Peripherally Inserted Internal Jugular Catheters: an Observational Study
Phase: NA
Conditions: Intravenous Drug Usage
Sponsor: University of New Mexico

Peripheral Internal Jugular Catheters
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PROTOCOL TITLE:
Peripherally inserted internal jugular catheters: an observational study
PRINCIPAL INVESTIGATOR:
Tony Yen, MD
Anesthesiology Department
VERSION NUMBER:
1
DATE:
February 20, 2018
REGULATORY FRAMEWORK:
Please indicate all that apply:
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
HHS (Department of Health and Human Services)
VA
Other:      
Is this a clinical trial under ICH-GCP E6?   
 Yes   
 No
If yes, please confirm that the research team is familiar with and agrees to comply with 
the investigator requirements cited in ICH-GCP E6.  
 Yes   
 No 
ICH-GCP E6 can be accessed by copying and pasting this URL into your browser: 
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf

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Table of Contents
1.
Objectives.................................................................................................................................3
2.
Background ..............................................................................................................................3
3.
Study Design ............................................................................................................................5
4.
Inclusion and Exclusion Criteria ..............................................................................................5
5.
Number of Subjects..................................................................................................................6
6.
Study Timelines........................................................................................................................6
7.
Study Endpoints .......................................................................................................................6
8.
Research Setting.......................................................................................................................6
9.
Resources Available.................................................................................................................6
10.
Prior Approvals.....................................................................................................................7
11.
Multi-Site Research ..............................................................................................................7
12.
Study Procedures ..................................................................................................................7
13.
Data Analysis........................................................................................................................8
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects.........................................8
15.
Withdrawal of Subjects.........................................................................................................9
16.
Data Management/Confidentiality........................................................................................9
17.
Data and Specimen Banking...............................................................................................10
18.
Risks to Subjects.................................................................................................................10
19.
Potential Benefits to Subjects .............................................................................................10
20.
Recruitment Methods..........................................................................................................11
21.
Provisions to Protect the Privacy Interests of Subjects ......................................................11
22.
Economic Burden to Subjects.............................................................................................11
23.
Compensation .....................................................................................................................12
24.
Compensation for Research-Related Injury........................................................................12
25.
Consent Process..................................................................................................................12
26.
Documentation of Consent .................................................................................................13
27.
Study Test Results/Incidental Findings ..............................................................................13
28.
Sharing Study Progress or Results with Subjects...............................................................14
29.
Inclusion of Vulnerable Populations ..................................................................................14
30.
Community-Based Participatory Research.........................................................................14
31.
Research Involving American Indian/Native Populations .................................................14
32.
Transnational Research.......................................................................................................14
33.
Drugs or Devices ................................................................................................................14
Checklist Section ...........................................................................................................................14

