subject, clinician and/or the study. 
Major Deviation Reports should be completed and forwarded to B. Braun or its designee no 
later than 5 working days after becoming aware of the deviation. 
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10 STUDY PROCEDURES 
Table 2 outlines the timing of assessments to be performed throughout the study. 
See 
Section 6 for additional details of study procedures. 
Table 2: Schedule of Events 
Stage of the study 
2 - Intervention 
and Skill 
4 - Post-
Procedures 
Pre- Study 1 - Baseline 
Assessments 
3 - Run-in Inte rve ntional 
Registered Nurses 
a 
RN's 
Study RN's 
Study RN's 
Study RN's 
Study RN's 
Required Site Specific Training (ie, GCP, 
consent process, etc) 
X 
B. Braun Protocol Training 
X 
Demographics 
X 
Xb 
Standard PIVC insertion 
X 
B. Braun Education and Peripheral Advantage 
Product Training 
X 
PIVC Insertion Confidence Assessment and 
PIVC Knowledge Assessment 
Xe 
X" 
B. Braun Peripheral Advantage Product 
Insertion 
X 
X 
Subjects 
Demographics 
X 
X 
Informed Consent 
X 
X 
Inclusion, Exclusion Criteria 
X 
X 
Daily catheter monitoring 
X 
X 
Adverse Events 
--continuous--
a All RN's may participate in Stages l and 2. However, only B. Braun Peripheral Advantage-trained Study RN's will participate in 
Stages 3 and 4. 
0 Demographic information to be obtained onlv if a new Study RN enters the study in Stage 2. 
c To be performed before and after the Intervention (Stage 2) and again at the completion of the study (Stage 4). 
The Investigator or designee will explain the nature of the study, the study procedures, and 
the potential risks to each patient. Before any study-related procedures occur, the patient 
must voluntarily sign the ICF. 
There is no required routine collection of vital signs, physical examinations ( other than the 
catheter site) or clinical laboratory evaluations. Safety assessments will comprise the 
collection, review and documentation of AEs, Serious Adverse Events (SAEs) and Adverse 
Device Events (ADEs). 
11 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
11.1 Adverse Events 
Study safety will be evaluated by assessment of AEs. 
The Study RNs in this study are subjected to minimal health risk from the use of the devices 
and are anticipated to be experienced users of PIVC devices. The subjects enrolled in this 
study may be exposed to the standard health risks associated with PIVC insertion. All events 
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related to both the standard-of-care products used in the hospital and the B. Braun PA and 
any required procedures will be evaluated for determination as AEs and documented on the 
eCRFs. 
An AE is any untoward medical occurrence, unintended disease or injury or any untoward 
clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, 
whether or not related to the investigational device. AEs may include, but are not limited to, 
premature device removal, minor and major complications, infection, thrombophlebitis, 
accidental needlestick injuries, and device failures (i.e., disconnection, twisted port hub, 
leakage, or failure of safety feature). AE collection for each subject will begin after the ICF is 
signed and will continue until the completion of all study procedures or until the subject 
withdraws consent or is withdrawn from the study. 
AEs will be reported by the Investigator and the Sponsor will use the reported AE term to 
determine the MedDRA system organ class and preferred term. The investigator will also 
report the AE severity (mild, moderate, severe) and relationship of the AE to either the 
standard-of-care products used in the hospital or the B. Braun PA. 
No exposure hazard is expected. The investigational devices were manufactured according 
to Good Manufacturing Practices (GMPs). 
Specific guidelines for classifying AEs by intensity are provided in Table 3. 
Table 3: Classification of Adverse Events by Severity 
Mild: An event that is easily tolerated by the patient, causing minimal discomfort and not interfering 
with everyday activities. 
Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. 
Severe: An event that prevents normal everyday activities. 
When changes in the severity of an AE occur more frequently than once a day, the maximum 
severity for the event should be noted. If the severity category changes over a number of 
days, then those changes should be recorded separately (with distinct onset dates). 
An Adverse Device Effect (ADE) is an AE determined to be related to the use of the 
investigational device. 
Specific guidelines for classifying AEs by relationship are provided below: 
Definite - The adverse event is clearly related to the study device: the event has a 
temporal relationship to the study device, follows a known pattern of response, or is 
otherwise logically related to the study device, and no alternative cause is present. 
Probable - The adverse event is likely related to the study device: the event has a 
temporal relationship to the study device, follows a known or suspected pattern of 
response, or is otherwise logically related to the study device, but an alternative cause 
may be present. 
Possible - The adverse event is unlikely related to the study device: the event does 
not follow a clear temporal relationship to the study device or does not follow a 
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known pattern of response, or is otherwise possibly to be due to the subject's clinical 
state or other modes of therapy. 
In some cases, the adverse event may not be adequately assessed because information is 
insufficient or contradictory and/or the data cannot be verified or supplemented. Maximum 
effort will be made to define and categorize the event and avoid these situations. 
If 
relatedness remains uncertain, then classify the event as "possible". 
Unlikely - The adverse event can be reasonably explained by another cause and/or 
the relationship with the use of the device seems not relevant, but additional 
information may be obtained. 
Not Related - The adverse event is clearly not related to the study device: the event 
has no temporal or other relationship to the administration of the investigational 
device follows no known or suspected pattern of response, and an alternative cause is 
present. 
