Standard vs Long IV Catheter Long-Term IV Survival Comparison
Phase: NA
Conditions: Catheter Complications
Sponsor: Corewell Health East

Study Protocol and Statistical Analysis Plan 
 
 
 
Study title: Standard vs Long IV Catheter Long-Term IV Survival Comparison   
 
NCT number: NCT03655106 
 
Document date: Mar 19, 2019 
 

Catheter length and IV Survival: Standard vs Long IV Catheter Long-Term 
IV Survival Comparison  
 
 
Background/Scientific Rationale: 
 
Patients with poor intravenous (IV) access present a daily challenge to emergency department 
(ED) practitioners. Placement of an ultrasound (US)-guided peripheral IV catheter in this patient 
population is a viable and safe option. Successful cannulation with US-guided IV occurs in more 
than 90% of cases compared with 25-35% with traditional IV placement in patients with difficult 
vascular access.1-3 Once cannulated, however, the failure rate of IV catheters placed under 
ultrasound guidance is concerning compared with traditional blind IV placement. Overall failure 
rates after successful IV cannulation for US-guided IVs is 45-56% when compared to traditional 
IV placement which is 19-25%.4-8 
 
Nearly all hospitalized patients need IV access for treatment. If access is lost, patients may 
experience treatment delays, dissatisfaction from repeat needle-sticks, and health complications 
if the patient’s condition becomes critical.  IV failure can result in a number of negative 
outcomes including interrupted medical therapy; painful phlebitis and reinsertions; increased 
hospital length of stay, morbidity and mortality from infections and/or skin necrosis from caustic 
medication infiltration; utilization of invasive procedures such as peripherally inserted central 
catheters (PICC) and central lines; and wasted medical/nursing time.9 
 
Ultrasound-guided IVs are often the last recourse for IV access before resorting to more invasive 
procedures in patients with difficult access.  Because failure rate is high, it is important to 
approach insertions methodically to improve survival rates. There are several characteristics of 
US-guided IV placement that have shown to increase catheter survival.  Anatomic variations 
shown to increase US-guided IV longevity include placing catheters more distally in the arms 
and in veins that are shallow.10  Another study determined that using a catheter over a guide-wire 
improves catheter longevity.7 However, these catheters are costly, are not readily available 
within most EDs, and may require sterile technique.  
 
A variable that may alter the survival of US-guided IVs that has not been studied extensively is 
the length of catheter that resides in the vein.  Currently the general accepted rule is that an 
“adequate” amount of the catheter should be in the vein to avoid failure of the catheter.11-14  
However, this recommendation is only anecdotal and there has been no study to verify or 
quantify it. Our preliminary data focused on defining this relationship. In our study, 100% of 
catheters failed in which less than 30% of the catheter was placed within the vein and no 
failures in those IVs in which at least 65% of the catheter was in the vein. All catheters in this 
analysis were commonly available 4.78 cm IVs. A key challenge for inserters is that achieving 
this quantity of catheter length in vein is impractical at the recommended angle of insertion when 
considering deeper target vessels. For many institutions, including ours, the 4.78 option is the 
longest stocked IV catheter and catheter survival is negatively impacted.  
 
 
 
Central Hypothesis/Objectives: 

 
We hypothesize that using an Ultra Long IV (6.35 cm) catheter increases the likelihood of 
ensuring a higher quantity of the catheter in the vessel lumen and leads to improved catheter 
longevity.  
 
Primary Objective: Compare the IV survival between the Ultra Long IV (UL IV) (6.35 cm/20G) 
and the Standard Long IV (SL IV) (4.78 cm/20G) placed under US-guidance. 
 
Function is defined as ability of catheter to flush 5 mL without resistance with or without blood 
sampling. 
 
Secondary/Tertiary Objective(s):  
 
Determine catheter survival based on vein depth.  
 
Determine optimal cutoff length of catheter in vein for best survival profile. 
 
Determine catheter survival based on angle of insertion.  
 
Quantify specific etiologies related to premature catheter failure comparing UL IV to the SL IV. 
 
Quantify overall costs associated with placement of the UL IV compared to the SL IV.  
 
Determine overall success of placement UL IV versus SL IV. 
 
Determine first-stick success UL IV compared to SLIV. 
 
Determine number of attempts and time to insertion comparing UL IV to SL IV. 
 
Safety Endpoint(s): 
 
Compare phlebitis and thrombosis complication rates between the Ultra Long IV and the 
Standard Long IV.  
 
Compare infection rates for all catheters.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Design:   
 
We propose a prospective, single-site, parallel, two-arm randomized investigation of catheter 
survival when two catheter lengths are evaluated. Specifically, experimental ultra long IV (6.35 
cm/20G) will be compared with conventional standard long IV (4.78 cm/20G). The primary 
objective of this study is to demonstrate that there is better IV survival when the quantity of 
catheter residing in the vein is enhanced. Patients with functional catheters less than 24 hours 
duration and discharged will be excluded from the survival analysis. Exploratory secondary and 
tertiary objectives and adjusted multivariable analyses on the primary objective will also be 
conducted.   
 
 
Preliminary Data: 
 
We prospectively enrolled 86 patients in our study and performed IV assessment after IV 
placement and within 24 hours, 48 hours, and 72 hours from time of IV placement to assess for 
functionality. The graph below highlights percent of the catheter in the vein as it relates to IV 
failure. 
 
 
 
The table below highlights key study findings of statistical significance. 
 
Percent catheter in vein  
versus longevity 
IV 
Functional 
N=57 
IV Failed 
N=29 
p-value 
 
Percent catheter in vein 
Survival 
Failure 
 
<30% 
30-64% 
≥65% 
0/6 (0%) 
48/71(67.6%) 
 9/9 (100%) 
6/6 (100%) 
23/71(32.3%) 
0/9 (0%) 
<0.0002 
[VALUE] (6/6) 
[VALUE] (4/6) 
[VALUE] (3/6) 
[VALUE] (2/6) 
[VALUE] (3/15) 
[VALUE] (5/18) 
[VALUE] (2/10) 
[VALUE] (4/10) 
[VALUE] (0/9) 
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
<30
30-34
35-39
40-44
45-49
50-54
55-59
60-64
>=65
Failure Rate  
Percent Catheter in Vessel 
Percent Catheter in Vein versus Failure 

 
In our pilot study, 100% of catheters failed in which less than 30% of the catheter was placed 
within the vein and no catheters failed in those IVs in which at least 65% or 3.1 cm of the 
catheter was in the vein.  It is therefore our goal to place at least 3.1 cm of the catheter in the 
vessel lumen. To accomplish this task, a calculation can be performed to determine the minimum 
total catheter length that should be utilized to cannulate a vein at a specific depth.  The figure 
below illustrates this calculation, which is based on the Pythagorean theorem. Given that the 
depth of the vein is a known variable, it is possible to determine the appropriate total catheter 
length required prior to starting the procedure to ensure that at least 3.1 cm of the catheter can be 
placed inside the vein. Based on this hypothetical model, it is possible to achieve the target 
catheter in vein length for depths less than or equal to 1.20 cm using the 4.78 cm option. Any 
depth greater than 1.20 cm would require a longer catheter. A key assumption is that inserters 
approach the target vein with a 45 degrees angle of insertion. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Population and Eligibility: 
 
Subjects will consist of a convenience sample of emergency department patients that require US-
guided IV access. Eligible patients must be greater than 18 years old, and be self-identified as a 
difficult stick. The patient must also recount a prior emergency room visit or hospitalization in 
which more than 2 attempts were required to obtain access, have a history of a rescue catheter as 
the result of an inability to obtain a peripheral IV, or have one of the following conditions: end-
stage renal disease on hemodialysis, IV drug abuse, or sickle cell disease.  
 
Patients are excluded if they do not meet inclusion criteria, have participated in the study prior, 
have already undergone an attempt at vascular access or if the enrollment process has the 
potential to delay their care. Study participation is voluntary and written informed consent will 
be obtained. See Appendix A for Eligibility Checklist. 
 
