Infrared for Peripheral Venous Catheterization in the Critically-ill

Not Applicable

Recruiting

• Conditions: Peripheral Venous Catheterization
• Interventions: Device: ACCUVEIN

• Registration Number: NCT03932214
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications.

Venous access difficulties are frequent in critically-ill patients. Among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. Infrared illumination has never been evaluated in intensive care. However, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. Our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique The objective is to evaluate the interest of infrared illumination (AccuVein AV500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult.

It is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase III trial. Subjects will be divided into two groups with a 1: 1 ratio. Nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-30
• Study Start: 2019-12-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• Age ≥ 18 years; Hospitalization in intensive care;
• Need for a peripheral venous catheter;
• Risk of difficult peripheral venous catheterization. In practice, this risk will be considered present if it is impossible to palpate and / or visualize the upper end of the target vein and / or if the estimated vein diameter is smaller than 2mm. This definition is derived from the A-DIVA score (Loon FAJ van et al3).
• Affiliation to the social security

Exclusion Criteria

• Patient who has already been enrolled in the ICARE study during the current hospitalization;
• Refusal of patient's participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infrared illumination group	ACCUVEIN	The nurse uses the Accuvein® device to identify the veins before puncture.

Primary Outcome Measures

Name	Time	Method
Percentage of primary success of peripheral venous catheterization in the upper limbs.	Day 1	success defined as the need of a single puncture for the effective catheterization.; The effective catheterization is confirmed by obtaining venous reflux by declivity of the infusion bag.

Secondary Outcome Measures

Name	Time	Method
Number of punctures required for peripheral venous catheterization.	Day 1
Rate of failure of the procedure, defined by the absence of placement of a peripheral venous catheter before the end of the procedure	Day 1

Trial Locations

Locations (1)

Henri-Mondor Hospital; 🇫🇷 Créteil, Val De Marne, France