11.2 Serious Adverse Events and Serious Adverse Device Effects 
An AE is considered "serious" if in the view of either the Investigator or Sponsor, it meets 
1 or more of the following criteria: 
• 
• 
• 
• 
• 
• 
• 
led to death, 
led to serious deterioration in the health of the subject, that either resulted in 
a life-threatening illness or injury, or 
a permanent impairment of a body structure or a body function, or 
in-patient or prolonged hospitalization, or 
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, or 
led to fetal distress, fetal death or a congenital abnormality or birth defect 
A serious ADE is an Adverse Device Effect that has resulted in any of the consequences 
characteristic of an SAE. 
11.3 Event Reporting 
All events related to both the standard-of-care products used in the hospital and the B. Braun 
Peripheral Advantage Program devices and any required procedures will be evaluated by the 
Investigator for determination as AEs, SAEs, ADEs and documented on the electronic case 
report form (eCRF). AE collection for each subject will begin after the informed consent 
form is signed and will continue until the completion of all study procedures or subject 
withdrawal from the study. 
All SAEs will be followed until the Investigator and Sponsor agree the event is satisfactorily 
resolved (i.e., resolved, stabilized or returned to baseline). Preliminary reports of SAEs must 
be followed by detailed descriptions later on, including clear and anonymized photocopies of 
hospital case reports, consultant reports, autopsy reports, and other documents when 
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requested and applicable. 
SAE reports must be made whether or not the Investigator 
considers the event to be related to the study device. 
An SAE occurring during the study must be reported to the Sponsor or designee. Any such 
SAE due to any cause, whether or not related to the study devices, must be reported within 
24 hours of occurrence or when the Investigator becomes aware of the event. 
Appropriate remedial measures should be taken to treat the SAE, and the response should be 
recorded. Clinical, laboratory, and diagnostic measures should be employed as needed in 
order to determine the etiology of the problem. 
All SAEs will be followed until the 
Investigator and Sponsor agree the event is satisfactorily resolved. The Sponsor will report 
SAEs to the FDA as required. 
In the event of an adverse device effect or device malfunction, form FDA 3500 MedWatch 
must be completed. E-mail Form FDA 3500 MedWatch and any supporting documentation 
as instructed below within 24 hours of becoming aware of the event. 
a. During Stage 1 of the protocol, notification shall be made by email to 
chris. curtin@b braunusa. com and diana. valencia@bbraunusa.com. 
b. During Stage 4 of the protocol, notification shall be made to the Sponsor's 
Medical Affairs Department either by phone call: 800-854-6851 or email to 
medinfo.us@bbraunusa.com. 
Unanticipated Serious Adverse Device Effects (USADEs) are serious adverse device effects 
which by nature, incidence, severity or outcome have not been identified in the current 
version of the risk analysis report. SAEs which are attributed by the Investigator to the 
patient's underlying medical condition and unrelated to the study device will not be reported 
as USADEs. The Sponsor is responsible for expedited reporting ofUSADEs to the FDA. 
The Investigator is responsible for notifying the Institutional Review Board (IRB). 
11.4 Reporting responsibility and procedures 
A needlestick-related event reportable under 21 CFR Part 803 includes any death, serious 
injury, or malfunction for either the standard-of-care products used in the hospital or the 
B. Braun PA products as detailed below: 
A death report should be submitted by a user facility, importer, and manufacturer if the 
device may have caused or contributed to the death of an individual. 
A serious injury report (Form FDA 3500 MedWatch) should be submitted by a user facility, 
importer, and manufacturer if the device resulted in an injury to an individual and the injury 
was life-threatening, resulted in permanent impairment of a body function or permanent 
damage to a body structure, or necessitated medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a body structure. 
A device malfunction report (Form FDA 3500 MedWatch) should be submitted by an 
importer and manufacturer if the device failed to perform as intended and would be likely to 
cause or contribute to a death or serious injury if the needlestick event reoccurred. B. Braun 
should also be notified of SAEs and of any follow-up information in writing using the Form 
FDA 3500 MedWatch, as is practical, and depending on local regulations (Needlesticks, 
2002). 
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12 ST A TIS TI CAL ANALYSIS 
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The statistical evaluation will be performed using the Statistical Analysis Software (SAS®) 
Version 9.2 or higher (SAS Institute, Cary, NC). 
All data will be summarized using 
descriptive statistics, and where necessary, data will also be listed either by subject or by 
event, as appropriate. For continuous variables, data will be summarized with the number of 
subjects (N), mean, standard deviation (SD), median, minimum, and maximum. 
For 
categorical variables, data will be tabulated with the number and proportion of subjects for 
each category. Where appropriate, 95% two-sided confidence intervals may be presented. If 
the observed data are found not to follow a normal distribution, appropriate non-parametric 
methods may be employed. Two interim analyses are planned. 
All hypothesis tests will be two-sided and performed at the alpha=0.05 level. 
No 
adjustments to the alpha level will be made for the number of significance tests performed. 
Data obtained from all subjects who enroll in any Stage(s) of the study and data obtained 
from the RN' s participating in the study will be included in analysis of safety and the study 
endpoints. 
Additional data driven subgroup analyses may be performed. Additional details on the 
statistical analyses will be describe in the separate Statistical Analyses Plan (SAP). 
12.1 Statistical Analyses for Primary Endpoint 
Incidence of Complications Associated with PIVC Use 
The statistical analysis will compare the rate/percentage of complications between B. Braun 
PA and hospital's current standard-of-care PIVC utilizing a binomial test ( such as Fisher's 
Exact Test). The source data are the evaluations of catheter placements, i.e., were there any 
complications? (Yes/No), was there removal of the catheter due to complications? (Yes/No) 
(e.g., due to phlebitis, occlusion, infection, dislodgement, infiltration, etc.). 
12.2 Statistical Analyses for Secondary Endpoints 
Standard statistical methods will be utilized in this study to analyze all data. Secondary 
endpoints that measure rates (e.g., first stick success) will be tested for significance using a 
binomial test (such as Fisher's exact test). Continuous endpoints will be tested for 
significance using standard parametric tests (such as Student's t-test), or non-parametric 
equivalent (such as Wilcoxon signed rank test) if parametric methods are found to be 
inappropriate. 
Indwell Times: The source data are the indwell times measured for all catheters 
( e.g., catheter withdrawn due to complications, end of medical treatment, routine catheter 
change, end of treatment or voluntary withdrawal of subject from study). The indwell time is 
calculated from the time of catheter insertion until the time of catheter removal for any 
reason. In the event the subject or his/her LAR withdraws consent or is withdrawn by the Pl, 
for any reason, and the catheter is still in place, the date and time of withdrawal will be used 
as a surrogate for the date and time of removal. 
A survival analysis will be performed to further understand the difference in indwell times. 
A catheter will be considered to have been a failure/event if it is removed due to any 
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complication or failure of the unit. It will be considered censored/non-event if it is removed 
as it is no longer needed, i.e., the condition improves or the subject is discharged from the 
hospital. 
12.3 Safety Analyses 
Adverse events will be summarized as an overall incidence of at least one event, incidence 
within system organ class only, and incidence by system organ class and preferred term. 
Events may include, but are not limited to: minor and major complications, infection, 
thrombus, phlebitis, accidental needle sticks, and device failures (i.e., disconnection, twisted 
port hub, leakage, and failure of the safety feature). Section 11 of this protocol details AE 
definitions and relationship classifications. 
A Statistical Analysis Plan (SAP) will be prepared after the protocol and eCRF are approved. 
This document will provide further details regarding the definition of analysis variables and 
analysis methodology to address all study objectives. The SAP will serve as a complement 
to the protocol and supersedes it in the case of any differences. 
12.4 Determination of Sample Size 
Based on initial study design assumptions, at least 316 successful PIVC insertions are 
necessary to complete Stage 1 and at least 316 successful PICV insertions are necessary to 
complete Stage 4 in order to detect a statistically significant difference between the current 
standard-of-care and B. Braun PA at 90% power and two-sided confidence level of 5.0%. 
The estimated complication rate in Stage 1 is 50% and the estimated complication rate in 
Stage 4 is 35%. (Helm, 2015) 
Two interim analyses are planned, solely for the purpose of sample size re-estimation. Using 
the method of Pocock & Mehta, the sample size can be either held constant or increased - it 
cannot be reduced based on the results of the re-estimation. 
Interim Data Analysis Stage 1 
Upon successful completion of approximately 70% of the originally planned PICV 
placements in Stage 1, an interim analysis of the primary endpoint on raw (uncleaned) data 
will be performed. The observed complication rate in Stage 1, utilizing actual data collected 
in the study up to this point, will be compared to the originally estimated complication rate of 
50%. If the observed complication rate is statistically significantly greater than 50%, the 
sample size will not be modified, and Stage 1 enrollment will continue to the original sample 
size of at least 316 successful PIVC insertions. If the observed complication rate is not 
statistically significantly greater than 50%, the sample size may be re-estimated with the 
assumed Stage 1 complication rate equal to the observed interim analysis complication rate, 
with other assumptions held constant. 
Interim Data Analysis Stage 4 
The final sample size in Stage 1 (based on the results of the sample size re-estimation in 
Stage 1) will be used as the initial sample size for Stage 4. Upon successful completion of 
approximately 50% of the initial sample size in Stage 4 (which is determined at the interim 
analysis in Stage 1 ), another interim analysis on raw (uncleaned) data for the complications 
will be performed. This sample size re-estimation will follow the method of Mehta and 
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Pocock to calculate the conditional power of the study to conclude that the complication rate 
in Stage 4 is lower than the complication rate in Stage 1, given the observed complication 
rates at the interim analysis. The conditional power (CP) will be categorized into one of the 
three following zones: 
• 
Favorable: CP 2: 90% 
• 
Promising: 41 % :S CP < 90% 
• 
Unfavorable: CP < 41 % 
In the event the conditional power is found to be in the Favorable or Unfavorable zone, the 
study will continue to the originally planned sample size in Stage 4 (i.e., final sample size in 
Stage 1 ). In the event the conditional power is in the Promising zone, the total study sample 
size may be increased to the required sample size to achieve conditional power of 90% at the 
completion of the study. Note that only the sample size in Stage 4 can be increased at this 
time, as the data collection in Stage 1 has been completed. 
Registered nurses: Only RNs from the hospital's ED or medical surgical departments/unit 
will participate. Registered nurses can be on any shift and will not be required to have a 
minimum level of clinical experience. There is no minimum number ofRNs required. 
