GLUEPED2024: Study on the Use of Peripheral Venous Catheters in Pediatric Patients With Emergency Room Access.

Randomized, Open-label, Parallel-arm, Controlled Study to Evaluate the Stabilization of Peripheral Venous Catheters Through the Application of Cyanoacrylate Skin Adhesive to the Exit Site in Pediatric Patients With Emergency Room Access.

A venous access device (VADs) is a biocompatible plastic catheter that establishes a connection between the skin surface and a venous system. They can be categorized using various classifications; notably, based on the position of the catheter tip, they are distinguished into central venous catheters (CVCs) and peripheral venous catheters (PVCs). Depending on their length, PVCs can be further divided into long-cannula PVCs and short-cannula PVCs.

Currently, these catheters are stabilized "in situ" using transparent semipermeable dressings with a high moisture vapor transmission rate (MVTR), which keep the insertion site visible. Considering the pediatric patient population, this type of stabilization is currently somewhat archaic, and accidental displacement of PVCs is frequently encountered, along with subsequent complications such as extravasation, occlusion, phlebitis, and local infections.

The addition of skin glue to the transparent semipermeable dressing ensures optimal stabilization of the device, reducing dislodgement, further complications, and consequently the need for multiple punctures for repositioning.

Due to various clinical conditions, some patients presenting to the Emergency Department have a venous network that is difficult to identify by direct visualization or palpation. In these patients, the occurrence of an accidental displacement would significantly compromise the quality of care. Currently, there are no studies in the literature conducted in a pediatric emergency department that demonstrate the superiority of using cyanoacrylate glue for PVC stabilization compared to the semipermeable dressing alone. This study aim to investigate the use of cyanoacrylate glue for stabilizing venous access devices in the emergency setting as well, and to evaluate potential improvements to current daily clinical practice.

The primary objective is to evaluate whether applying cyanoacrylate skin glue at the exit site provides better stabilization of a correctly placed peripheral venous catheter (PVC) compared to PVC stabilization with a transparent semipermeable dressing alone.

Study Overview

• Status: Recruiting
• Conditions: Venous Catheterization
• Intervention / Treatment: Procedure: cyanoacrylate glue

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulia Caccia, Principal Investigator; Phone Number: 0555662629; Email: giulia.caccia@meyer.it

Study Locations

• Italy
  • Florence, Italy
    • Recruiting
    • Meyer Children's Hospital IRCCS, Firenze
    • Contact: Giulia Caccia, Nurse; Phone Number: +390555662629; Email: giulia.caccia@meyer.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 0-18 years old
• Venous access device for at least 24 hours.
• Informed consent form signed

Exclusion Criteria:

• Patients with language barriers
• patients with pre-existing central venous access
• patients requiring immediate surgery with venous access placed under sedation
• skin lesions in the affected area
• patients exhibiting psychomotor agitation
• patients assigned to the emergency code
• unaccompanied minors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Procedure: cyanoacrylate glue; Tissue adhesive to properly seal the venipuncture site and fix the catheter optimally to limit the risk of complications.
No Intervention: Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of dislocations of the vascular access device (VADs)	6 hours post- VADs insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of dislocations of the vascular access device (VADs)		12, 24, 36, 48, and 72 hours post- VADs insertion
Change in Visual Exit Site (VES) score	Analysis of the frequency of complications	6, 12, 24, 36, 48, and 72 hours post- VADs insertion
Correlation between the percentage of displacement of venous access device and DIVA score.		6, 12, 24, 36, 48, and 72 hours post- VADs insertion

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: MK 6 cyanoacrylate
• Other Study ID Numbers: GLUEPED2024

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