Infrared for Peripheral Venous Catheterization in the Critically-ill (ICARE)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Peripheral Venous Catheterization

Treatments: Device: ACCUVEIN

Study type: Interventional

Funder types: Other

Identifiers

NCT03932214

PHRIP-18-0617

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 2 patient groups

Infrared illumination group

Experimental group

Description:

The nurse uses the Accuvein® device to identify the veins before puncture.

Treatment:

Device: ACCUVEIN

Control group

No Intervention group

Description:

The nurse proceeds as usual (visual identification in the light of the room and palpation)