PeRfusion Emergency VEiNlite Transillumination (PREVENT)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Emergencies; Hypotension; Hypothermia; Cachexia; Toxicomania
• Intervention / Treatment: Device: transillumination dispositif

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients for whom peripheral venous vein placement was successful on the first attempt	immediately after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Catherine Staszewski, CH Pont à Mousson

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (ACTUAL): November 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: adult; emergency; peripheral venous approach; transillumation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Body Weight; Body Weight Changes; Body Temperature Changes; Emaciation; Weight Loss; Emergencies; Hypotension; Hypothermia; Cachexia
• Other Study ID Numbers: 2020-A00891-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No