CClinicalTrials.gg
RecruitingNCT07450729Updated Mar 5, 2026

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

An interventional study of cyanoacrylate glue in Venous Catheterization, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 1 site in Italy. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Meyer Children's Hospital IRCCS · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2025, registered Feb 2026).
  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
0 Years to 18 Years
Sex
All
01

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.

02

Conditions studied

  • Venous Catheterization
03

In context

Lead sponsor

Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Procedure: cyanoacrylate glue

  • No intervention
    Standard of care

Interventions

  • Procedurecyanoacrylate glue

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

06

What researchers measure

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

    Analysis of the frequency of complications

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

  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

07

Study locations

1 of 1 sites recruiting
  • Meyer Children's Hospital IRCCS, Firenze
    Florence, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07450729
Lead sponsor
Meyer Children's Hospital IRCCS
Responsible party
Giulia Caccia (MD, Meyer Children's Hospital IRCCS) — Principal investigator
First posted
Mar 5, 2026
Start date
Jan 14, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

Giulia Caccia, Principal Investigator
Contact
giulia.caccia@meyer.it
0555662629

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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