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

NCT07450729 | Recruiting

• 1 other identifier: GLUEPED2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Catheterization

Outcome Measures

Primary Outcomes (1)

• Number of dislocations of the vascular access device (VADs)

  6 hours post- VADs insertion

Secondary Outcomes (3)

• 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

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

Procedure: cyanoacrylate glue

Standard of care

NO INTERVENTION

Interventions

cyanoacrylate glue PROCEDURE

Tissue adhesive to properly seal the venipuncture site and fix the catheter optimally to limit the risk of complications.

Experimental group

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital IRCCS, Firenze

Florence, Italy

RECRUITING

MeSH Terms

Interventions

MK 6 cyanoacrylate

Central Study Contacts

Giulia Caccia, Principal Investigator

CONTACT

0555662629; giulia.caccia@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 5, 2026
• Study Start: January 14, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)