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Recruiting Not applicable

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

NCT07450729 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-01-14
Last updated
2026-03-05

Condition(s) studied

Venous Catheterization

Investigational drug(s) / intervention(s)

cyanoacrylate glue

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

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of dislocations of the vascular access device (VADs) — 6 hours post- VADs insertion

Trial sites (1)

FacilityCityRegionStatus
Meyer Children's Hospital IRCCS, Firenze Florence Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07450729 on ClinicalTrials.gov ↗ ← All trials in Italy