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

NCT05948878 | Completed Results FDA Device

• 1 other identifier: IRB-P00043126
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dislodged Catheter; Catheter Related Complication

Keywords

Catheter Taping Methods; Catheter securement; Catheters; Intravenous catheters

Outcome Measures

Primary Outcomes (2)

• The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction.

  We will examine the maximum force the 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 in a 90 Degrees Direction.

  We will examine the maximum force the 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

Study Arms (2)

Retrograde Directional Test

ACTIVE COMPARATOR

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; Device: BCH Emergency Department Taping Method; Device: Chevron Taping Method

90 Degrees Directional Test

ACTIVE COMPARATOR

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; Device: BCH Emergency Department Taping Method; Device: Chevron Taping Method

Interventions

Novel Taping Method DEVICE

Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.

90 Degrees Directional Test; Retrograde Directional Test

BCH Emergency Department Taping Method DEVICE

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.

90 Degrees Directional Test; Retrograde Directional Test

Chevron Taping Method DEVICE

Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.

90 Degrees Directional Test; Retrograde Directional Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Employees of Boston Children's Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Results Point of Contact

• Title: Pete Kovatsis
• Organization: Boston Children's Hospital

pete.kovatsis@childrens.harvard.edu

617-355-6225

Study Officials

• Pete Kovatsis, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The research team member placing the tape was blinded from the measurements obtained, and the research team member obtaining the measurements was blinded from the tape that was placed.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: July 17, 2023
• Study Start: July 28, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)