PeRfusion Emergency VEiNlite Transillumination (PREVENT)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Toxicomania; Hypotension; Emergencies; Cachexia; Obesity; Hypothermia

Treatments: Device: transillumination dispositif

Study type: Interventional

Funder types: Other

Identifiers

NCT04628975

2020-A00891-38

Details and patient eligibility

About

When taking care of an emergency patient (Emergency Reception Service: UAS and Urgent Medical Assistance Service: SAMU), the installation of a peripheral venous route (VVP) is an important step. The benchmark method is the most widely used technique. This vascular access will allow the necessary therapy to be delivered quickly and efficiently. This can be difficult and sometimes doomed to failure for reasons related both to the patient (venous capital not very visible / felt or limited due to the profile of the patient), or sometimes also for reasons related to the patient. environment (limited lighting, difficult patient access). The only current alternatives lie in the use of a device such as the Intra-Bone Device (IID) or the installation of a central venous line. On the other hand, these alternatives are particularly invasive and / or very algogenic.

There are other techniques, which are more affordable and "transportable" outside the hospital. Indeed, trans-illumination with a very short training seems to be a particularly interesting alternative. It allows, thanks to LEDs in contact with the skin, to backlight the superficial veins.

It is proposed through this project to evaluate this tool for a category of patients considered "difficult" to infuse, both within hospital and outside hospital.

The main objective of the study is to assess the effectiveness of the transillumination device, compared to the absence of such a device, on the placement of a peripheral venous line (PVP) in patients with a difficult vascular approach and managed in the emergency room and whose clinical condition does not require the installation of an intraosseous device.

This is a multicenter, prospective, controlled, randomized and open clinical study, according to a cross-over design. The intervention evaluated is the placement of a PVR using the trans-illumination device. The control intervention is the placement of a PVR without this device, according to the reference method, which is the benchmark method.

400 patients presenting to the emergency room will be included in the centers of Nancy, Toul and Pont-à-Mousson.

Depending on their randomization group, nurses will perform peripheral venous insertion by the transillumination method or by the control method.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

>= 18 years old

• extrem body mass index
• hypotension
• toxicomania
• limited ponction site
• hypotherm patient
• dehydrated patient
• generalized edema
• non-supportive environment

Exclusion criteria

• parturient / pregnant female / breastfeeding mother
• unemancipated minor
• adults under legal protection
• person under judicial protection, guardianship or curatorship

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

with transillumination

Experimental group

Description:

The nurses will use the Transillumination method for a period P1. Then these same nurses will use the control method (without transillumination) for a period P2.

Treatment:

Device: transillumination dispositif

without transillumination (control method)

No Intervention group

Description:

The nurses will use the control method for a period P1. Then these same nurses will use the Transillumination method for a period P2.