Numerous emergency room staff members are proficient in placing ultrasound-guided IVs. This 
includes physicians, nurses, and technicians. Staff will be enlisted on a voluntary basis to 
perform insertions on a voluntary basis. 
skin 
45 degree needle 
stick angle 
65% of catheter inside the 
c2 (Needle distance to vein = 
35% of the total catheter 
length) 
a2 
(Vein Depth) 
 
probe 
b2 
vessel 

 
 
Study Procedure: 
 
Initial Assessment  
 
Post-consent, eligible patients will be randomly allocated to the experimental group (forearm) or 
the control group (upper arm) in a ratio of 1:1 via a computer-generated randomization schedule. 
Research staff at the Department of Biostatistics will perform concealed immediate assignment 
by following a block scheme. Sealed envelopes containing the randomized IV access arm will be 
revealed at the bedside.  
 
After patient enrollment, the insertion nurse or physician is engaged to perform the procedure. 
Only providers that are credentialed in ultrasound-guided vascular access will place catheters in 
study subjects. Vessel depth and diameter are measured by research staff and images are saved 
and archived for review by the Emergency Ultrasound Director. Vessel depth is measured on the 
ultrasound unit from the point of contact to the middle of the vein. All catheters are 20 gauge in 
diameter. The research staff will direct the inserter to choose the basilic, cephalic or brachial vein 
at least 2 cm above the antecubital fossa. If the patient is randomized to the control group, the 
inserter will place the Standard Long 4.78 cm catheter. If the patient is randomized to the 
experimental group, the inserter will place the Ultra Long 6.35 cm IV.  
 
Staff members are expected to attempt a minimum of 3 attempts before enlisting another 
provider for help. A functional IV is confirmed by extraction of 5 mL of nonpulsatile blood and 
low-resistance infusion of a 5 mL normal saline flush without evidence of extravasation. Other 
data variables collected include: inserter details, need for rescue inserter, patient pertinent 
medical history, vitals, age, sex, first-stick success, cannulation success or failure, vein diameter, 
catheter in vein longitudinal measurement, angle of insertion, number of venous access attempts, 
time of IV insertion, time to IV insertion, location of IV insertion, distance of IV insertion from 
the antecubital fossa, medications infused, ionic contrast injection for computed tomography. A 
venous access attempt is defined as each time the needle punctures the skin. Once the IV is 
secured, research staff will measure distance from the puncture or catheter insertion site to the 
antecubital fossa to quantify the site to antecubital measurement. See Appendix B for Data 
Collection Tool for insertion-related variables. 
 
Follow-up Assessment  
 
After initial assessment, the catheter will be assessed by the research team every 24 hours as long 
as the patient is hospitalized. At each follow up interval the researcher notes the date/time of 
evaluation and assesses for any signs and symptoms of complications and functionality of the 
device. A catheter is functional if the IV flushes without resistance. Catheters will be assessed 
daily for signs and symptoms of complications. See Appendix C for details regarding the 
assessment for functionality and complications. Any signs or symptoms of complications or lack 
of functionality will be reported to the patient’s primary care team so that management of the IV 
catheter can be addressed. 
 

If the catheter was identified to have any signs or symptoms of complications during follow-up 
assessment the date and time of observation of the complication will be documented in the data 
collection tool and the primary team will be notified of the complication. If the catheter was 
removed prior to the follow-up assessment then the IV removal time and the reason for removal 
will be obtained through chart review. For all catheters removed due to a complication, re-
insertion attempt data will be tracked through the medical record in the nursing section for 
venous lines and need for reinsertion of the IV or escalation to a midline, PICC, or CVC will be 
noted. If the patient is discharged prior to the time of follow-up assessment then the time of 
discharge will be documented and the IV will be presumed functional until time of discharge 
unless otherwise noted in the chart. 
 
The medication administration record will be queried for all medications given through each 
catheter. Vesicants/irritants that are generally given via central line or considered caustic to the 
vessel will be noted in both groups. Number of doses will be recorded. See Appendix D for full 
list of non-neoplastic vesicants/irritants.  
 