Subjects: Subjects or their LAR will be consented before participating in Stage 1 and/or 
Stage 4 and may participate in either, or both, of those stages. Subjects consented for Stage 1 
may participate as patients in Stage 3 (Run-In). If the PIVC was removed for a complication, 
then the subject may not continue or re-enter into the study and he/she is considered a Study 
Completer. If the PIVC was removed as a result of treatment completion (i.e., subject no 
longer requires a PIVC) he/she will be considered a Study Completer. In addition, if he/she 
was subsequently discharged from the facility, then he/she may re-enter the study in the same 
or different Stage if a re-admission for any reason is required. Subjects who participate in 
more than one stage, or more than once in a single stage, will be considered independent for 
all analyses. 
12.5 B. Braun Peripheral Advantage Program Nisit Compliance 
Any deviations from the protocol will be documented, evaluated and subsequently described 
in the final study report. A protocol amendment may be required depending on the nature of 
the deviation. 
12.6 Demographic and Baseline Characteristics 
Descriptive statistics will be used to summarize demographic/clinical experience information 
including age, gender, title/function, shift, and years of clinical experience for the RN 
population. Demographic information including age and gender will be collected from the 
subject population. No statistical testing to compare the two populations (RNs and Subjects) 
will be performed. 
Demographic and baseline information will be summarized in tables using descriptive 
statistics. 
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13 STUDY MANAGEMENT 
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The Investigator must conduct the study in accordance with the laws and regulations of the 
country in which the study is conducted and in accordance with the accepted version of the 
Declaration of Helsinki and/or all relevant federal regulations, as set forth in Parts 50, 56, 
312, Subpart D, of Title 21 of the Code of Federal Regulations (CFR), and in compliance 
with good clinical practice (GCP) guidelines. 
Conduct of the study must be approved by an appropriately constituted IRB. Approval is 
required for the study protocol, any protocol amendments, and ICFs. 
13.1 Informed Consent 
The Investigator or designee must explain to each subject participating in Stage 1 and Stage 4 
the nature of the study, its purpose, the procedures involved, the expected duration, the 
potential risks and benefits involved, and any discomfort it may entail. Each subject or 
his/her LAR (if appropriate) must be informed that participation in the study is voluntary, 
that he/she may withdraw or be withdrawn from the study at any time, and that withdrawal of 
consent will not affect his/her relationship with the treating physician. 
The informed consent should be given by means of a standard written statement, written in 
non-technical language. 
The subject or his/her LAR (if appropriate) should read and 
consider the statement before signing and dating it, and he/she should be given a copy of the 
signed document. No subject can enter Stage 1 and/or Stage 4 of the study or have any study 
related procedures performed before informed consent has been obtained from him/her or 
his/her LAR (if appropriate). A subject may participate in one or more of the 3 Stages that 
require patient care (Baseline, Run-In, or Post-Interventional). However, subjects must be 
consented for Stage 1 and/or Stage 4 of the study. In the event a subject re-enrolls in the 
study, he/she or his/her LAR (if appropriate) must sign another Informed Consent. 
The Investigator will provide B. Braun or its representative with a copy of the Institutional 
Review Board (IRB) approved ICF prior to the start of the study. 
13.2 Data Handling 
In the event a subject with a successful PIVC insertion drops out or is withdrawn from the 
study, B. Braun or its designee will be informed in a timely manner and the date and time of 
withdrawal will be recorded. In the event a subject has or was withdrawn from the study 
before a PIVC insertion attempt or a successful PIVC insertion by a Study RN, he/she will be 
considered as an Early Termination from the study. In the event a subject or his/her LAR 
(if appropriate) withdraws consent or the PI removes the subject from the study for any 
reason, the subject will be consider as an Early Withdrawal. In the event of a subject's 
withdrawal of consent or any other early withdrawal that also did not result in the IV being 
removed, the date and time of that withdrawal will be used as a surrogate for the date and 
time ofremoval of the IV and the subject's data will be treated in the same manner as a study 
completer. In this case, the subjects will not be allowed to re-enroll in the study. 
If the PIVC was removed for a complication, then the subject may not continue or re-enter 
into the study and he/she is consider a Study Completer. If the PIVC was removed as a result 
of treatment completions (i.e., subject no longer requires a PIVC) he/she will be considered a 
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Study Completer. In addition, if he/she was subsequently discharged from the facility, then 
he/she may re-enter the study in the same or different Stage if a re-admission for any reason 
is required. 
Any data to be recorded directly on the eCRFs (to be considered as source data) will be 
identified at the start of the study. Data reported on the eCRF that are derived from source 
documents should be consistent with the source documents, or the discrepancies must be 
explained. 
Clinical data will be entered on eCRFs for transmission to the Sponsor. Data on eCRFs 
transmitted via the web-based data system must correspond to and be supported by source 
documentation maintained at the study site, unless the study site makes direct data entry to 
the databases for which no other original or source documentation is maintained. In such 
cases, the study site should document which eCRFs are subject to direct data entry and 
should have in place procedures to obtain and retain copies of the information submitted by 
direct data entry (such as diaries). All study forms and records transmitted to the Sponsor 
must carry only coded identifiers such that personally identifying information is not 
transmitted. The primary method of data transmittal is via the secure, internet-based EDC 
system maintained by the Contract Research Organization. Access to the EDC system is 
available to authorized users via the study's Internet web site, where an assigned username 
and password are required for access. 
Any changes made to data after collection will be made through the use of electronic data 
clarification forms/queries. eCRFs will be considered complete when all missing and/or 
incorrect data have been resolved. 
