An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement

This is a prospective, single-blinded, randomized study to assess the ability of taping methods used to secure intravenous (IV) catheters to resist the IV from being pulled away from the skin. Participants will have IV catheters taped on top of the skin (without insertion into the skin) using three taping methods, BCH Emergency Department (BCH ED), Chevron, and our novel method. Six measurements will be obtained per subject (3 random taping methods measuring their resistance to force in two directions, retrograde direction or towards the wrist and 90-degree angle to the arm).

Study Overview

• Status: Completed
• Conditions: Catheter Related Complication; Dislodged Catheter
• Intervention / Treatment: Device: Novel Taping Method; Device: BCH Emergency Department Taping Method; Device: Chevron Taping Method

Detailed Description

Accidental removal of IV catheters delay patient care and can cause additional medical anxiety and pain that is heightened in the pediatric population. Moreover, such failed catheters create an increased burden economically and emotionally to patients, hospitals, and clinicians. To facilitate the most accurate, consistent results, a calibrated hand wheel test stand with a force gauge will be used to obtain force measurements. We will obtain the amount of force is required to remove the IV catheter form the skin of the subjects to compare the three taping measurements in two different directions. The retrograde direction will be pulling the IV distally from the IV site, towards the participant's wrist. The 90-degree angle will be pulling the IV medially away from the IV site.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pete Kovatsis, MD; Phone Number: 617-355-7737; Email: pete.kovatsis@childrens.harvard.edu
• Study Contact Backup: Name: Samuel Kim; Phone Number: 617-919-3692; Email: samuel.kim@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Employees of Boston Children's Hospital

Exclusion Criteria:

• Individuals under the direct supervision of any study investigators
• Individuals with excessive hair in/near the antecubital fossa region on either arm
• Individuals with fragile and/or non-intact skin in/near the antecubital fossa region
• Individuals who have adhesive allergies
• Individuals who have already participated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Retrograde Directional Test; Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.	Device: Novel Taping Method; Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.; Device: BCH Emergency Department Taping Method; Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.; Device: Chevron Taping Method; Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
Active Comparator: 90 Degrees Directional Test; Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.	Device: Novel Taping Method; Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.; Device: BCH Emergency Department Taping Method; Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.; Device: Chevron Taping Method; Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Force (Newtons) Required to Dislodge an IV Catheter Secured by the Chevron, BCH ED, and Novel Taping Methods Using a Force Gauge in the retrograde direction.	We will examine the maximum force the Chevron, BCH ED, and Novel taping methods can withstand as measured by the force gauge in the retrograde direction, distally from the insertion site.	Until the tape is dislodged- approximately 15 seconds
The Force (Newtons) Required to Dislodge an IV Catheter Secured by the Chevron, BCH ED, and Novel Taping Methods Using a Force Gauge in a 90 degrees direction.	We will examine the maximum force the Chevron, BCH ED, and Novel taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site.	Until the tape is dislodged- approximately 15 seconds

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Pete Kovatsis, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Catheters; Catheter Taping Methods; Catheter securement; Intravenous catheters
• Other Study ID Numbers: IRB-P00043126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No