PREVENT: PeRfusion Emergency VEiNlite Transillumination

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT04628975

Collaborator

(none)

400

Enrollment

Arms

17.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Emergencies Toxicomania Hypotension Obesity Cachexia Hypothermia	Device: transillumination dispositif	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

multi-center prospective randomized cross-over studymulti-center prospective randomized cross-over study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Evaluation of the Efficacy of Transillumination on Peripheral Venous Line Placement in Patients With a Difficult Vascular Approach Who Are Managed in the Emergency Department.

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: with transillumination 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.	Device: transillumination dispositif infrared light
No Intervention: without transillumination (control method) The nurses will use the control method for a period P1. Then these same nurses will use the Transillumination method for a period P2.

Arm

Intervention/Treatment

Experimental: with transillumination

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.

Device: transillumination dispositif

infrared light

No Intervention: without transillumination (control method)

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

Outcome Measures

Primary Outcome Measures

Percentage of patients for whom peripheral venous vein placement was successful on the first attempt [immediately after procedure]

Secondary Outcome Measures

number of attempts before successful venous line placement [during the procedure]
patient pain [during the procedure]
The patient's pain is measured by the digital pain scale (scale ranging from 0 (no pain) to 10 (intolerable pain)).
nurse stress [during the procedure]
Nurse stress is measured by the digital stress scale (scale ranging from 0 (no stress) to 10 (intolerable stress)).
The caliber of the peripheral venous route [during the procedure]
measured by the type of catheter gauge used