PeRfusion Emergency VEiNlite Transillumination

NCT04628975 | Unknown

• 1 other identifier: 2020-A00891-38
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emergencies; Toxicomania; Hypotension; Obesity; Cachexia; Hypothermia

Keywords

adult; peripheral venous approach; emergency; transillumation

Outcome Measures

Primary Outcomes (1)

• Percentage of patients for whom peripheral venous vein placement was successful on the first attempt

  immediately after procedure

Secondary Outcomes (4)

• number of attempts before successful venous line placement

  during the procedure

• patient pain

  during the procedure

• nurse stress

  during the procedure

• The caliber of the peripheral venous route

  during the procedure

Study Arms (2)

with transillumination

EXPERIMENTAL

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

without transillumination (control method)

NO INTERVENTION

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

Interventions

transillumination dispositif DEVICE

infrared light

with transillumination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 years old
• extrem body mass index
• hypotension
• toxicomania
• limited ponction site
• hypotherm patient
• dehydrated patient
• generalized edema
• non-supportive environment

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Emergencies; Hypotension; Obesity; Cachexia; Hypothermia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Weight Loss; Body Weight Changes; Thinness; Body Temperature Changes

Study Officials

• Catherine Staszewski

  CH Pont à Mousson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Lecomte

CONTACT

0383155278; ju.lecomte@chru-nancy.fr

Catherine Staszewski

CONTACT

cathpam@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multi-center prospective randomized cross-over study

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 16, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 16, 2020

Record last verified: 2020-08