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1. Objectives
1.1. This is an observational study intended to characterize the time-to-placement of 
peripherally-inserted internal jugular (PIJ) catheters in appropriate patients.  As 
secondary outcomes and to ensure participant safety, the investigators will record 
and evaluate adverse outcomes, but the study is not powered to detect rare 
adverse events.
1.2. As an observational study, there is not a specific hypothesis to test; rather this study is 
intended to estimate the time required to place PIJ catheters in appropriate patients.
2. Background
2.1. Gaining peripheral IV access is a routine part of anesthesia practice in patients 
undergoing surgical procedures. Adequate IV access allows for the infusion of induction 
agents, medications, fluids or blood products throughout the perioperative course. Often 
in practice, we encounter patients in which peripheral access may be difficult to obtain. 
The use of ultrasound guided insertion is a common method to assist in placement of a 
peripheral IV in these difficult to access patients. Reasons for difficult access include 
those who are obese, IV drug abusers, dark skinned, or dehydrated. In addition to the 
initial IV, placement of a second IV after induction is occasionally necessary for the 
infusion of additional fluids or mediations as well as providing an alternate line in the 
event of failure of the first IV. When placement of a catheter is difficult, alternative 
methods have been established for gaining IV access, including cannulation of the EJ 
(external jugular vein), or the deep brachial or basilic veins under ultrasound guidance. 
In addition to these methods, recent studies have proposed a technique of placing a 
peripheral catheter directly into the internal jugular vein under ultrasound guidance.  
What is unique about this method is the use of a regular angiocatheter, not a central 
venous line, and that it is for temporary usage for situations when peripheral access is 
difficult to obtain.
2.2. The investigators have not gathered preliminary data on this topic.
2.3. Several studies have demonstrated this technique, mainly in Emergency 
Department and ICU patients. One case series of 9 patients describes placing a 
peripheral IJ in those with unobtainable IV access [1]. 64 mm angiocatheters 
were used to cannulate the IJ under ultrasound guidance. All catheters were 
labeled for removal within 72 hours and all patients were followed up via chart 
review one year later. Two of 9 catheters failed due to kinking within the first 48 
hrs. There were no apparent adverse outcomes in any patient including deep vein 
thrombosis, bacteremia, endocarditis or pneumothorax. 
A second prospective case series studied 9 patients who had placement of a 
peripheral-IJ, when other access could not be obtained and the patient did not initially 
require a central line [2]. Follow-up with all patients was attempted within a week. 
On follow-up, the seven patients who were successfully contacted denied any fevers, 
chills, swelling or pain at the site of catheter entry.

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In a multicenter, non-comparative trial at a resident affiliated hospital and 2 tertiary 
care urban academic centers, 83 attempts were made in 74 patients with high 
frequency ultrasound probe [3]. The patients performed Valsalva and an 18g 4.5 cm 
catheter was placed.  Catheters remained in place at a maximum of 24 hours. Initial 
success rate was 88% and the mean procedure time was 4.4 min (range 1-10.5 mins). 
Line infection and complications were evaluated by home contact after discharge 
with no reports of pneumothorax, line infection, or arterial puncture. 
Another prospective observational study was performed on consecutive patients 
admitted to ICU or medical ward with difficult IV access [4]. A 2.5in 18g catheter 
was placed. 20 catheters were placed in 19 patients (one patient had one catheter 
exchanged for another after 7 days). 16 were placed on the 1st attempt and the 
remaining 4 were placed successfully on the 2nd attempt. Average time to place was 
5.3 mins (2-10 mins). There were no signs of fever, neck pain/stiffness, or hematoma 
on follow up.  There were no immediate complications noticed.
A Prospective convenience study was conducted in 2 urban academic centers in 33 
patients.  High frequency linear ultrasound probe was used along with two types of 
catheters 18g 6.36 cm (2.5 in) catheter and a 20g 5.7 cm (2.2 in.) catheter]. Median 
time to placement was 4 minutes. There were no immediate complications observed 
nor was there any evidence or clinical suspicion for complication of line placement at 
6 week follow up. One patient had a positive blood culture for Staph Aureus at 1 
week follow up but this patient was admitted for sepsis.
To our knowledge, there are no studies in which cannulation of the internal jugular 
vein under ultrasound guidance has been performed by anesthesia providers in 
patients undergoing a surgical procedure. All the abovementioned studies reviewed 
showed that this was a relatively easy and quick procedure that resulted in no major 
complications. This is a safe and feasible option that can be performed quickly in 
patients that require large IV access but in whom IV access is difficult to obtain. 
References:
1. Zwank, M. D. (2012). Ultrasound-guided catheter-over-needle internal jugular vein 
catheterization. The American journal of emergency medicine, 30(2), 372-373. 
2. Teismann, N. A., Knight, R. S., Rehrer, M., Shah, S., Nagdev, A., & Stone, M. 
(2013). The ultrasound-guided “peripheral IJ”: internal jugular vein catheterization 
using a standard intravenous catheter. The Journal of emergency medicine, 44(1), 
150-154.
3.Moayedi S et al. Safety and Efficacy of the “Easy Internal Jugular (IJ)”: An 
Approach to Difficult Intravenous Access. J Emerg Med 51(6): 636 – 642. PMID: 
27658558

