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PeRfusion Emergency VEiNlite Transillumination (PREVENT)

Primary Purpose

Emergencies, Toxicomania, Hypotension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transillumination dispositif
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergencies focused on measuring adult, peripheral venous approach, emergency, transillumation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    with transillumination

    without transillumination (control method)

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    number of attempts before successful venous line placement
    patient pain
    The patient's pain is measured by the digital pain scale (scale ranging from 0 (no pain) to 10 (intolerable pain)).
    nurse stress
    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
    measured by the type of catheter gauge used

    Full Information

    First Posted
    October 21, 2020
    Last Updated
    November 9, 2020
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04628975
    Brief Title
    PeRfusion Emergency VEiNlite Transillumination
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emergencies, Toxicomania, Hypotension, Obesity, Cachexia, Hypothermia
    Keywords
    adult, peripheral venous approach, emergency, transillumation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    multi-center prospective randomized cross-over study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    with transillumination
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    without transillumination (control method)
    Arm Type
    No Intervention
    Arm Description
    The nurses will use the control method for a period P1. Then these same nurses will use the Transillumination method for a period P2.
    Intervention Type
    Device
    Intervention Name(s)
    transillumination dispositif
    Intervention Description
    infrared light
    Primary Outcome Measure Information:
    Title
    Percentage of patients for whom peripheral venous vein placement was successful on the first attempt
    Time Frame
    immediately after procedure
    Secondary Outcome Measure Information:
    Title
    number of attempts before successful venous line placement
    Time Frame
    during the procedure
    Title
    patient pain
    Description
    The patient's pain is measured by the digital pain scale (scale ranging from 0 (no pain) to 10 (intolerable pain)).
    Time Frame
    during the procedure
    Title
    nurse stress
    Description
    Nurse stress is measured by the digital stress scale (scale ranging from 0 (no stress) to 10 (intolerable stress)).
    Time Frame
    during the procedure
    Title
    The caliber of the peripheral venous route
    Description
    measured by the type of catheter gauge used
    Time Frame
    during the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie Lecomte
    Phone
    0383155278
    Email
    ju.lecomte@chru-nancy.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Catherine Staszewski
    Email
    cathpam@hotmail.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine Staszewski
    Organizational Affiliation
    CH Pont à Mousson
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    PeRfusion Emergency VEiNlite Transillumination

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