13.3 Source Documents 
Source documents are considered to be all information in original records and certified 
copies of original records of clinical findings, observations, data or other activities m a 
clinical study necessary for the reconstruction and evaluation of the study. 
13.4 Recording of data 
Case Report Forms or eCRFs will be designed to identify each subject by a unique Subject 
Identification Number (SIN), B. Braun PA being evaluated, and the results observed. All 
entries to the eCRFs must be made according to appropriate SOPs. Data collected on eCRFs 
during the study will be documented in an anonymous fashion, and the subject will only be 
identified by the SIN. If, as an exception, it is necessary for safety or regulatory reasons to 
identify the subject, both B. Braun and the Investigator are bound to keep this information 
confidential. 
The Investigator must sign the designated page(s) of the eCRFs, thereby stating that he/she 
takes responsibility for the accuracy of the data in the entire eCRF. All records will be kept 
in conformance to applicable national laws and regulations. 
Any changes made to data after collection will be made through the use of electronic data 
clarification forms/queries. Case Report Forms/eCRFs will be considered complete when all 
missing and/or incorrect data have been resolved and or source verified. 
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The original signed ICF will be saved with each subject's file. When the study is completed, 
the ICF will be kept in the appropriate file folder; otherwise a note indicating where the 
records are located will be saved in the study file. 
13.5 Record Retention 
Study records and source documents will be maintained per Hospital policy and local 
regulations. 
The Investigator agrees to comply with all applicable federal, state, and local laws and 
regulations relating to the privacy of patient health information, including, but not limited to, 
the Standards for Individually Identifiable Health Information, 45 CFR, Parts 160 and 164 
( the Health Insurance Portability and Accountability Act of 1996 [HIP AA] Privacy 
Regulation). 
The Investigator shall ensure that study patients authorize the use and 
disclosure of protected health information in accordance with HIP AA Privacy Regulation 
and in a form satisfactory to the Sponsor. 
Storage of all source documents will be maintained for at least 2 years by the study site. 
Database management activities can be found in the Data Management Plan (DMP). 
13.6 Monitoring 
During the study, B. Braun (and/or designee) may visit the site regularly or remotely to 
evaluate the completeness of study records, the accuracy of entries on the eCRF, the 
adherence to the protocol and ICH-GCP guidelines, and the progress of enrollment, and to 
ensure that B. Braun PA is being stored, dispensed and accounted for according to 
specifications. Remote monitoring and/or source data verification will be performed if the 
site has imposed, or is subject to, travel and/or visit restrictions for in-person visits due to 
circumstances such as those related to the Covid-19 pandemic or if the monitor is subject to 
travel restrictions. Key study personnel will be available to assist the monitor during these 
visits. 
The data required by the protocol must be recorded on the appropriate eCRFs. The eCRFs 
and any source documents will be available to the study monitor who may perform a 100% 
source document verification ( comparison of the data recorded in the eCRF with those in the 
source documents). 
The eCRFs and source data will also be available for an audit by 
B. Braun or the FDA at any time. 
The Investigator will give the monitor access to relevant clinical records to confirm their 
consistency with the eCRF entries. No information in these records about the identity of the 
clinicians will leave the study center. Additional checks of the consistency of the source data 
with the eCRFs are performed according to the study-specific monitoring plan. 
13. 7 Quality Control and Quality Assurance 
The Sponsor or its designee will perform the quality assurance and quality control activities 
of this study; however, responsibility for the accuracy, completeness, and reliability of the 
study data presented to the Sponsor lies with the Investigator generating the data. 
The Sponsor may arrange audits as part of the implementation of quality assurance to ensure 
that the study is being conducted in compliance with the protocol, standard operating 
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procedures, GCP, and all applicable regulatory requirements. Audits will be independent of, 
and separate from, the routine monitoring and quality control functions. Quality assurance 
procedures will be performed at study sites and during data management to assure that safety 
and efficacy data are adequate and well documented. 
14 STUDY-SPECIFIC MATERIALS 
The Sponsor will supply B. Braun PA Program for this study which consists of the following 
items: 
1. PA Education Curriculum 
2. Christie Vein Viewer® Vision2 
3. Introcan Safety® IV Catheters 
4. STEADYCare™ Smallbore Extension Set 
15 PROTOCOL AMENDMENT AND PROTOCOL DEVIATION 
15.1 Protocol Amendment 
Changes to the protocol that entail corrections of typographical errors, clarifications of 
confusing wording, changes in study personnel, and minor modifications that have no impact 
on the safety of patients or the conduct of the study will be classed as administrative or 
non-substantial amendments and will be submitted to the IRBs for information only. 
B. Braun or its designee will ensure that acknowledgement is received and filed. 
Any changes or additions to this clinical study protocol that are classed as substantial 
amendments (having a direct impact on the safety, physical or mental integrity of the subject, 
or the scientific value of the trial, or the conduct or management of the trial, or the quality or 
safety of any study device used in the trial) requires a written protocol amendment that must 
first be approved by B. Braun unless there is a safety concern that requires immediate action. 
In the event a substantial amendment is required, B. Braun will make a determination if the 
Study will need to be put on hold until the amendment is approved. Amendments classed as 
substantial amendments must be submitted to the IRBs for approval. 
