Clinical trial NCT04628975: PeRfusion Emergency VEiNlite Transillumination
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergencies
Toxicomania
Hypotension
Obesity
Cachexia
Hypothermia
Keywords: adult
peripheral venous approach
emergency
transillumation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center prospective randomized cross-over study
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients for whom peripheral venous vein placement was successful on the first attempt
timeFrame: immediately after procedure
Secondary outcomes:
measure: number of attempts before successful venous line placement
timeFrame: during the procedure
measure: patient pain
timeFrame: during the procedure
measure: nurse stress
timeFrame: during the procedure
measure: The caliber of the peripheral venous route
timeFrame: during the procedure
Other outcomes:
Locations:
Study officials:
affiliation: CH Pont à Mousson
name: Catherine Staszewski
role: PRINCIPAL_INVESTIGATOR
References: