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

Not Applicable

Completed

• Conditions: Dislodged Catheter; Catheter Related Complication
• Interventions: Device: Novel Taping Method; Device: BCH Emergency Department Taping Method; Device: Chevron Taping Method

• Registration Number: NCT05948878
• Lead Sponsor: Boston Children's Hospital

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).

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 Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-17
• Study Start: 2023-07-28
• Primary Completion: 2023-11-09
• Study Completion: 2023-11-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retrograde Directional Test	BCH Emergency Department Taping Method	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.
90 Degrees Directional Test	Novel Taping Method	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.
Retrograde Directional Test	Novel Taping Method	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.
90 Degrees Directional Test	BCH Emergency Department Taping Method	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.
90 Degrees Directional Test	Chevron Taping Method	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.
Retrograde Directional Test	Chevron Taping Method	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.

Primary Outcome Measures

Name	Time	Method
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.	Until the tape is dislodged- approximately 15 seconds	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.
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.	Until the tape is dislodged- approximately 15 seconds	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States