PeRfusion Emergency VEiNlite Transillumination

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2022

Interventions

  • Device: transillumination dispositif
    • infrared light

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • number of attempts before successful venous line placement
    • Time Frame: during the procedure
  • patient pain
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: during the procedure
    • measured by the type of catheter gauge used

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Catherine Staszewski, Principal Investigator, CH Pont à Mousson
  • Overall Contact(s)
    • Julie Lecomte, 0383155278, ju.lecomte@chru-nancy.fr

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