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4.Butterfield M et al. Using Ultrasound-Guided Peripheral Catheterization of the 
Internal Jugular Vein in Patients with Difficult Peripheral Access. Am J Ther 2015. 
PMID 26469683
5. Kiefer D et al. Prospective evaluation of ultrasound-guided short catheter placement in 
internal jugular veins of difficult venous access patients. Am J Emerg Med 2016; 34(3): 571 
– 81. PMID: 26776533.
3. Study Design
3.1. This is an observational study with one arm.  All enrolled patients will receive a 
peripheral angiocatheter in the internal jugular vein. As this is a single-arm study, 
blinding is not applicable.
4. Inclusion and Exclusion Criteria
4.1. Recruitment will occur among adult (age >18 years) elective-surgery patients, who do 
not require central venous catheters, in the UNMH operating rooms.
4.2. There are two potential inclusion criteria among these elective surgery patients; Patients 
who:

require a second intravenous access line (IV) as determined by the anesthesiologist, 
or 

require a primary IV and are determined by the anesthesiologist to have difficult IV 
access, defined as two or more failed attempts at peripheral IV placement, in the 
absence (as noted above) of an indication for a central venous catheter.
4.3. Exclusion criteria:

Infection over the intended peripheral angiocatheter insertion site

Cervical spine injury or instability

Known abnormal neck anatomy

Pregnancy

Prisoners

Clinical indication for central venous catheter

Any pre-existing suspicion for bacteremia
4.4. Adults unable to consent (as determined by ability to provide consent for surgery), 
minors, pregnant women, and prisoners will not be approached for enrollment.
4.5. Minors are being excluded from participation because the study will occur at the UNMH 
Main operating rooms rather than at UNM Children’s Hospital, and children are only 
brought to the main OR in unusual circumstances.  This exclusion will also serve to 
eliminate variation in the primary outcome caused by pediatric patients’ small physical 
size and distinct anesthetic management.

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5. Number of Subjects
5.1. This is a single-site study, and the investigators plan to enroll approximately 60 subjects, 
but no more than 70.
5.2. A sample of approximately 60 subjects will allow the investigators to estimate the true 
population mean procedure duration to within approximately ±0.25 sample standard 
deviations from the sample mean, with 95% confidence.  
6. Study Timelines
6.1. Describe:

The PIJ catheter will remain in place as clinically indicated during and immediately 
after surgery.  It is intended for temporary use.  Data collection on a given participant 
(in the form of medical chart review) will continue for events occurring up to one 
week after surgery in order to capture any complications that were not immediately 
observable.

Investigators anticipate that approximately one year will be sufficient to enroll the 
planned sample size.

Study completion is expected to take approximately one year after enrollment is 
complete.
7. Study Endpoints
7.1. The primary outcome is the time required to prepare and place a PIJ catheter.  Secondary 
outcomes include: location of insertion, depth of insertion, number of attempts, and 
complications (e.g. hematoma, pneumothorax, carotid punctures, thrombosis, insertion 
site infection) that are related to PIJ placement, in the opinion of the investigators.
7.2. Investigators will stop the placement procedure and remove the PIJ at any time that they 
believe doing so would be in the patient’s interest, e.g. carotid puncture.  Placement will 
be abandoned and alternative means of IV access will be attempted if the third attempt to 
place the PIJ is unsuccessful, or earlier if the clinician performing the procedure finds a 
clinical reason to do so. 
8. Research Setting
8.1. The research will be conducted in the main surgical suites of UNM Hospital, and in 
appropriate areas for authorized access to the patient EMR (electronic medical record).
8.2. Potential subjects will be identified and recruited from among investigators’ regular 
patients at the UNM surgical suites, in pre-operative holding areas.
8.3. All research procedures will occur in the UNM surgical suites.
9. Resources Available
9.1. PI Tony Yen MD is a board-certified anesthesiologist, and Associate Professor at UNM.  
Investigators Sean Morgan MD and Lia Hoffner MD are resident physicians in the 
Anesthesiology department at UNM.  Investigator Tim Petersen PhD is a Research 
Information Specialist in the Anesthesiology department at UNM, with extensive 

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experience in study design, analysis, and reporting.  All research procedures will be 
performed by personnel who have appropriate training, experience, and authorization.  
9.2. All clinical decisions will be made by appropriate providers who are duly authorized and 
credentialed to do so.
9.3. Other resources:

UNM’s operating rooms handle a high caseload, and the investigators anticipate little 
difficulty in recruiting 60 relevant patients from among them in one calendar year.

