GLUEPED2024: Study on the Use of Peripheral Venous Catheters in Pediatric Patients With Emergency Room Access.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cyanoacrylate glue.
- Who it may be relevant to
- Registry conditions: Venous Catheterization. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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.
Overview
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.
Interventions
- Procedure cyanoacrylate glue
Tissue adhesive to properly seal the venipuncture site and fix the catheter optimally to limit the risk of complications.
Primary outcome measures
- Number of dislocations of the vascular access device (VADs) [Time frame: 6 hours post- VADs insertion]
Secondary outcome measures (3)
- Number of dislocations of the vascular access device (VADs) [Time frame: 12, 24, 36, 48, and 72 hours post- VADs insertion]
- Change in Visual Exit Site (VES) score [Time frame: 6, 12, 24, 36, 48, and 72 hours post- VADs insertion]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Meyer Children's Hospital IRCCS, Firenze — Florence
Identifiers
NCT: NCT07450729 · GLUEPED2024