PeRfusion Emergency VEiNlite Transillumination

Obesity Clinical Trial

— PREVENT  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04628975
• Other study ID #: 2020-A00891-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: July 2022

Study information

• Verified date: August 2020
• Source: Central Hospital, Nancy, France
• Contact: Julie Lecomte
• Phone: 0383155278
• Email: ju.lecomte[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Emergencies
• Hypotension
• Hypothermia
• Obesity
• Toxicomania

Intervention

Device:
• transillumination dispositif
infrared light

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients for whom peripheral venous vein placement was successful on the first attempt		immediately after procedure
Secondary	number of attempts before successful venous line placement		during the procedure
Secondary	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
Secondary	nurse stress	Nurse stress is measured by the digital stress scale (scale ranging from 0 (no stress) to 10 (intolerable stress)).	during the procedure
Secondary	The caliber of the peripheral venous route	measured by the type of catheter gauge used	during the procedure