Additional data gathered by research staff on follow-up evaluation includes: dwell time in 
days/hours, hospital length of stay, and number of peripheral IVs or rescue catheters for duration 
of stay.  
 
Appendix E represents the data collection documentation tool for all medications.  
 
SVT and DVT rates will be calculated based on upper extremity proven diagnosis of SVT and/or 
DVT in symptomatic cases. Researchers will review all study subject records in EPIC and screen 
for all upper extremity venous Doppler examinations. Radiology interpretations will be reviewed 
for findings of consistent with thrombus. This review will occur thirty days post patient 
discharge. 
 
Infection rate will be tracked using confirmed blood stream infection data from epidemiology. 
These are cases in which line sepsis or bacteremia is confirmed by positive blood cultures. 
 
Cost difference between approaches will be tracked. Equipment costs and personnel costs will be 
tracked. Number and type of IV catheters inserted/attempted will be extracted from the medical 
record. Supply costs will be estimated based on number of IVs attempted. Median time to 
successful catheter placement will serve as a baseline for estimating time needed for future 
reinsertions. Time will be assigned a monetary value. We will also track the number of patients 
from each group that require a PICC or CVC as a rescue catheter.  
 
 
Sample Size and Power Analysis:  
 
For this randomly allocated two-groups experiment, the primary outcome is catheter survival. 
Sample size calculation is based on primary outcome: composite or all cause premature removal 
due to complication of the IV catheter. Based on literatures and a new published article 
immediately prior to  study period, we estimate sample size using the median survival time 30 
hours for the 4.78 cm standard IV option. 91 subjects per group for a total sample size of 182 
subjects is the minimum recommendation assuming a 10% dropout rate. This calculation 

achieves power of 80% to detect a hazard ratio of 0.63 or less for line failure of the 6.35 cm ultra 
long IV based on log-rank test.  
 
 
 
Statistical Analysis: 
 
Characteristics of enrolled and eligible patients will be summarized between two arms using 
means [standard deviations] and medians [interquartile ranges] compared by t-tests or Wilcoxon 
tests for continuous variables and frequencies (percentages) compared by chi-squared tests or 
Fisher’s exact tests for categorical variables.  
 
Survival analysis methods (Kaplan-Meier curves, the log-rank test for continuous failure times or 
logistic model for discrete failure times) will be used for analyzing times to IV failure with non-
failure times treated as censored. Proportions of SVT, DVT and catheter infection rates will be 
reported separately for each arm. Nonparametric summaries and a Wilcoxon Rank sum test will 
be used for the cost data. To test the effect of catheter variables on survival, we will further use 
Cox proportional hazard regression models for time-to-event outcomes and logistic regression 
models for binary outcomes. P-values of less than 0.05 will be considered statistically 
significant. Analysis will be conducted using SAS 9.4. 
 
 
Study Site: 
 
William Beaumont Hospital, Royal Oak (RO) campus is the proposed site for the investigation. 
It is a 1,100 bed major academic and referral center with Level 1 adult trauma and Level 2 
pediatric trauma status. A major teaching facility, Beaumont, Royal Oak has 55 residency and 
fellowship programs with 454 residents and fellows. Beaumont is the exclusive clinical partner 
for the Oakland University William Beaumont School of Medicine. The Beaumont Research 
Institute was established more than 30 year ago at Royal Oak and offers research support 
services to clinical investigators. 
 
The Royal Oak (RO) Emergency Center (EC) has the resources available to complete this 
project. This site is a tertiary care, level I trauma center with an annual ED census greater than 
130,000 visits. I collaborated with nursing leadership in 2015 and implemented an ancillary 
staff-training program for placing US-guided IVs. Nearly forty ancillary staff members are 
certified in this procedure. Further, weekly logs of IVs placed under US-guidance show that an 
average of 10 US-guided IVs are placed daily. The RO EC has 130,000 annual visits of which 
many patients have difficult access. We also have 11 portable US machines with high frequency 
linear transducers that are ideal for vascular imaging.  
 
