Ultrasound-guided Peripheral IV vs. Standard Technique in Difficult Vascular Access Patients by ICU Nurses
Phase: NA
Conditions: Difficult IV Access
Sponsor: Queen's University

 
 
 
 
 
Research Proposal Cover Page 
 
 
 
Title of research 
project 
Ultrasound-guided peripheral IV vs. standard technique in 
difficult vascular access patients by ICU nurses.  
Research team 
Name 
Position 
Telephone  
E-mail 
Principle 
investigator 1 
Dr. Mohammed 
Alshamsi 
ICU fellow 
3433333986 
17mras@queen
su.ca 
Supervisor 
Dr. Gordon 
Boyd 
ICU attending 
6135392754 
boydj@kgh.kari.
net 
Health 
institution 
involved 
 
Kingston Health Sciences Centre 
Expected 
duration 
 
6 months starting from December, 2018 till May ,2019. 
Expected 
budget 
The study will utilize resources condensed within the standard 
of care. 
Declaration: I agree to submit this final proposal draft for approval and I will 
have full responsibility to manage the project and to follow up various 
activities in order to finish it in time. I will ensure that the research will not 
deviate from the protocol described. If significant protocol amendments are 
required as the research progresses, I shall submit these to the Research 
Review Committee for approval. Also I will be responsible to provide progress 
reports and final report for my program research subcommittee for revision 
before final dissemination 
 
l-P.I 1:          Mohammed Al-Shamsi                        Date:         01  /    11       /    2018  
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
Ultrasound-guided peripheral IV  vs. standard technique in 
difficult vascular access patients by ICU nurses.  
 
‘’Research Protocol’’ 
 
 
 
1-Introduction:  
 
Peripheral intravenous access is one of the most common and most important 
invasive procedure performed by ICU nurses. The importance of being able to 
insert an IV quickly, successfully and with little discomfort cannot be 
overestimated.  Establishing good peripheral access is essential in ICU because 
this allows timely administration of fluid and medication and also allow early 
discontinuation or even avoidance of central line when there are no specific 
indications for their use. 
 
      Failure in establishing good peripheral access is a very frequent problem in 
ICU because of the high prevalence of chronic illness, peripheral edema, obesity 
and for many other reasons. Multiple attempts in establishing IV access in 
difficult IV access (DIVA) patients frequently lead to a high level of patient 
discomfort and nurse’s frustration. Peripheral IV cannulation can be incredibly 
time intensive for nurses when patients are DIVA.  Furthermore, failure of 
peripheral intravenous cannulation (PIVC) in ICU setting frequently leads to 
insertion of a central line or PICC which are associated with more risk of 
catheter-associated infection and other serious complications [1]. 

 
 
 
 
 
      Using Ultrasound to guide central line insertion is the standard of care but 
ultrasound-guided PIVC in difficult patients remained poorly utilized rescue tool 
despite its potential advantages in the ICU setting. Ultrasonographic guidance 
may improve the rate of successful PIVC in patients who have been historically 
difficult to access, leading to less time spent obtaining intravenous access and 
greater patient satisfaction. 
 
     In difficult IV access patients, we hypothesize that ultrasound-guided 
peripheral intravenous cannulation (USG-PIVC) increases the success rate of 
peripheral IV access in difficult IV access ICU patients. In addition, we 
hypothesize the USG-PIVC is a very safe procedure and is associated with very 
few minor complications. 
 
 
    
 
2- Literature  review: 
 
      Ultrasound-guided central venous access has been well studied throughout 
the past few decades, several studies showed an increased success rate and 
decreased complications compared to the traditional landmark approach [2]. 
 
        Ultrasound-guided peripheral intravenous cannulation (USG-PIVC) is a 
technique that can be utilized in patients with difficult peripheral IV cannulation 
which is a frequent problem encountered in ICU. There are multiple factors 
associated with failure in establishing peripheral IV access in adults, e.g., obesity, 
IVDU, DM, nurse’s experience and poor peripheral venous visibility and 
palpability [2,3]. James CR et al. found that clinical gestalt is an excellent 
predictor in determining the probability of PIVC first-time insertion success or 
failure. He suggested that clinical gestalt can prospectively stratify patients into 
groups according to their risk of PIVC placement failure [3]. 