Engagement in research activities is an expected part of all investigators’ job duties, 
so conducting this study is not anticipated to conflict with their clinical, scientific, or 
administrative duties.

The UNM surgical suites are equipped with the personnel, supplies, and equipment 
necessary to respond to any eventuality that may arise as a result of participation in 
this study.

A copy of the HRRC-approved protocol will be distributed among the investigators 
prior to commencement of any research activities.  All investigators work in the same 
department, so communication among them is already routine.
10.Prior Approvals
10.1. The completed Departmental Review Form is included with the initial application for 
review of this protocol.
10.2. This study does not involve ionizing radiation, biological specimens, or administration 
of particular drugs.
11.Multi-Site Research
11.1. This is not a multicenter study.
12.Study Procedures 
12.1.
After recruitment and consent, a resident or attending physician in the Department 
of Anesthesiology who is an investigator in this study will place the PIJ catheters for this 
study, under ultrasound guidance.  Clean technique similar to that used for traditional 
peripheral intravenous catheters will be used, including chlorhexidine prep, caps, and 
sterile ultrasound gel with sterile occlusive bandage over the ultrasound transducer.  For 
patients included in this study because of a clinically-determined need for a second IV 
line, the catheter will be placed after anesthesia induction.  Patients included because of 
difficult IV access will have the PIJ catheter placed prior to induction.
The size of the angiocatheter will be left to the clinical discretion of the placing 
anesthesiologist, from among these choices: 18 G x 2.5 inches, 16 G x 2 inches, or 14 G x 
2 inches.  All angiocatheters will be radiopaque in order to permit visualization in the 
event of any required imaging.  Catheters will be placed with visualization under 
dynamic ultrasonography using a Sonosite S-nerve ultrasound machine with 13-6 MHz 
25mm linear array.  All catheters and ultrasound components are being used in 
accordance with their labeling.

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The depth of catheter insertion into the internal jugular vein will be determined, and the 
catheter will be removed/replaced immediately if it is found to extend less than 1.0 cm 
into the vessel.  If the catheter is removed or replaced, routine care will be followed: 
pressure will be held until bleeding subsides and the site dressed appropriately (e.g. gauze 
with tape or adhesive bandage).  No more than three attempts will be made before 
abandoning the effort to place a PIJ catheter.
The PIJ catheter will be secured as per normal practice, with an adhesive IV securing 
device and an occlusive bandage placed over both the IV and its securing device.
The PIJ catheter will be used as usual during surgery; as a means to administer 
vasopressor medications, transfusions, and other medications necessary for intraoperative 
anesthesia management.  It will not be used for total parenteral nutrition (TPN) or other 
continuous nutrient infusions.
In most cases, the PIJ catheter will be removed as usual before the patient is transferred 
to the floor, intensive care unit, or discharged home.  In some cases, however, an 
appropriately authorized clinician may determine that the PIJ line should stay in place 
longer, such as when no other intravenous access is available, or when a patient’s 
hemodynamic status requires active pressor administration.  If extended use of the PIJ 
line is indicated, it will be removed when it is either replaced by a means of intravenous 
access (e.g. routine IV or sterilely-placed central catheter) appropriate to the patient’s 
condition, or when IV access is no longer needed.
Procedural data will be collected on the day of surgery, and chart review will occur after 
surgery in order to capture any IV-related complications within the first week that were 
not immediately apparent.  The data sheet is included with this application.
13.Data Analysis
13.1. As this is an observational study intended to provide initial characterization of the time 
to place PIJ lines and a rough estimate of complication rates, data analysis will focus on 
traditional summary statistics; e.g. mean or median, as well as standard deviation or 
interquartile range as appropriate depending on distribution normality, and percentages 
for categorical data.
13.2. As noted in section 5.2 above, a sample of approximately 60 patients will permit the 
investigators to estimate the true population mean for the primary outcome to within 
approximately ±0.25 standard deviations from the mean, with 95% confidence.
14.Provisions to Monitor the Data to Ensure the Safety of Subjects
This section is required when research involves more than Minimal Risk to subjects. Describe:
14.1. The PI will perform data and safety monitoring.
14.2. The PI will review the collected data, which already includes relevant safety outcomes.  
The PI will refer to the EMR as appropriate to obtain relevant context on any adverse 
events.
14.3. The PI will conduct one interim review of the secondary outcomes after data collection 
is complete for approximately 30 patients.

