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

Catheter Related Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05948878
• Other study ID #: IRB-P00043126
• Status: Completed
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: November 9, 2023

Study information

• Verified date: January 2024
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Complication
• Dislodged Catheter

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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