15.2 Protocol Deviations 
Deviations from the planned study conduct are not permitted. Should a protocol deviation 
occur, the Sponsor or its designee must be informed as soon as possible and the deviation 
must be documented in the Study File/Trial Master File and summarized in the final study 
report. Protocol deviations and the reasons they occurred will be included in the clinical 
study report. Reporting of protocol deviations to the IRB and in accordance with applicable 
FDA mandates is an Investigator responsibility. 
16 ETHICAL CONSIDERATIONS 
This study must be carried out in compliance with the protocol and in accordance with 
appropriate SOPs. These are designed to ensure adherence to GCP guidelines, as described 
m: 
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• 
ICH Harmonized Tripartite Guidelines for GCP 1996. Directive 91/507/European 
Ethics Committee (EEC), The Rules Governing Medicinal Products in the 
European Community. 
• 
US 21 Code of Federal Regulations (CFR) dealing with clinical studies (including 
parts 50 concerning informed consent regulations). 
• 
Declaration 
of 
Helsinki, 
concerning 
medical 
research 
in 
humans 
(Recommendations Guiding Physicians in Biomedical Research Involving Human 
Subjects, Helsinki 1964 and amendments). 
The Investigator agrees, when signing the protocol, to adhere to the instructions and 
procedures described in it and thereby to adhere to the principles of GCP that it conforms to. 
17 FINANCING AND INSURANCE 
Prior to the study commencing, the Sponsor or its designee and the Investigator ( or the 
institution, as applicable) will agree on costs necessary to perform the study. This agreement 
will be documented in a financial agreement that will be signed by the Investigator ( or the 
institution signatory) and the Sponsor or its designee. 
The Investigator is required to have adequate current insurance to cover claims for 
negligence and/or malpractice. The Sponsor will provide insurance coverage for the clinical 
study as required by national regulations. 
18 TERMINATION OR SUSPENSION OF STUDY 
Both B. Braun and the Investigator reserve the right to terminate or suspend the study at any 
time. If early study termination is necessary, study procedures will be completed on an 
individual subject basis after review and consultation by both B. Braun and the Investigator. 
In terminating the study, B. Braun and the Investigator will ensure that adequate 
consideration will be given regarding the protection of the subjects' interests. 
19 CONFIDENTIALITY AND PUBLICATION POLICIES 
19.1 Disclosure and confidentiality 
By signing the protocol, the Investigator agrees to keep all information provided by B. Braun 
in strict confidence and to request similar confidentiality from his/her staff Study documents 
provided by B. Braun or its designee (e.g., protocol, eCRFs and other material) will be stored 
appropriately to ensure their confidentiality. The information provided by B. Braun or its 
designee to the Investigator may not be disclosed to others without direct written 
authorization from B. Braun or its designee, except to the extent necessary to obtain informed 
consent from subjects or his/her LAR (if appropriate) who wish to participate in the study. 
19.2 Publication Policy 
Both the use of data and the publication policy are detailed within the clinical study 
agreement. Intellectual property rights ( and related matters) generated by the Investigator 
and others performing the clinical study will be subject to the terms of a clinical study 
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B. Braun Medical Inc. 
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agreement that will be agreed between the Institution and the Sponsor or its designee. With 
respect to such rights, the Sponsor will solely own all rights and interests in any materials, 
data, and intellectual property rights developed by Investigators and others performing the 
clinical study described in this protocol, subject to the terms of any such agreement. In order 
to facilitate such ownership, Investigators will be required to assign all such inventions either 
to their Institution or directly to the Sponsor or its designee, as will be set forth in the clinical 
study agreement. 
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REFERENCES 
US-N-H-1 801 
Final Protocol Amendment 1 
1. Abbas SZ, de Vries TK, Shaw S, Abbas SQ. Use and complications of peripheral 
vascular catheters: a prospective study. Br J Nurs 2007; 16:648-650, 652. 
2. Cicolini G, Manzoli L, Simonetti V, et al. Phlebitis risk varies by peripheral venous 
catheter site and increases after 96 hours: A large multi-centre prospective study. J 
Adv Nurs 2014;70: 2539-2549. 
3. Doellman D, Hadaway L, Bowe-Geddes LA, et al. Infiltration and extravasation: 
update on prevention and management. J Infus Nurs. 2009;32(5):309-313. 
4. Frey AM. Success rates for peripheral LV. insertion in a children's hospital. Financial 
implications. Journal of Intravenous Nursing, 1998; 21:160-165. 
5. Greig JM, Ellis CJ, Smith EG. Septic discitis and other complications of peripheral 
venous cannulation. QJM 2002;95(6):412-413. 
6. Hadaway L. Short peripheral intravenous catheters and infections. J Infus Nurs 
2012;35:230-240. 
7. Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but 
unacceptable: Peripheral IV catheter failure. J Infus Nurs. 2015;38(3):189-203. 
8. Hollenbeak CS. The cost of catheter-related bloodstream infections. J Infus Nurs. 
2012;34(5):309-313. 
9. Keleekai, N., Schuster, C.A., Murray, C.L., King, M.A., Stahl, B.R., Labrozzi, L.J., 
Gallucci, S., LeClair, M.W., & Glover, K.R. Improving nurses' peripheral 
intravenous catheter insertion knowledge, confidence and skills using a simulation-
based, blended learning program: a randomized trial. Simulation in Healthcare. 
2016;11, 376-384. 
10. Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infections in adults with 
different intravascular devices: a systematic review of 200 published prospective 
studies. Mayo Clin. Proc. 2006;81 (9): 1159-1171. 
