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
About this trial
This is an interventional other trial for Emergencies focused on measuring adult, peripheral venous approach, emergency, transillumation
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
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
NCT ID
NCT04628975
First Posted
October 21, 2020
Last Updated
November 9, 2020
Sponsor
Central Hospital, Nancy, France
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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