Infrared for Peripheral Venous Catheterization in the Critically-ill

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Venous Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be divided into two groups with a 1: 1 ratio. Each patient will be assigned to one of the following 2 arms:

\- Usual technique : Visualization of the vein to be catheterized will be done directly. without infrared illumination.

or

-Use of the Accuvein® device: Visualization of the vein to be catheterized will be done with infrared illumination.

In both groups, catheterization will be carried out according to the usual technique in accordance with the recommendations.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infrared illumination group

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

Group Type EXPERIMENTAL

ACCUVEIN

Intervention Type DEVICE

The nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ACCUVEIN

The nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device.

Intervention Type DEVICE

Eligibility Criteria

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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