Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology

Not Applicable

Recruiting

• Conditions: Neonatology; Newborns; Intensive Care
• Interventions: Device: Insertion of peripheral venous catheter with micro-guide; Other: Classic insertion of peripheral venous catheter, without micro-guide

• Registration Number: NCT04984967
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Peripheral venous catheterization represents the preferential option for term or preterm infant care in order to start drug treatment or hydration, or perform anesthesia.

However, the peripheral venous access is associated in approximately 50% of cases with a failure of the insertion on the first attempt in an emergency context. Using a micro-guide may facilitate the peripheral venous catheterization in newborns, by guiding the catheter in the vein and, thereby reduce the risk of transfixion of the vascular lumen.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-08-02
• Study Start: 2021-12-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital

Exclusion Criteria

• Term neonate > 28 days
• Premature neonate > 41 weeks of corrected gestational age
• Exclusive requirement for an umbilical venous catheter, in the context of neonatal resuscitation
• Exclusive requirement for an epicutaneous-cava catheter, in the context of prolonged parenteral nutrition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insertion of peripheral venous catheter with micro-guide	Insertion of peripheral venous catheter with micro-guide	-
Classic insertion of peripheral venous catheter, without micro-guide	Classic insertion of peripheral venous catheter, without micro-guide	-

Primary Outcome Measures

Name	Time	Method
Success of peripheral venous catheterization at the first attempt	Up to 5 minutes after the success of the placement	The success of the placement is defined by the arrival of blood in the transparent chamber downstream of the needle during the placement, and by the absence of painful reaction and edema near the insertion site, indicating extravasation or extravascular passage, after flushing the catheter with 0.5 to 1 ml of isotonic saline. The success will be confirmed by retesting flush after securing the peripheral venous catheter in a dressing, within 3 to 5 minutes of successful puncture.

Secondary Outcome Measures

Name	Time	Method
Efficiency of the technique	Up to 4 days.	Assessed by the reason for removal of peripheral venous catheter (ie, elective removal or removal for the occurrence of adverse events, see below).
Adverse events	Up to 1 month.	Common to the placement of any peripheral venous catheter, regardless of the insertion technique : puncture of an artery, pain, hemorrhage at the puncture site, phlebitis, thrombosis, infection, obstruction and subcutaneous diffusion of the infusion.

Trial Locations

Locations (1)

University Hospital Montpellier; 🇫🇷 Montpellier, France