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14.4. Intravenous catheters are in widespread use, as are the related but more invasive central 
access catheter and peripherally-inserted central catheter, and their safety profiles are 
well established.  It is not anticipated that the medical literature will report new 
findings that call the safety of this study into question.
14.5. The PI will review the incidence of adverse events related to PIJ use in this study to 
determine whether they exceed the incidence that would be expected with the use of 
more typical IV locations.
14.6. The PI will terminate the study in the event of any morbidity/mortality that is both 
significant and likely due to the procedure under investigation, in the PI’s opinion.
14.7. The PI will notify HRRC in the event of study termination under 14.6 above.
15.Withdrawal of Subjects
15.1. The investigators have not identified any circumstances under which a participant may 
be withdrawn from the research without their consent.
15.2. Withdrawal may be completed safely by simply removing the PIJ line as in normal 
procedures and ceasing data collection.
15.3. Partial withdrawal may be relevant for patients enrolled due to difficult IV access, as 
their placement procedure will be completed prior to anesthesia induction.  Despite 
providing informed consent, participants may change their minds about needle 
placement in the neck/shoulder area once the procedure begins.  Partial withdrawal will 
be offered in these cases, where the needle may have been inserted, so as to permit 
continued data collection of any adverse events.
15.4. If a patient elects to fully withdraw, data collection will cease, but existing data will be 
maintained.
15.5. The consent document contains information about withdrawal procedures and 
limitations.
16.Data Management/Confidentiality
16.1. Most members of the research team are physicians who interact with these and 
similarly-situated patients on a daily basis.
16.2. The research does require the use of direct identifiers (e.g. MRN) in order to accurately 
obtain complication data and link it to procedural data.
16.3. The research requires the use of Private Health Information (PHI), but the investigators 
will not disclose any identifiable information except as required by law.
16.4. The data do not include information that is typically considered to be sensitive, such as 
HIV status, substance abuse, or criminal behavior.
16.5. The investigators do not plan to pursue a Certificate of Confidentiality.
16.6. All investigators have completed routine UNM Health Sciences Center (HSC) training 
on the secure management and use of patient data.  Identifiable data on paper forms 
will be maintained in a locked cabinet in a restricted area, and in electronic format will 
be stored on HSC secure servers, which are password-protected.

