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NCT Number: NCT07450729

GLUEPED2024: Study on the Use of Peripheral Venous Catheters 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.

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Key information

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meyer Children's Hospital IRCCS, Firenze

Florence, Italy

Location status: Recruiting

Location contact

Giulia Caccia, Nurse

CONTACT

[email protected]

+390555662629

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyanoacrylate glue

Procedure

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

Primary outcomes

  1. Number of dislocations of the vascular access device (VADs)

    Time frame: 6 hours post- VADs insertion

Secondary outcomes

  1. Number of dislocations of the vascular access device (VADs)

    Time frame: 12, 24, 36, 48, and 72 hours post- VADs insertion

  2. Change in Visual Exit Site (VES) score

    Time frame: 6, 12, 24, 36, 48, and 72 hours post- VADs insertion

    Analysis of the frequency of complications

  3. Correlation between the percentage of displacement of venous access device and DIVA score.

    Time frame: 6, 12, 24, 36, 48, and 72 hours post- VADs insertion

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Caccia, Principal Investigator

CONTACT

[email protected]

0555662629

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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