Beaumont Health is Michigan’s largest health care system and is the most preferred for health 
care in the tri-county area, according to National Research Corporation survey data. A not-for-
profit organization, it was formed in 2014 by Beaumont Health System, Botsford Hospital and 
Oakwood Healthcare to provide patients with the benefit of greater access to extraordinary, 
compassionate care, no matter where they live in Southeast Michigan. Beaumont Health has total 
net revenue of $4.5 billion and consists of eight hospitals with 3,429 beds, 187 outpatient sites, 

nearly 5,000 physicians, 38,000 employees and 3,500 volunteers. In 2017, Beaumont Health had 
175,700 inpatient discharges, 17,800 births and 575,000 emergency visits. 
 
 
 
Potential Impact: 
 
Optimization of peripheral vascular care is a critical strategy to improve patient outcomes and 
reduce health care costs. Enhanced dwell times will lead to improved patient/staff satisfaction, 
decreased interruptions in care with shorter hospital length of stay, and decrease in complications 
such as thrombosis, bleeding, and infection. Over 2 billion IV catheters are used worldwide 
annually with less than one-third of catheters actually ending up in a patient. No other industry 
would accept this degree of failure in its most essential and necessary process to deliver care. In 
a study by Rickard et al in 2012, a patient required an average of 1.7 IV catheters per 
admission.15 With a cost of approximately $35 per catheter for straightforward insertions, even a 
slight improvement in dwell time has the potential to save our health system millions of dollars.  
 
 
 
 
 
 

References 
 
1. 
Costantino TG, Parikh AK, Satz WA, et al. Ultrasonography-guided peripheral 
intravenous access versus traditional approaches in patients with difficult intravenous 
access. Ann Emerg Med. 2005;46(5):456-461. 
2. 
Keyes LE, Frazee BW, Snoey ER, et al. Ultrasound-guided brachial and basilic vein 
cannulation in emergency department patients with difficult intravenous access. Ann 
Emerg Med. 1999;34(6):711-714. 
3. 
McCarthy ML, Shokoohi H, Boniface KS, et al. Ultrasonography Versus Landmark for 
Peripheral Intravenous Cannulation: A Randomized Controlled Trial. Ann Emerg Med. 
2016;68(1):10-18. 
4. 
Bregenzer T, Conen D, Sakmann P, et al. Is routine replacement of peripheral 
intravenous catheters necessary? Arch Intern Med. 1998;158(2):151-156. 
5. 
Catney MR, Hillis S, Wakefield B, et al. Relationship between peripheral intravenous 
catheter Dwell time and the development of phlebitis and infiltration. J Infus Nurs. 
2001;24(5):332-341. 
6. 
Dargin JM, Rebholz CM, Lowenstein RA, et al. Ultrasonography-guided peripheral 
intravenous catheter survival in ED patients with difficult access. Am J Emerg Med. 
2010;28(1):1-7. 
7. 
Elia F, Ferrari G, Molino P, et al. Standard-length catheters vs long catheters in 
ultrasound-guided peripheral vein cannulation. Am J Emerg Med. 2012;30(5):712-716. 
8. 
Soifer NE, Borzak S, Edlin BR, et al. Prevention of peripheral venous catheter 
complications with an intravenous therapy team: a randomized controlled trial. Arch 
Intern Med. 1998;158(5):473-477. 
9. 
Dychter SS, Gold DA, Carson D, et al. Intravenous therapy: a review of complications 
and economic considerations of peripheral access. J Infus Nurs. 2012;35(2):84-91. 
10. 
Fields JM, Dean AJ, Todman RW, et al. The effect of vessel depth, diameter, and 
location on ultrasound-guided peripheral intravenous catheter longevity. Am J Emerg 
Med. 2012;30(7):1134-1140. 
11. 
Stone P, Meyer B, Aucoin J, et al. Ultrasound-guided peripheral IV access: Guidelines 
for practice. American Nurse Today. 2013;8(8). 
12. 
Gorski L, Hadaway L, Hagle ME, et al. Infusion Therapy Standards of Practice. Vol 39 
(1S). Norwood, MA: Infusion Nurses Society; 2016. 
13. 
Gorski L, Hadaway L, Hagle M, et al., eds. Policies and Procedures for Infusion 
Therapy. 5th ed. Norwood, MA: Infusion Nurses Society; 2016. 
14. 
O'Grady NP, Alexander M, Burns LA, et al. Summary of recommendations: Guidelines 
for the Prevention of Intravascular Catheter-related Infections. Clin Infect Dis. 
2011;52(9):1087-1099. 
15. 
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. 
 