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16.7. The investigators do not plan to code data.  Data will be deidentified upon completion 
of data collection and entry into a spreadsheet stored on UNM HSC secure servers, but 
will be identifiable until that point in order to permit accurate linkage of procedural and 
outcome data.
16.8. Any questionable entries in the paper data sheets will be verified by reference to the 
EMR, as appropriate.  
16.9. Identifiable data will not be transmitted to outside entities, except as required by law.
16.10.
Identifiable data will not be collected or transported by the internet; only on UNM 
HSC secure servers.
16.11.
Study records will be maintained for 3 years after closure as required by federal 
regulations.
16.12. Photographs and recordings of audio/video will not be used.
17.Data and Specimen Banking
17.1. Identifiable data will not be banked, but the investigators may maintain deidentified 
data indefinitely for related purposes, such as for power analyses in future projects. 
18.Risks to Subjects
18.1. All research involves risks of loss of confidentiality, inconvenience, stress, and 
emotional upset.  All participants are drawn from a population that requires alternate or 
enhanced IV access for clinical reasons.  This research does not modify the risks of IV 
access in general.  These risks include bleeding, infection, and blood clots.  Because of 
its use of the internal jugular vein, this research poses rare risks of carotid artery 
puncture and pneumothorax.
18.2. IV placement is a routine part of medical care, and the relevant anatomy is very well-
known, so it is extremely unlikely that this research would present unforeseen risks.
18.3. Pregnancy is an exclusion criterion, so risks to fetuses are not relevant in this study.
18.4. Some participants would already receive PIJ catheters due to difficult IV placement in 
other locations.  The investigators are taking steps to minimize the likelihood and 
severity of risks.  PIJ placement will be conducted under ultrasound guidance to permit 
real-time visualization of the needle as well as relevant anatomical structures.  In 
addition, the placement will be performed with clean technique involving chlorhexidine 
(or equivalent) prep, caps, sterile ultrasound gel, and sterile occlusive bandage over the 
ultrasound transducer.  The investigators have chosen an angiocatheter length that 
allows secure placement without undue risk of inadvertently “reaching” inappropriate 
anatomical structures.  Any catheter placed less than 1.0 cm into the vessel will be 
removed.  The protocol stipulates that total parenteral nutrition (TPN) or other 
continuous nutrient infusions will not be administered through the PIJ catheter.  
Routine catheter securing and occlusive bandage will be used, and the catheter will be 
removed prior to transfer to floor/ICU/discharge unless there is a clinical reason why it 
should temporarily remain, in the judgment of an investigator.  Finally, application of 
the inclusion/exclusion criteria will help to reduce risks, as they were chosen primarily 
for reasons of patient safety.

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19.Potential Benefits to Subjects
19.1. Subjects may benefit in several ways, although any benefits are mitigated as noted in 
section 19.2 below.  For patients included because of difficult IV access, the internal 
jugular vein offers a larger (and thus likely easier to place) and more reliable location 
for this access.  For patients in whom a second IV line is indicated, the use of the PIJ 
may permit increased catheter gauge, and thus increased rate of administration of 
relevant fluids in unexpected emergency situations.  Application of the 
inclusion/exclusion criteria is likely to result in a patient sample in whom discomfort 
related to multiple unsuccessful IV attempts may be reduced, as well as overall 
placement time, which would reduce the time spent under anesthesia.
19.2. These benefits are mitigated to some extent because all participants are drawn from a 
population that already requires enhanced IV access, either in the form of a second IV 
line or an alternative placement site in the case of difficult access at more traditional 
sites.  Patients who meet the inclusion/exclusion criteria but who do not participate in 
this study will still receive enhanced IV access, and some of them may receive IV 
placement in the internal jugular vein regardless of participation.
20.Recruitment Methods
20.1. Potential subjects will be recruited from among UNM Hospital surgical patients, who 
are regular patients of the investigators, in the pre-operative holding areas during the 
routine pre-surgical consultation between the anesthesia provider and patient.  An 
investigator will first ask whether the patient is interested in participating in research 
about IV placement.  If the patient expresses interest, the study will be explained in 
more detail and the consent process will commence.
20.2. Clinician investigators already review patients’ charts prior to surgery.  Patient 
characteristics in the inclusion/exclusion criteria are already considered as part of this 
routine review.
20.3. Recruitment will be verbal only; no advertisements will be used.
21.Provisions to Protect the Privacy Interests of Subjects
21.1. Recruitment will occur in the pre-operative holding areas, which are already 
sufficiently private for confidential doctor/patient conversations.  Recruitment will be 
handled by clinicians already authorized and expected to make contact with relevant 
patients.  Recruitment and consent will not require the disclosure of information 
beyond routine medical information.  The patient experience will not be greatly 
modified by participation in this study; the only change is the specified location of the 
IV, in a sample of patients who may already receive an IV in this location.  Similarly, 
participants will not be observed by atypical personnel.
22.Economic Burden to Subjects
22.1. Patients (or their 3rd-party payers) will be responsible for the cost of PIJ placement.  
However, this cost is negligible, because all participants are drawn from a population 
who already requires IV placement, and all supplies used in this study are the same as 