11. McNeill EE, Hines NL, Phariss R. A clinical trial of a new all-in-one peripheral short 
catheter. JAVA. 2009; 14(1 ):46-51. 
12. Needlesticks. Medical Device Reporting Guidance for User Facilities, Manufacturers, 
and Importers. US. Department of Health and Human Services. Food and Drug 
Administration. Center for Devices and Radiological Healthy. November 12, 2002. 
13. O'Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the Prevention of 
Intravascular Catheter-Related Infections. Centers for Disease Control and 
Prevention. https://www.cdc.gov/mmwr/preview/mmwrhtm1/rr511 0al .htm. Updated 
July 29, 2002. Accessed February 23, 2018. 
14. Palefski SS, Stoddard GJ. The infusion nurse and patient complication rates of 
peripheral-short catheters. A prospective evaluation. J Intraven Nurs 2001 ;24:113-
123. 
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Peripheral Advantage Curriculum 
US-N-H-1 801 
Final Protocol Amendment 1 
15. Powell J, Tarnow KG, Perucca R. The relationship between peripheral intravenous 
catheter indwell time and the incidence of phlebitis. J Infus Nurs. 2008;31(1):39-45. 
16. Reznek, M.A., Rawn, C.L., Krummel, T.M. (2002 Evaluation of the educational 
effectiveness of a virtual reality intravenous insertion simulator. Academic 
Emergency Medicine. November, volume 9, Number 11, pp 1319-1325 
17. Rickard CM, Webster J, Wallis MC. Routine versus clinically indicated replacement 
of peripheral intravenous catheters: a randomized controlled equivalence trial. Lancet. 
2012;380(9847): 1066-1074. 
18. Royer T. Improving short peripheral IV outcomes: a clinical trial of two securement 
methods. JAVA. 2003;8(4). 
19. Schears GJ. Summary of product trials for 10,164 patients: comparing an intravenous 
stabilizing device to tape. J Infus Nurs. 2006;29( 4):225-231. 
20. Sheppard K, LeDesma M, Morris NL, O'Connor K. A prospective study of two 
intravenous catheter securement techniques in a skilled nursing facility. J Intraven 
Nurs. 1999;22(3):151-156. 
21. Smith JP. Thrombotic complications in intravenous access. J Intraven Nurs. 
1998;21(2):96-100. 
22. Vinograd M; Zorc JJ; Dean AJ; Abbadessa MKF; Chen AE. First-Attempt Success, 
Longevity, and Complication Rates of Ultrasound-Guided Peripheral Intravenous 
Catheters 
in 
Children. 
Pediatr 
Emerg 
Care. 
2017 
Feb 
18. 
doi: 
10.1097/PEC.0000000000001063. [Epub ahead of print]. 
23. Webster J, Clarke S, Paterson J, et al. Routine care of peripheral intravenous catheters 
versus clinically indicated replacement: 
randomized controlled trial. BMJ 
2008;337:1-6. 
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APPENDICES 
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Appendix 1: PIVC Insertion Confidence Assessment 
Peripheral Intravenous Catheter (PIVC) Insertion Confidence Assessment 
Protocol No. US-N-H-1801 
RN Identification 
Date 
-----------------
---------
This assessment is to be taken both BEFORE and AFTER training on B. Braun Peripheral 
Advantage Education Curriculum. 
g
one of the following. 
Stage 2 Pre-Training; 
Stage 2 Post-Training; 
Stage 4 End of Study 
1 =strongly disagree; 2=disagree; 
3=neither disagree nor agree; 
S=strongly agree 
4=agree; 
Using the scale above, please rate your agreement with each of the following statements: 
I am confident I can, 
Strongly disagree -
Strongly agree 
1) start an IV within 1 or 2 attempts. 
1 2 
3 
4 
5 
2) select the most appropriate catheter for the prescribed treatment plan. 1 2 
3 
4 5 
3) assist my peers with difficult IV starts. 
1 2 
3 
4 
5 
4) select an ideal site and vein for peripheral IV access using patient landmarks. 
1 2 
3 
4 
5 
5) prepare the insertion site. 
1 2 
3 
4 
5 
6) insert Catheter correctly. 
1 2 
3 
4 
5 
7) advance the IV catheter correctly. 
1 2 
3 
4 
5 
8) remove the needle/stylet with minimal blood exposure. 
1 2 
3 
4 
5 
9) stabilize the IV catheter. 
1 2 
3 
4 
5 
10) dress and secure the IV catheter and tubing. 
1 2 
3 
4 
5 
11) document my peripheral IV insertion. 
1 2 
3 
4 
5 
12) recognize and document the complications associated with a catheter. I 
2 
3 
4 5 
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Appendix 2: PIVC Knowledge Assessment 
PIVC Knowledge Assessment 
RN Identification 
Date 
-------------
--------
This assessment is to be taken both BEFORE and AFTER training on B. Braun Peripheral 
Advantage Education Curriculum. 
@
one of the following: 
Stage 2 Pre-Training; 
Stage 2 Post-Training; 
Stage 4 End of Study 
1. Identify the veins on the following images by writing the name of 
the vein in each of the blanks provided, select from the list of vein 
names below. 
