Blood Sampling and Extended Dwell Catheters: A Randomized Trial of Blood Sampling Functionality Based on Site Selection
Phase: NA
Conditions: IV Catheter-Related Infection or Complication, Vascular Access Complication, Peripheral Venous Access
Sponsor: Corewell Health East

TITLE:  
UPPER ARM VS. FOREARM PLACEMENT OF EXTENDED DWELL 
CATHETERS: A COMPARATIVE EVALUATION OF BLOOD SAMPLING AND 
FUNCTIONALITY 
 
NCT04409418 
 
Approval date: 07/12/2022 
 
Study Protocol and Statistical Analysis Plan 

Version 06/16/2022         PI: Amit Bahl, MD
UPPER ARM VS. FOREARM PLACEMENT OF EXTENDED DWELL CATHETERS: A 
COMPARATIVE EVALUATION OF BLOOD SAMPLING AND FUNCTIONALITY
1
Background:
Nearly all hospitalized patients require intravenous (IV) access for treatment. 
Patients rely on functional vascular access to receive life saving IV therapies. 
Generally, peripheral IVs have high failure rates with 19-25% of IVs failing prior to 
completion of therapy and 45-56% of ultrasound-guided peripheral IVs failing prior 
to completion of therapy. Dislodgment, infiltration/extravasation, and phlebitis are 
common complications that lead to early failure. 1-5 
Many patients require ongoing blood draws or phlebotomy for laboratory testing 
during hospitalization. Hospitals generally avoid phlebotomy from peripheral IV 
catheters because they have been associated with increased rates of inaccurate 
laboratory testing and can increase dislodgment, infiltration, and phlebitis 
complications.6 Patients are subjected to multiple needlesticks for blood sampling 
causing patient dissatisfaction and anxiety.7 Further, health care workers are 
exposed to blood borne pathogens as blood draws can cause needlestick injuries.8   
Extended dwell catheters (EDC) offer a viable alternative to peripheral IVs, 
especially for patients with prolonged hospital stays. EDCs are peripheral venous 
access devices placed under ultrasound guidance that are most commonly placed in 
the basilica, brachial, or cephalic veins and can be inserted above or below the 
antecubital fossa. These catheters can be left in place for up to 30 days and have an 
improved survival profile when compared to peripheral IVs.9.10 While there is 
limited evidence on blood draw ability from these catheters, EDCs can be accessed 
for routine blood draws and potentially eliminate the need for additional 
needlesticks. 
There is very limited research evaluating the impact of IV placement site on 
functionality or blood sampling ability. Only one small study of ultrasound-guided IV 
placements evaluated site in a prospective comparative fashion. The comparison 
was limited to evaluation of 56 patients in the “distal” or forearm group which 
comprised insertions in the antecubital/forearm area and 95 patients in the upper 
arm site. The authors concluded that “distal” placements have improved survival.11 
Further research is necessary to draw conclusions about EDCs and 
functionality/blood draws.
The potential value of forearm placements is especially relevant for patients with 
renal insufficiency. In the past three decades, there has been a significant increase in 
the patient population with chronic kidney disease. As the renal disease may 
progress and patients may require dialysis and establishment of an arteriovenous 
fistula, it is necessary to preserve the vasculature of the upper arm.12 
IRB NUMBER: 2020-053
IRB APPROVAL DATE: 07/12/2022