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in routine IV placement.   The investigators do not anticipate any change to patient cost 
as a result of participation in this study. 
Responsible Party
Research Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
PIJ placement
All
     
     
     
     
     
     
     
     
     
     
     
     
     
     
Responsible Party
Standard of Care Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Surgery
All
Anesthesia
All
Hospitalization (as appropriate)
All
Medications and supplies
All
     
     
     
     
     
     
     
     
22.2. Patients (or third-party payers) will be responsible for any costs related to adverse 
outcomes; this is discussed in the consent form.
23.Compensation
23.1. Participants will not be compensated.
24.Compensation for Research-Related Injury
24.1. Subjects will be responsible for any costs of research-related injury.  This is 
communicated in the consent documentation.
25.Consent Process
25.1. Consent will be obtained prior to research-related intravenous access.
25.1.1. An investigator will obtain consent.  All investigators have completed appropriate 
HIPAA, CITI, and related training as required by UNM HSC and by HRRC.
25.1.2. The consent process will take place in the pre-operative holding areas 
immediately after recruitment.  These areas are sufficiently private for 
confidential doctor-patient conversations. 
25.1.3. The possibility of coercion or undue influence is reduced in several ways.  All 
participants are drawn from a population that already requires alternative or 
enhanced IV access (either a second line, or an alternative placement when 
routine placement is difficult), and this study simply specifies the location of this 
enhanced/alternate access, so the benefits of participation are mitigated.  There is 

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no compensation for participation.  All prospective participants will be assured 
that there is no consequence for declining participation; participation is strictly 
voluntary.
25.1.4. Participation in this study only entails specification of an IV placement site, in the 
context of patients for whom more routine locations may not be suitable, and who 
may receive PIJ placement regardless of participation.  The consent decision is thus 
comparably complex to the decisions surrounding anesthesia management that are 
already routinely handled entirely within the preoperative anesthesia consultation.  
The appropriateness of day-of-surgery consent for anesthesia studies has also been 
the topic of scientific investigation, and the results clearly indicated that longer 
intervals in which to consider participation do not automatically benefit participants.  
This recent study (Murphy et al., “Consent for Anesthesia Clinical Trials on the Day 
of Surgery,” Anesthesiology 2016; 124:1246-55) showed that patients approached 
for consent to participate in anesthesia-related research on the day of surgery tend to 
be satisfied with the consent process, feel that the protocol was well explained and 
comprehended, and that the setting was appropriate.  Conversely, these patients 
strongly disagreed that they were anxious at the time of consent, felt obligated to 
participate, or regretted participating.  Importantly, the use of a preadmission 
telephone call to describe the research protocol and provide extended time for 
patients to consider their participation did not change these results.
25.1.5. Investigators do not anticipate that ongoing consent will be at issue during this 
study, because patients’ active participation (i.e. having the IV line in place) is 
relatively brief.
25.1.6. Consenting investigators will ask prospective participants to describe the study 
briefly in their own words in order to ensure understanding.
25.1.7. Subjects will be given a copy of the signed consent.
Subjects not fluent in English
25.1.8. The investigators do not anticipate enrollment of patients who do not speak 
English.  A majority of UNM Hospital surgical patients do speak English, so 
relatively few patients with insufficient English fluency to understand the consent 
materials would be encountered during the enrollment period.  
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally Authorized 
Representative
25.1.9. Patients in this category will not be enrolled.
Subjects who are not yet adults (infants, children, teenagers)
25.1.10. Minors will not be enrolled.
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of consent 
will be altered) 

The investigators are not seeking waiver or alteration of the consent process.