 
 
 
 
 
          There are multiple small studies in the emergency literature which found 
that UG-PIVC by ED physician and nurses in DIVA patients can lead to better 
success rate, few punctures and greater patient satisfaction compared with 
traditional landmark technique. In a prospective observational study by Brannam 
et al., he demonstrated that emergency nurses could be trained to use US-
guided PIV access with high success rates and few complications [5].  In another 
small prospective randomized trial in ED, the superiority of ultrasound-guided 
peripheral intravenous cannulation was not supported. The investigators found 
that ultrasound-guided peripheral intravenous cannulation did not decrease the 
number of attempts or the time to successful catheterization, nor did it improve 
patient satisfaction compared with the group that did not use ultrasonography 
[6].         
 
       In another small randomized prospective study conducted in an emergency 
department in 2005, Costantino et al found that ultrasound-guided IV 
cannulation performed by emergency physicians are more successful than 
traditional ‘‘blind’’ techniques, requires less time, decreases the number of 
percutaneous punctures, and improves patient satisfaction in patients with 
difficult I.V access [7]. In a recent single-center randomized prospective study in 
ED, nurses were found to be more successful in obtaining IV access using US 
guidance than palpation technique in difficult access patients. Nurses using US-
guided technique had a higher success rate of 76% in placing a functional IV 
compared to 56% using the standard palpation technique [8].    
 
       In a single-center retrospective study, a single physician attempt in placing 
peripheral IVs using ultrasound in difficult cannulation ICU patients found that 
first attempt success rate was 77% with 99% overall success rate. As a result of 
placing these PIV catheters, 40 central lines were discontinued, and 34 central 
lines were avoided. This study has a limitation because it is a retrospective study 
examining a single physician’s experience with the technique [9]. In another 

 
 
 
 
small ICU RCT, the ultrasound-guidance technique was more successful without 
increasing cannulation time despite the use of additional equipment [10]. 
 
     In a recent systematic review published in 2016, the authors found that  
the ultrasound-guided technique improves the success rate of intravenous 
access significantly (OR = 3.00, p < .0001) and decreased the number of 
attempts in the overall group of difficult intravenous-access patients [11]. 
 
      Ultrasound-guided peripheral IV cannulation has a steep learning curve. 
Stolz La found that new learners of the procedure are capable of a greater than 
70% success rate after placement of four USG PIVCs. A success rate of greater 
than 88% is achieved after 15 to 26 attempts [12] 
 
      There are multiple factors associated with a high failure rate and shorter 
catheter survival when USG-PIVC is used. In the study conducted by Michael D 
et al., he found that veins less than 3 mm in diameter or greater than 1.5 cm in 
depth were associated with high failure rate [13]. In another study conducted by 
J. Matthew et al., he found 2 important factors associated with short catheter 
survival when performed with ultrasound guidance. Deep veins (depth > 1.2 cm) 
and proximal location were associated with early catheter failure when they are 
performed with ultrasound-guided technique [14]. 
 
 
       Based on many previous studies [6,13,15], complication rate associated 
with USG-PIVC is the same as traditional blind techniques. Adhockery et al. 
found that the infection rate of USG-PIVC is the same as a blind technique [14]. 
Thomas G et al. reported no significant complications in their RCT in USG-PIVC 
group  
 
 
 

 
 
 
 
 
3. Methodology 
 
 
3.1. Study design:  
 
          
      This is a randomized controlled single-site trial with two groups in a parallel 
design. In this study, we will compare the success rate of ultrasound-guided 
peripheral intravenous access (experimental group) to a traditional landmark 
approach (control group) in patients with DIVA. It is a non-blinded study 
because of the nature of the intervention. 
 
3.2. Setting : 
 
      This study will be conducted in the adult intensive care unit of Kingston 
general hospital which is an urban university teaching hospital with 33 ICU beds 
and more than 1000  ICU admissions per year.  
 
3.3.Study population:  
 
     
      A convenience sample of ICU patients with difficult cannulation will be 
selected and enrolled in this study. Difficult cannulation is defined as poorly 
visible and palpable upper extremities veins due to any cause after two failed 
attempts using traditional technique. All consecutive patient with difficult 
cannulation will be assessed for enrolment in this study starting from December 
2018 till May 2019. A research assistant will be available for patient enrollment 
and data collection between 8:00 AM till 5:00 PM during weekdays.  
 
3.4. Inclusion / exclusion criteria 
 
Inclusion Criteria: 

 
 
 
 
 
• 
    18 years of age or older 
• 
    DIVA patients after two failed attempts 
 
Exclusion Criteria: 
 
• 
    Upper-extremity cellulitis 
• 
    Unstable and need urgent intravenous access (central line or IO). 
 