Version 06/16/2022         PI: Amit Bahl, MD
UPPER ARM VS. FOREARM PLACEMENT OF EXTENDED DWELL CATHETERS: A 
COMPARATIVE EVALUATION OF BLOOD SAMPLING AND FUNCTIONALITY
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In summary, there is a gap of knowledge on EDCs and blood draw ability regardless 
of site of insertion. While survival of EDCs has been evaluated, there is no literature 
that compares survival of upper arm to lower arm placement.
Hypothesis/Objectives:
We hypothesize the forearm is the favorable site for ultrasound-guided IV 
establishment in terms of survival. Placement of the catheter in the forearm to avoid 
antecubital fossa or muscle bellies of the upper arm reduces kinking and involves 
insertion in more shallow vessels and likely enhances survival of the catheter.
We hypothesize the forearm provides similar blood sampling functionality 
compared to upper arm insertion. 
We aim to quantify the difference in blood draw ability and catheter survival, 
comparing placement of an extended dwell catheter in the upper arm to the 
forearm. 
Specific Aims:
Specific Aim 1: To compare upper arm versus forearm extended dwell catheter 
placement for blood sampling functionality.
For Aim 1, blood sampling ability of the forearm compared to upper arm will be 
evaluated by daily blood draws prior to patient discharge. The event is failure to 
aspirate blood during follow-up assessment during hospitalization.
Specific Aim 2: To compare upper arm versus forearm extended dwell catheter 
placement for dwell time/survival of catheter. 
For Aim 2, an improved survival of the forearm placed catheter will be evaluated by 
functionality of catheter for intravenous therapy prior to patient discharge. The 
event is failure of functionality identified as inability to infuse without resistance 
during follow-up assessment during hospitalization. Duration of dwell and 
functional failure of the catheter will be employed to estimate catheter survival.  
Specific Aim 3: To compare upper arm versus forearm extended dwell catheter 
placement for symptomatic catheter-related upper extremity venous thrombosis 
(CR-UEVT).
For Aim 3, we will measure incidence of all symptomatic CR-UEVT inclusive of  
superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed 
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Version 06/16/2022         PI: Amit Bahl, MD
UPPER ARM VS. FOREARM PLACEMENT OF EXTENDED DWELL CATHETERS: A 
COMPARATIVE EVALUATION OF BLOOD SAMPLING AND FUNCTIONALITY
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by upper extremity venous duplex evaluation, to assess for a difference in 
thrombosis when an EDC is placed in the forearm compared to the upper arm. 
Study Design 
We propose a single-site, prospective two-arm randomized investigation of blood 
sampling and catheter survival of extended dwell catheters when site selection is 
evaluated. Specifically, EDC insertions in the forearm will be compared to upper arm 
insertions. The primary objective of this study is to demonstrate that blood 
sampling of the forearm (experimental group) is not inferior to blood sampling of 
the upper arm (control group). Exploratory secondary and adjusted multivariable 
analyses will also be conducted.
A single lumen, 20 gauge 8 cm EDC (BARD Powerglide STTM Midline Catheter) will 
be utilized for this evaluation.  
We aim to recruit 96 patients with 48 in each arm to assess blood sampling 
functionality. 
Study Population and Eligibility:
A cohort of clinicians are proficient in ultrasound-guided vascular access at our 
hospital. In the emergency department (ED), several physicians and nurses are 
competent in the procedure. On the inpatient side, the Vascular Access Team (VAT) 
at our hospital receives daily consults for patients that have advanced vascular 
access needs. This includes patients with prolonged vascular access needs and/or 
difficult vascular access patients. All inserters are trained to place a number of 
catheters with ultrasound-guidance: peripheral IVs, midlines, and EDCs.  
Eligible inpatient participants include: 1. Consult to VAT for vascular access device 
placement 2. Patient requires peripheral access. 3.18 years and older. Eligible ED 
patients include 1. 18 years and older 2. Difficult vascular access and anticipated 
hospital admission. Difficult vascular access is defined as: 1. Patient with no visible 
veins (>2 mm) or palpable veins in the upper extremity. Patients will be excluded if: 
1. Multiple lumens required 2. Existing functional vascular access device proximal to 
the targeted area of insertion. This does not include superficial non-ultrasound 
guided peripheral IVs. 3. Upper extremity cannot be accessed due to a coexisting 
medical condition. 4. Cognitively impaired.
Patients meeting inclusion criteria will be consented and randomized by research 
staff to either upper arm or forearm insertion. If the inserter has no adequate target 
visualized in the randomly selected site, the inserter may evaluate another site that 
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IRB APPROVAL DATE: 07/12/2022

Version 06/16/2022         PI: Amit Bahl, MD
UPPER ARM VS. FOREARM PLACEMENT OF EXTENDED DWELL CATHETERS: A 
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is more suitable for cannulation. The site of insertion will be recorded and pertinent 
information will be collected similar to other enrollments.
Practitioner Participation/Training
Advanced Practice Providers (APP) within the VAT and ED practitioners proficient 
in ultrasound-guided vascular access at the Royal Oak campus are eligible to place 
catheters for this study. Participation in this study is not required and will be 
carried out on a strictly voluntary basis. Providers have limited experience with the 
BARD Powerglide STTM Midline. The clinical team from BARD will be expected to 
develop an educational/training pathway for providers to achieve proficiency prior 
to subject recruitment. A possible training/credentialing pathway may consist of: 1 
hour didactic training followed by phantom training on a vein block +/- insertions 
on real patients. Once trained, providers can train the other providers. 
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 inserter is engaged to perform the procedure. Only 
providers that are credentialed in ultrasound-guided vascular access will place 
catheters in study subjects. The research team will capture and save images of 
vessel depth and vessel diameter in short axis using the Sonosite or Mindray 
ultrasound equipment. Ultrasound guidance will be used for the initial assessment 
and procedure. The high frequency linear array transducer will be used for all 
procedures. Inserters will evaluate the vessel for valves, thrombosis, trajectory, and 
collapsibility per routine care. If the vein is appropriate for cannulation, the 
practitioner will continue with the procedure. Post-cannulation and post 
securement, functionality is confirmed with blood sampling (10 cc) and flush 
without resistance. A neutral pressure needle-free IV connector (One-link by Baxter 
Medical) will be connected to all lines. If the patient is randomized to the control 
group, the research staff will direct the inserter to choose either the basilic, cephalic 
or brachial vein at least 2 cm above the antecubital fossa. If the patient is 
randomized to the experimental group, the research staff will direct the inserter to 
place the catheter into the forearm at least 10 cm away from the antecubital fossa to 
ensure the distal tip of the catheter does not terminate in the antecubital fossa. The 
cephalic and basilic veins are typically cannulated in the forearm. If no adequate 
target is visualized in the randomly selected site, the inserter may evaluate another 
IRB NUMBER: 2020-053
IRB APPROVAL DATE: 07/12/2022

Version 06/16/2022         PI: Amit Bahl, MD
UPPER ARM VS. FOREARM PLACEMENT OF EXTENDED DWELL CATHETERS: A 
COMPARATIVE EVALUATION OF BLOOD SAMPLING AND FUNCTIONALITY
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site that is more suitable for cannulation. The site of insertion will be recorded and 
pertinent information will be collected similar to other enrollments.
The research team also will document practitioner details, the time of EDC 
placement, number of attempts, need for a rescue inserter, the vein that was 
cannulated, catheter to vein ratio, and the indication for EDC placement. Data will be 
collected from the electronic medical record and includes: age, gender, BMI, vital 
signs, relevant past medical history for difficult vascular access, and number, type, 
and site of previous vascular access devices during the current admission. The 
medication administration record will be queried for all medications given through 
each catheter. Specific attention will be given to vesicants listed in Appendix A. All 
upper extremity venous doppler imaging reports will be reviewed for thrombosis. 
Follow-up Assessment 
Investigators will perform a follow-up on the catheters daily while hospitalized. If 
qualified staff is not available, chart review will be performed on the first day staff 
returns back to the hospital. At each follow-up interval, the researcher notes the 
time of evaluation and assesses for blood sampling and functionality. At our 
institution, midlines and central lines can only be accessed for blood draws with a 
physician order. These instances are tracked in the medical record and will be 
recorded. The hospital policy for blood sampling follows Lippincott procedures for 
central venous access catheter blood sampling available at procedures.lww.com. If 
the qualified staff is able to aspirate blood from the catheter, blood sampling is 
considered intact. This sampling should be followed immediately by a 5-10 cc flush 
of saline to ensure no blood is visible in the tubing system. If blood does not readily 
aspirate, the line is flushed with 10 cc of saline and blood draw is re-attempted. If 
the catheter is unable to aspirate blood, the date and time of the failure of blood 
sampling is recorded. The presence or absence of blood within the lumen proximal 
to the hub is noted for occlusion for all VADs that cannot aspirate blood. After 
accessing the catheter, researchers are expected to flush and clean the catheter hub 
per institutional protocol for care and maintenance. All practitioners are given 
written instructions on this protocol. General functionality is also recorded if the 
VAD flushes with 5 ml of normal saline without resistance after the blood draw 
attempt. If the catheter cannot be flushed, the date and time of failure are recorded. 
If the catheter is identified to have failed prior to the follow-up assessment the date 
and time of failure and the reason for failure is obtained from chart review. If the 
patient is discharged prior to the time of follow-up assessment then the time of 
discharge is documented and the IV is presumed functional until time of discharge 
unless otherwise noted in the chart.
IRB NUMBER: 2020-053
IRB APPROVAL DATE: 07/12/2022

Version 06/16/2022         PI: Amit Bahl, MD
UPPER ARM VS. FOREARM PLACEMENT OF EXTENDED DWELL CATHETERS: A 
COMPARATIVE EVALUATION OF BLOOD SAMPLING AND FUNCTIONALITY
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Sample Size and Statistical Analysis
The sample size for the proposed work is based on the first aim since the other aims 
will use the same samples.  We determined the sample size for the proposed study 
based on the assumption that upper extremity catheters have successful blood 
sampling 50% of the time and clinically acceptable practice of 75% success applies 
to the experimental arm. If there is a true difference in favor of the experimental 
group of 25%, then 48 patients are required to be 95% sure that the upper limit of a 
one-sided 95% confidence interval (or equivalently a 90% two-sided confidence 
interval) will exclude a difference in favor of the control or upper arm group of more 
than 20%. Considering dropout rate and early discharge, we doubled the sample 
size to 96 patients. When evaluating volumes of midline catheters placed at our 
institution, this is a feasible number of patients to recruit over 4-6 months.    
Initial analyses will include descriptive statistics for all outcomes using means, 
standard deviations, and ranges for continuous measures, and frequencies and 
percentages for categorical measures.  We will compare demographic and other 
potential confounding variables between arms using either Pearson’s chi-square 
test (dichotomous variables such as gender) or a two-sample t-test (continuous 
variables such as age), as appropriate. Aims will be assessed using survival analysis 
with Kaplan-Meier curves, Pearson’s chi-squared test, and logistic regression. 
 
Site 
William Beaumont Hospital, Royal Oak (RO) campus 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.
Principal Investigator
I have specialized training in emergency ultrasound and completed fellowship in the 
field in 2008. Since that time, I have served as Director of Emergency Ultrasound for 
Emergency Medicine. Further, since 2016 I have functioned as the Medical Director 
for inpatient VAT.  Additionally, I have a specific interest in ultrasound-guided 
vascular access with several peer-reviewed publications and national presentations 
in this area. Specifically, I have conducted and published prospective randomized 
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controlled trials investigating survival of intravenous devices. My CV is included for 
further details.
References:
1.
Bregenzer T, Conen D, Sakmann P, et al. Is routine replacement of peripheral 
intravenous catheters necessary? Arch Intern Med. 1998;158(2):151-156.
2.
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.
3.
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.
4.
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.
5.
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.
6. 
Wollowitz A, Bijur PE, Esses D, Gallagher E. Use of butterfly needles to draw blood is 
independently associated with marked reduction in hemolysis compared to intravenous 
catheter. Academic Emergency Medicine. 2013;20:1151-55.
7. 
Horowitz SH. Venipuncture-induced neuropathic pain: the clinical syndrome with 
comparisons to experimental nerve injury models. Pain. 2001;94:225-229.
8.
Occupational Safety & Health Administration. (n.d.) Needlestick/sharps injuries. 
Retrievedfrom https://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html
. Accessed December 2018.
9.
Bahl A, Hang B, Brackney A, Joseph S, Karabon P, Shotkin P. Standard long IV catheters 
versus extended dwell catheters: A randomized comparison of ultrasound-guided 
catheter survival. American Journal of Emergency Medicine. 2018. Epub ahead of print.
10. 
Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J 
Emerg Med. 2016;51(3):252-8
11.
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.
12. 
Saad TF. Vein Preservation and Alternative Venous Access. Endovascular Today. 2008
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Appendix A
IRB NUMBER: 2020-053
IRB APPROVAL DATE: 07/12/2022