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

Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care; Newborns; Neonatology
• Intervention / Treatment: Device: Insertion of peripheral venous catheter with micro-guide; Other: Classic insertion of peripheral venous catheter, without micro-guide

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles CAMBONIE; Phone Number: 04 67 33 65 56; Email: g-cambonie@chu-montpellier.fr
• Study Contact Backup: Name: Vincent BRODEAU; Phone Number: 04 67 33 66 09; Email: v-brodeau@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • University Hospital Montpellier
    • Contact: Vincent BRODEAU, MD; Phone Number: +33 467336609; Email: v-brodeau@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insertion of peripheral venous catheter with micro-guide	Device: Insertion of peripheral venous catheter with micro-guide; After antisepsis, the vein is punctured using a needle. Then the micro-guide is inserted to the first landmark, which indicates the passage of the micro-guide beyond the end of the needle. After the needle removed, the peripheral venous catheter is placed on the micro-guide. The guide is then removed, the peripheral venous catheter can be used.
Other: Classic insertion of peripheral venous catheter, without micro-guide	Other: Classic insertion of peripheral venous catheter, without micro-guide; After antisepsis, the catheter is introduced into the vein by a needle which is subsequently removed while the catheter remains in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of peripheral venous catheterization at the first attempt	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.	Up to 5 minutes after the success of the placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Specifically associated with the micro-guide: section, intravascular migration, venous transfixion.	Up to 4 days.
Adverse events	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.	Up to 1 month.
Efficiency of the technique	Assessed by the number of venipuncture attempts.	Up to 4 days.
Efficiency of the technique	Assessed by the duration of the installation (time from the end of skin asepsis to the end of the occlusive dressing).	Up to 4 days.
Efficiency of the technique	Assessed by the requirement to insert a central venous line directly linked to failure of peripheral venous catheterization.	Up to 4 days.
Efficiency of the technique	Assessed by the reason for removal of peripheral venous catheter (ie, elective removal or removal for the occurrence of adverse events, see below).	Up to 4 days.

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care; vascular access; Peripheral intravenous catheterization; Newborn infant
• Other Study ID Numbers: RECHMPL20_0410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No