 
 
3.5. Study procedure 
 
   
      The study will be conducted in two phases. Phase one will involve 
education and training of a cohort of nurses to perform US-guided PIVC. 
Experienced ICU nurses with two years of experience will be recruited to 
participate in the study. All nurses will have no prior experience in USG-PIVC 
prior to this study. Education consists of didactic two hours lecture and hands-
on practice on synthetic training models (blue phantoms). This will cover basic 
machine operation, image optimization, sonographic anatomy and ultrasound 
techniques for guiding PIVC. This will be followed by 2-3 months observation 
period during which nurses have to perform at least 15 successful ultrasound-
guided PIVC on live subjects before actual patients' enrolment. Phase two 
involved patient enrolment of difficult peripheral access ICU patients meeting 
specific inclusion and exclusion criteria. Patients will be systematically 
randomized to the ultrasound-guided or the landmark technique (control) using 
envelop randomization.  
 
      Only upper limb veins will be selected for cannulation. All the cannulation 
will be done under semi aseptic technique as per standard PIV placement and 
cleaning procedures. USG-PIVC will be performed using sterile gel for the 

 
 
 
 
procedure, and the ultrasound probe will be covered with sterile adhesive films 
(e.g., 3M Tegaderm). Two already available departmental ultrasound machines 
(sonosite edge ) will be used for this study. High-frequency probe (5-10 MHz) 
with single operator out of plane (short access) approach will be used for 
ultrasound-guided cannulation.  
 
      When using USG-PIVC, veins deeper than 1.5 cm from the skin surface and 
veins with diameter less than 0.3 cm will be avoided because of high failure rate 
and increased risk of extravasation.   Catheter length and size will be selected 
based on the depth and size of veins to ensure that a sufficient portion of the 
catheter will remain in the vessel to prevent early failure. 
 
 
3.6: outcome measures:  
  
Primary outcome measure: 
 
 Successful cannulation by ICU nurses. 
 
 
 
Secondary outcome measures:  
 
 Number of punctures attempted. 
 24 hours catheter survival. 
 Complications (cellulitis ,phlebitis arterial puncture,  nerve  injuries,            
infiltration, hematoma formation). 
 Subsequent need for PICC or central line. 
 
 
3.7. Data collection and processing 
 
      

 
 
 
 
      Intensive care nurses participating in the study will record all the data 
related to outcome measures on a preprinted data collection forms in real time. 
The raw data will be entered by investigators into SPSS software for analysis. 
 
3.8. Data analysis 
 
  
      An intention-to-treat analysis will be performed. Using the power of 80% and 
alpha of 0.05, the sample size was calculated to be 25 per group. Categorical 
variables such as success rate, catheter survival rate and complication rate will be 
presented as a percentage and will be compared using Fisher exact tests. 
Continuous variables such as insertion time and the number of attempts will be 
shown as mean, median (with interquartile ranges), and 95% confidence interval (CI) 
and will be compared using Mann-Whitney U tests.  All statistical analysis will be 
conducted using IBM SPSS Base 25 for Windows. 
 
 
4. Definitions:  
 
     
  Difficult IV access patient is defined as failure of 2 attempts to cannulate upper 
limb veins in patients with invisible or non-palpable veins after application of a 
tight proximal tourniquet.  Successful cannulation is defined as the ability to 
aspirate blood and ability to flush the cannula without resistance to the flow 
and without evidence immediate extravasation.  
 
      Failure PIVC is defined as extravasation with initial infusion or inability to 
withdraw blood. Failed cannulation is defined as failed three attempts excluding 
the initial two attempts which are part of the definition of difficult venous 
cannulation.  Time will be recorded in minutes in real time by the ICU nurse with 
time zero defined as the first skin puncture after patient randomization in the 
study.  
 

 
 
 
 
 
 
 
5. Ethical considerations:  
 
   
      The course of research ethics (CORE) will be completed by the researchers, 
and the study proposal will be submitted for approval to the Queen’s university 
health sciences research ethics board (HSREB). For this research project, we will 
request to waive the informed consent because the intervention involves no 
more than minimal risk to patients. Peripheral IV insertion is a minor common 
procedure, and it is usually conducted by ICU nurses without any form of 
consenting in intubated ICU patients. It is an essential intervention and part of 
the standard of care that carries minimal risk. In addition, It is difficult to carry 
out this research with informed consent because this might affect recruitment 
and feasibility of this study in the ICU setting. The waiver or alteration will not 
adversely affect the rights and welfare of patients. Patients' confidentiality will be 
protected per the Tri-Council Policy Statement: Ethical Conduct for Research 
Involving Humans. The researchers will follow the code of best practices in 
research and declare no conflicts of interest that could affect the outcome of 
the study. 
 
6-Anticipated results/implications: 
 
      We expect that USG-PIVC is more successful in establishing PIVC in difficult 
access ICU patients when performed by highly skilled and experienced ICU 
nurses. Based on previous researchers, we expect that the complications 
associated with this technique to be minor and uncommon. If proven useful, this 
study might popularize the ultrasound-guided technique for insertion of PIVC in 
DIVA patients and help to advance and improves the quality of patient care. 
 
 
7-Funding: 

 
 
 
 
  
 
      For this study, no budget is required. We will use already existing 
hospital resources. Clinical simulation center at the school of medicine in 
Queens University will provide the place and equipment for hands-on 
practice.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8-References 
 
 
 
1- Craig Kornbau, Kathryn C Lee, Gwendolyn D Hughes . Central line 
complications. J Crit Illn Inj Sci. 2015 Jul-Sep; 5(3): 170–178. 
 
2-Randolph AG, Cook DJ, Gonzales CA. Ultrasound guidance for placement of 
central venous catheters: a meta-analysis of the literature. Crit Care Med. 
1996;24:2053-2058. 
 

 
 
 
 
3- Sebbane M, Claret PG, Lefebvre S. Predicting peripheral venous access 
difficulty in the emergency department using body mass index and a clinical 
evaluation of venous accessibility. J Emerg Med 2013; 44:299. 
 
4-Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion 
difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart 
Lung 2005; 34:345.  
 
5-Brannam L, Blaivas M, Lyon M, Flake M. Emergency nurses' utilization of 
ultrasound guidance for placement of peripheral intravenous lines in difficult-
access patients. Acad Emerg Med 2004;11(12):1361–3. 
 
 
6-John Stein, Brian George. Ultrasonographically Guided Peripheral Intravenous 
Cannulation in Emergency Department Patients With Difficult Intravenous 
Access: A Randomised Trial. 
 
7- Costantino TG, Parikh AK, Satz WA. Ultrasonography-guided peripheral 
intravenous access versus traditional approaches in patients with difficult 
intravenous access. Ann Emerg Med 2005;46(5):456–61. 
 
8- Bahl A, Pandurangadu AV. Randomized controlled trial assessing the use of 
ultrasound for nurse-performed IV placement in difficult access ED patients. Am 
J Emerg Med. 2016 Oct;34(10):1950-1954. 
 
9-Gregg SC , Sarah B,  Murthi SB. Ultrasound guided peripheral intravenous 
access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. 
  
10- Kerforne T, Petitpas F, Frasca D. Ultrasound-guided peripheral venous access 
in severely ill patients with suspected difficult vascular puncture. 
Chest, 2012 Jan;141(1):279-280. 

 
 
 
 
 
11-Kuo CC, Wu CY Feng IJ . Efficacy of Ultrasound-Guided Peripheral 
Intravenous Access: A Systematic Review and Meta-Analysis.Hu Li Za Zhi. 2016 
Dec;63(6):89-101. 
 
12-Stolz LA, Cappa AR, Minckler MR. Prospective evaluation of the learning 
curve for ultrasound-guided peripheral intravenous catheter placement. Vasc 
Access. 2016 Jul 12;17(4):366-70. 
 
13- Michael D. Witting,  Stephen M. Schenkel. Effect of vein width and depth on 
ultrasound -guided peripheral intravenous success rates.T he Journal of 
Emergency Medicine. Vol. 39, No. 1, pp. 70–75, 2010 
 
14- J. Matthew Fields , Anthony J. Dean,  Raleigh W. Todman. The effect of 
vessel depth, diameter, and location on ultrasound-guided peripheral 
intravenous catheter longevity. American Journal of Emergency Medicine (2012) 
30, 1131140 . 
 
15- Adhikari S, Blaivas M, Morrison D. Comparison of infection rates among 
ultrasound-guided versus traditionally placed peripheral intravenous lines. J 
Ultrasound Med. 2010;29(5):741-7.  
 
16-Michael Gottlieb,Tina Sundaram, Dallas Holladay ,  Ultrasound-Guided 
Peripheral Intravenous Line Placement: A Narrative Review of Evidence-based 
Best Practices , WestJEM,  volume 18, Issue 6.1, 2017.