 

Appendix A: Eligibility Checklist 
MRN:   
 
Enrollment Date:      /      /201       
Enrollment Time:       : 
       
 
Inclusions: All must be “yes” or do not enroll participant 
Yes 
No 
Patient self-reports a history of difficult IV access 
Patient has a history of AT LEAST ONE of the following: 
(indicate which patient meets) 
Pt. recounts a prior emergency room visit/hospitalization when > 2 
sticks required to obtain access 
History of a rescue catheter (such as US-guided IV, PICC line, midline, 
or CVC) ESRD on dialysis 
History of IV Drug 
Use History of 
Sickle Cell 
Patient is 18 years of age or older 
 
Exclusions: All must be “no” or do not enroll participant 
Yes 
No 
Patient is under the age of 18 years of age 
Patient refuses to participate in the study 
Previous Inclusion in the study 
Cognitively impaired 
 
 
Form Completed by:   
 
 
(Printed name)  
 
 
   (Signature) 
 
Date:  
Time:   
  
 
 
 
Principal Investigator:  
(Printed name)  
 
 
(Signature) 
 
Date:  
 Time:   
 
 
 
 

Appendix B: Insertion-Related Data  
 
Research Staff completing form (signature/date):    
 
 
 
 
 
 
 
Catheter Type (circle): 
Ultra Long IV 
Standard IV 
 
Depth (cm) Diameter (cm) # Attempts Depth (cm) Diameter (cm) # Attempts 
1st Venous Access point 
2nd Venous Access point 
Inserter #1 ID: 
1st Venous Access point 
2nd Venous Access point 
Inserter #2 ID: 
 
Minutes for procedure completion (time from needle to skin to dressing site):   
 
 
Time at Completion of Insertion:   
 
 
Initial EC Vitals: BP  
HR  
 
 
 
Gender: 
 
Age:  
 
 
 
BMI:  
 
 
 
Location of Successful Cannulation  
(Mark 1/2/3 for access attempts, circle successful site):  
Left  
 
Right 
 
Insertion site distance from AC fossa (cm):   
 
 
Disposition (Circle):  Observation 
Regular 
Progressive 
ICU 
Discharge 

Appendix C: Functionality and Complications 
 
Day 
Functional 
1: draw 
2: flush 
3: infusing 
4: failed 
Removal 
Time 
Reason 
for 
Remov
al 
Venous 
Doppler 
1: + for dvt  
2: + for svt  
3: + for dvt/svt 
4: - for both  
5: none  
Lab 
confirmed 
infection 
Y/N 
Discharge 
<24 hrs 
from 
insertion  
Replacement 
Access in the 
case of failure 
1: Midline 
2: PICC 
3: PIV 
4: US PIV 
5: CVC 
Research 
staff 
initials 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
28 
29 
30 
Reasons for Removal: (1) Completion of therapy; (2) infiltration; (3) infection; (4) dislodgement; (5) leaking; (6) 
pain; (7) other; (8) unknown                  
 
Post processing data 
Angle of Insertion (°) 
Length in vein (cm) 
% Length in Vein 
Signature/Date:  
 
 
 
 
 
 

Appendix D: List of Vesicants (Red) and Irritants (Yellow) 
 
 
 
 
 
 
 

Appendix E: Medications 
 
Day 
Medications transfused via catheter 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
28 
29 
30