An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement
Phase: NA
Conditions: Dislodged Catheter, Catheter Related Complication
Sponsor: Boston Children's Hospital

CHeRP IRB Additional Protocol Information: 
  
In addition to the CHeRP SmartForms, all protocols must include the following sections. 
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TITLE: A novel taping technique for improved intravenous (IV) catheter securement 
VERSION: 7/21/2023  
A. Specific Aims/Objectives 
The primary outcome is to determine the taping method that provides the best 
securement of the catheter (has the maximum force resistance) and the taping method that can 
best withstand a simulated accelerated pull designed to mimic what may occur if a child rapidly 
pulls on the IV tubing or if a provider or family member may accidentally pull or trip on the tubing 
of a novel taping technique for intravenous (IV) securement. This novel technique will be 
compared to two common techniques (over-under and a technique utilized by nursing staff in 
Boston Children’s Hospital’s Emergency Department (BCH ED)).  
B. Background and Significance 
         Up to 90% of all patients require an IV during their hospital visit, yet IV catheters have an 
unacceptable, 35% to 60% failure rate.1-5 Dislodgement is an important contributing factor of IV 
failure, however, there has been minimal research to improve taping techniques. Currently, the 
two most commonly taught and used taping techniques are the over-under (Chevron) and 
horizontal.6,7,8 Unfortunately, these methods have failed to provide adequate securement of the 
IV, leading to complications such as delayed treatments and extended hospitalizations.1,2,5 In a 
prospective study done from June 2018 to March 2019 at Hadassah Medical Center, 40.9% of 
admitted children with peripheral IVs were observed to have complications and 34.6% of these 
complications, the largest percentage, were attributed to dislodgement.5  A cross-sectional 
descriptive survey study collected information from clinicians about the occurrence of accidental 
dislodgement, frequency, and possible impact on activities, among other questions. Over 95% 
of respondents considered dislodgement to be a safety risk and 68% of respondents indicated 
that dislodgements occur often, daily or multiple times every day.9 Moreover, a point of concern 
raised by patients is the pain associated with additional IV insertions. Minimizing this may 
enhance patient experience and overall patient satisfaction. 
         These indications call for urgent change. Not only does dislodgement of IV catheters 
carry clinical significance for patients, it leads to increased workloads for clinicians and 
additional medical costs to families.1 We hypothesize that our novel taping can offer a more 
reliable technique for securing IV catheters, granting a reduction in both treatment interruptions 
and extended hospital stays. 

C. Preliminary Studies 
         In 2017, Stace et al. compared the security of horizontal and over-under techniques by 
measuring the mean force to dislodge a catheter from staff volunteers.6 Patel et al. had two 
related publications. The first examined the effectiveness of different combinations of tape types 
and taping methods by measuring the pullout force of an IV. One of the limitations of this study 
was the utilization of a PVC pipe to mimic the forearm instead of human subjects. The second 
publication was similar but reported on the force required to dislodge an IV with various tapes 
and skin preparations.7,8 Found et al. compared different taping methods using locally available 
tapes to determine the dislodgement force required to detach IVs from a PVC pipe.10 The latter 
three were published in 1994, 1995, and 2000, respectively, warranting updated research. 
Moreover, it should be noted that Patel’s studies were completed in the United States, whereas 
Found’s study was in Australia, highlighting this as a global concern.  
Although the literature surrounding specific taping techniques are limited, several 
dressing studies have been published. Most recently, a study at the University of Freidburg 
Medical Center examined dislodgement forces and cost effectiveness of four different types of 
dressings, which showed the combination of sterile gauze and elastic polyester fleece to be 
most effective.4 SAVE, a pragmatic, randomized controlled, superiority trial conducted at two 
institutions in Queensland, Australia, described no difference between the four different dressing 
types studied with a peripheral IV failure rate of 38-43%.3 A limitation of these studies is the 
unmodified use of the horizontal and over-under techniques, which our novel taping plans to 
address. 
Lastly, there have been retrospective reviews advocating for additional research to be 
pursued. Most notably, Helm et al. and Corley et al. stressed the opportunities that lie with 
persistent high rates of IV failures.1,2 Jackson held an audit of peripheral venous catheter (PVC) 
restarts at one institution, during August-October 2010 v. August-October 2011. An internal 
review of 6500 peripheral catheters showed 36% of catheters failed due to dislodgement. 
Between the two years, the securement methodology was modified at the institution, leading to 
a reduction of dislodgement, leakage, and infiltration factors. The modification also led to a 
drastic increase (factor of 2.94) of catheters lasting at least 72 hours.11 The call-to-actions 
coupled with a lack of innovation around taping methods signify a dire need of any solution, 
which this novel taping hopes to address.  
D. Design and Methods 
(1)     Study Design 
This is a prospective, single-blinded, randomized research study that will take place at 
Boston Children’s Hospital (BCH). 
(2)     Patient Selection and Inclusion/Exclusion Criteria 
Inclusion criteria: Staff from Boston Children’s Hospital who have volunteered to participate. 

Exclusion criteria: Individuals under the direct supervision of any study investigators, individuals 
with excessive hair in the AC on either arm (which may cause pain to the subject), individuals 
with fragile and/or non-intact skin in the AC region, individuals who have already participated 
(no re-enrollments), adhesive allergies, and individuals who decline to participate. 
(3)     Description of Study Treatments or Exposures/Predictors 
 A member of the study team will identify staff volunteers of varying age, race, and sex to 
participate in the study. Verbal consent will be obtained and a time and location to carry out 
study procedures will be confirmed. Subjects will have measurements captured with 3 different 
taping methods (BCH-ED, over-under, and novel) in 2 unique directions (retrograde and 90-
degrees), totaling 6 measurements. 
With the staff volunteer sitting in an up-right position with their elbow bent at a 90-degree 
angle, a research staff member will attach an IV catheter to the subject’s anterior cubital (AC) 
fossa but will not puncture the skin. The IV catheter will only be taped superficially on the 
subject’s skin to simulate IV placement. The taping method of choice (BCH ED, over-under, or 
novel)will be applied based on the randomized schedule. The randomization scheme will be 
provided by department biostatistician, Steven Staffa. A towel will be placed over the AC region, 
blinding the research team member who will be measuring the force to the taping technique 
(Fig. 1).  
 
Fig. 1. IV Catheter placed on subject’s AC with taping method/towel positioning.  
Once covered, a second researcher will enter the room to assist with dislodgement 
procedures. Maximum force measurements will be collected using the Shimpo FGV-100XY 

Digital Force Gauge, 100 lbs. The gauge comes with an attached hook as used in Stace et al. 
that can hook onto the IV (Fig. 2).6  
 
Fig. 2. Force transducer and IV catheter attached.  
Once hooked, the second researcher will crank the handle until the force gauge 
measurement drops which signifies that the catheter has dislodged and/or the tape is removed 
from the (Fig. 3). These steps will be repeated using the remaining taping methods and 
directions. 
 
 
Fig. 3. Force transducer and hand wheel test stand.  

 (4)     Definition of Primary and Secondary Outcomes/Endpoints 
Our primary outcome is to determine the taping method that provides the best 
securement of the catheter: i.e., has the maximum force resistance Moreover, it is to determine 
the taping method that can best withstand a simulated accelerated pull designed to mimic what 
may occur if a child rapidly pulls on the IV tubing or if a provider or family member may 
accidentally pull or trip on the tubing. 
(5)     Data Collection Methods, Assessments, Interventions and Schedule (what 
assessments performed, how often) 
Data will be collected in real time, utilizing the Shimpo FGV-100XY Digital Force Gauge, 
100 lbs. and recorded on a case report form (CRF). The Shimpo FGV-100XY Digital Force 
Gauge will provide a maximum force of each recording and be zeroed prior to new data 
collection. The maximum force measurement is frozen on the screen until zeroed again, 
preventing any data ambiguity or loss. Table 1 (below) shows how our data will be collected.  
Subject ID: 
Taping Methodology 
 
 
 
Novel 
BCH ED 
Over-Under 
Retrograde Force (N) 
 
 
 
             AC region (right/left) 
 
 
 
90 Degrees Force (N) 
 
 
 
             AC Region (right/left) 
 
 
 
Table 1. Example of CRF  
 (6)    Study Timeline (as applicable) 
We will recruit subjects over a period of 6 months. Although only 30 subjects are needed 
for data analysis, our target will be to recruit up to 40 subjects within the same period to account 
for any withdrawn. 
E. Adverse Event Criteria and Reporting Procedures 
We do not anticipate any adverse events as this is a minimal risk study, but any adverse 
events would be reported to the necessary groups per BCH and IRB guidelines. 
F. Data Management Methods 
   
Data collected from the Shimpo FGV-100XY Digital Force Gauge, 100 lbs. will be 
manually recorded in real time on a CRF and any electronic storage will be within the BCH 

network. Study ID numbers will be assigned to each participant, and results will be de-identified. 
Only research members will have the ability to link the ID number with identifiable information. 
G. Quality Control Method 
         A member of the research team will complete periodic audits to assure data accuracy 
and quality. Data will be verified by the investigator prior to analysis. 
H. Data Analysis Plan 
Calculations will be based on a two-tailed Student’s t-test for an effect size of 1 standard 
deviation. Stata 13.2 will be used for data analysis (StataCorp, College Station, TX). 
I. Statistical Power and Sample Considerations 
          Based on the work of Stace et al. and the assistance of Steven Staffa (Anesthesia 
Department Biostatician), power calculations yielded a total sample size of 30 participants to 
demonstrate a difference of 1 standard deviation with a power of 90%.6 We plan to recruit 40 
volunteer subjects to account for potential dropouts. 
J. Study Organization 
The principal investigator for this study will be Dr. Pete Kovatsis, an Attending 
Anesthesiologist at Boston Children’s Hospital. 
K. References 
1. Helm, R, Klausner, J, Klemperer, J, Flint, L, Huang, E. Accepted but Unacceptable, 
Journal of Infusion Nursing: 2015 May;38(3):189-203 
2. Corley A, Marsh N, Ullman AJ, Rickard CM. Peripheral intravenous catheter 
securement: An integrative review of contemporary literature around medical adhesive 
tapes and supplementary securement products. J Clin Nurs. 2022 Feb 3;Epub ahead of 
print. 
3. Rickard, C. M., Webster, J., Wallis, M. C., Marsh, N., McGrail, M. R., French, V., Foster, 
L., Gallagher, P., Gowardman, J. R., Zhang, L., McClymont, A., & Whitby, M. Routine 
versus clinically indicated replacement of peripheral intravenous catheters: a 
randomised controlled equivalence trial. Lancet (London, England): 2012; 380(9847): 
1066–1074. 
4. Schmutz, A., Menz, L., Schumann, S., & Heinrich, S. Dislodgement Forces and Cost 
Effectiveness of Dressings and Securement for Peripheral Intravenous Catheters: A 
Randomized Controlled Trial. Journal of clinical medicine: 2020; 9(10), 3192. 
5. Resnick, O, Abu Ahmad, W, Bancovsky, D, et al. Predicting factors for complications in 
peripheral intravenous catheters in the pediatric population. Acta Paediatr. 2021; 
110:1639–1644. 
6. Stace S, Symes M, Gillett M. A Comparison of Two Commonly Used Methods for 
Securing Intravenous Cannulas. J Acute Med. 2017 Jun 1;7(2):61-66. 

7. Patel N, Smith CE, Pinchak AC, Hancock DE. Evaluation of different methods of 
securing intravenous catheters: measurement of forces during simulated accidental 
pullout. Can J Anaesth. 1995 Jun;42(6):504-10. 
8. Patel, N., Smith, C. E., Pinchak, A. C., & Hancock, D. E. The influence of tape type and 
of skin preparation on the force required to dislodge angiocatheters. Canadian journal of 
anaesthesia = Journal canadien d'anesthesie, 1994;41(8), 738–741. 
9. Moureau, N. Impact and Safety Associated with Accidental Dislodgement of Vascular 
Access Devices: A Survey of Professions, Settings, and Devices. Journal of Association 
for Vascular Access, 2018; 23(4):203-215. 
10. Found PW, Baines DB. Efficacy of securing cannulae with different taping methods. 
Anaesth Intensive Care. 2000 Oct;28(5):547-51. 
11. Jackson, A. Retrospective comparative audit of two peripheral IV securement dressings. 
British Journal of Nursing, 2013; 21(2):S16-20. 
* If you are an investigator submitting an IND or IDE, this document alone does not constitute 
and complete protocol. You must submit your full IND/IDE application as an attachment for this 
section.