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26.Documentation of Consent
26.1. A proposed consent form is included with this application.
27.Study Test Results/Incidental Findings
27.1. Individual Results: This study does not involve laboratory tests or other findings 
outside routine medical care.  Relevant routine information is already shared with 
patients as appropriate, and this study does not change the delivery of information to 
patients.
27.2. Incidental Findings: The investigators do not anticipate any incidental findings to be 
generated by this study. 
28.Sharing Study Progress or Results with Subjects
28.1. Investigators do not plan to share in-progress study results with patients.
28.2. Investigators do not plan to share final study results with patients, because the data will 
be deidentified before the final analysis.
29.Inclusion of Vulnerable Populations
29.1. This research does not target any of the populations typically identified as vulnerable.
29.1.1. The research does not target UNM students or employees, but such persons 
may be incidentally involved.  As with other prospective participants, these 
patients will be assured that the participation decision has no bearing outside 
the immediate treatment context.
29.1.2. The research does not target economically disadvantaged persons, but the lack 
of compensation should mitigate any questions about coercion of this group, 
and the recruitment and consent processes should ensure understanding.
29.1.3. The research does not focus on seriously or terminally ill patients.
29.1.4. Pregnancy is an exclusion criterion, and the study does not involve any 
neonates.
29.1.5. The research does not involve prisoners.
29.1.6. The research does not involve minors or cognitively impaired adults.
30.Community-Based Participatory Research
NA.
31.Research Involving American Indian/Native Populations
31.1. NA.
32.Transnational Research
32.1. NA.
33.Drugs or Devices

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33.1. The research does not involve drugs.  It does not specify device selection, but the 
Device Checklist is completed below.
Checklist Section
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research.
I.
Waivers or Alterations of Consent, Assent, and HIPAA Authorization
Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will 
review to identify potential subjects and/or determine eligibility include Protected 
Health Information (PHI).
1. Will you be recording any PHI when conducting the records review to identify 
potential subjects and/or determine eligibility?
 Yes. Describe:      
 No
2. If you answered “Yes” to question 6 above, please describe when you will 
destroy identifiers (must be the earliest opportunity consistent with the 
conduct of the research) or provide justification for why they must be 
retained:
     
3. The PHI accessed or recorded for identification/screening purposes will not be 
reused or disclosed to (shared with) any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under 
the Privacy Rule.
 True
 False
II. Vulnerable Populations
A. Adults with Cognitive Impairments
NA.
B. Children
NA.

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C. Pregnant Women and Fetuses
NA.
D. Neonates of Uncertain Viability or Nonviable Neonates
NA.
E. Nonviable Neonates
NA.
F. Biomedical and Behavioral Research Involving Prisoners
NA.
III.Medical Devices
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  
If more than one medical device is being evaluated, provide the requested information for each.
A. Device Name:  This study does not specify any particular angiocatheter, except as to 
length/gauge and that it be radiopaque in case of any required imaging.  The investigators 
believe that this is not a device study per se, since all relevant patients would already receive 
one or more IV placements with any of a variety of related IV catheters, and the catheter is 
not specified.  This is simply a study of one particular anatomical location for IV placement.  
All catheters are being used in accordance with their labeling.
B. Manufacturer:  Not specified.
C. Does the research involve a Significant Risk Device under an IDE?
 Yes. Include documentation of the FDA approval of the IDE with your submission.  
Acceptable methods of documentation include: (1) FDA letter noting IDE number 
and approval status; (2) Industry sponsor letter noting IDE number and FDA 
approval status; or (3) FDA-approved industry sponsor protocol with IDE number 
noted 
 No
D. Is the research IDE-exempt?
 Yes. Include a FDA letter with your submission noting the determination that the 
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator) 
justifying why they believe the research is IDE-exempt*.  
 No
E. Does the research involve a Non-Significant Risk (NSR) Device?
 Yes. Include a FDA letter with your submission noting the determination that the 
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying why 
they believe the research is NSR**.  

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 No
* This FDA guidance includes a description for when a device study is exempt from the 
IDE requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf 
**This FDA guidance includes information on how to differentiate between Significant 
Risk and Non-Significant Risk device studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf