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

NCT ID: NCT05948878

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2023-11-09

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.

Conditions

Dislodged Catheter; Catheter Related Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Novel Taping Method

Intervention Type: 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.

BCH Emergency Department Taping Method

Intervention Type: 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.

Chevron Taping Method

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Novel Taping Method

Intervention Type: 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.

BCH Emergency Department Taping Method

Intervention Type: 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.

Chevron Taping Method

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pete Kovatsis

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pete Kovatsis, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00043126

Identifier Type: -

Identifier Source: org_study_id