Final 03 February 2021 
• Metacarpal 
• Dorsal venous 
arch 
• Median 
• Digital 
• Cephalic 
• Ancillary 
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2. Indicate whether the veins below are appropriate or not appropriate for routine 
peripheral IV catheter placement in the adult patient with an "A" or an "N" 
where: 
A = Appropriate 
N = Not appropriate 
___ Veins of the wrist 
___ Mid-forearm basilic vein 
___ Great saphenous vein 
___ Mid-forearm cephalic vein 
___ Veins in areas of joint flexure 
___ Antecubital fossa cephalic vein 
___ Veins without bifurcations 
___ Veins of the lower extremities 
3. What is the purpose of using a tourniquet in the process of placing a PIVC? 
a. To promote vascular distention in preparation for peripheral venipuncture 
b. To impair circulatory flow until peripheral IV catheter is placed 
c. To stabilize veins and prevent veins from rolling 
d. To distract from pain sensation 
4. Which peripheral IV complication is the result of inflammation of the vein? 
a. Phlebitis 
b. Infiltration 
c. Extravasation 
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d. Infection 
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5. Which peripheral IV complication is the result of a vesicant solution 
entering into tissue surrounding the vein? 
a. Phlebitis 
b. Infiltration 
c. Extravasation 
d. Infection 
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6. The peripheral IV complication commonly associated with swelling, 
blanching, coolness to touch and alteration in flow rate is: 
a. Phlebitis 
b. Infiltration 
c. Extravasation 
d. Infection 
7. Place the following venipuncture steps in correct order from start to finish. 
a. Occlude blood vessel 
b. Wash hands 
C. Remove stylet 
d. Thread catheter 
e. Release tourniquet 
f. 
Stabilize vein 
g. Connect to an IV administration set or saline lock 
h. Insert needle and catheter 
1. 
Don gloves 
8. During insertion, what does the presence of blood in the flashback chamber 
of a peripheral IV catheter indicate? 
a. The catheter is in the vein 
b. Both the catheter and the needle are in the vein 
c. The needle bevel has punctured the back wall of the vein 
d. The needle bevel has entered the vein 
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Peripheral Advantage Curriculum 
9. From the following examples, select the most appropriate documentation for a 
peripheral IV catheter insertion procedure? 
a. 
01/17/2014 
11:00 
b. 
C. 
d. 
22-Gauge peripheral IV Catheter placed in left arm per MD orders on 2
nd 
attempt. Flushed with 5ml 0.9% NS. Pt tolerated procedure well. No 
redness or swelling at site. Site dressed per protocol. 
V. Eni RN 
01/17/2014 11 :00 
22-Gauge 1 inch PIVC inserted into right cephalic vein, midpoint of forearm 
on first attempt. Flushed easily with 5ml 0.9% NS. Site without indication of 
complications. Dressed and secured per protocol. Patient states, "That 
wasn't bad." 
01/17/2014 11 :00 
20-Gauge 1-inch PIVC inserted into right mid forearm on first attempt. 
Patient understood procedure and tolerated well. Site without sign or 
symptom of complications. Dressed and secured per protocol. IV 
theraov initiated. 
01/17/2014 11 :00 
20-Gauge IV Catheter was placed in right metacarpal vein on 2
nd attempt. 
Flushed easily with 5ml 0.9% NS, saline lock in place. Patient states, "I 
have difficult veins, most nurses try 3 or4 times before getting it in." 
V. Eni RN 
10. During an attempt to insert an IV catheter, the patient expresses feeling an 
electric shock-like sensation down his arm, what is the most likely reason? 
a. Anxiety due to fear of needles 
b. The needle passed through the back wall of the vein 
c. Direct needle contact with the nerve 
d. Catheter shearing 
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For questions 11 throµ~h 13 refer to the followin~ scenario; 
Mrs. Smith is an 85 year old patient with pneumonia transferred to your unit, after 
spending 6 hours in the ED, for IV antibiotics and continuous IV fluids. The current IV 
is an 18g in the right lateral antecubital vein. Mrs. Smith complains of discomfort at the 
site, and the IV pump intermittently alarms occlusion. You assess that the site is red and 
tender to touch and determine that this current IV device and site has to be changed. 
11. Based on your assessment of the right antecubital access site, this would most 
likely be a sign of which complication? 
a. Infiltration 
b. Extravasation 
c. Phlebitis 
d. Infection 
12. After removal and dressing the right antecubital access site, the best nursing 
intervention care for this site would be to ... 
a. Apply cool compress and document intervention and assessment 
b. Apply a warm compress and document intervention and assessment 
c. Apply an arm splint and elevated extremity, document intervention and 
assessment 
d. Apply a topical antihistamine and notify physician of assessment 
13. From the list below select the most appropriate site and catheter 
combination to use for restarting the IV. 
a. Left mid-forearm vein; 22g, I-inch catheter 
b. Left median antecubital Vein; 20g, 1.25-inch catheter 
c. Vein in back of left hand; 18g, I-inch catheter 
d. Vein in back ofright hand; 22g, 1.5-inch catheter 
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14. As a general guideline, what type of IV catheter should be selected when 
considering routine peripheral venous access? 
a. The largest gauge and shortest length catheter the vein will accommodate to 
deliver prescribed therapy 
b. The largest gauge and longest length catheter the vein will accommodate to 
deliver prescribed therapy 
c. The smallest gauge and longest length catheter the vein will accommodate to 
deliver prescribed therapy 
d. The smallest gauge and shortest length catheter the vein will accommodate to 
deliver prescribed therapy 
LAST PAGE 
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