Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628975
Status:
UNKNOWN
Last Update Posted:
2020-11-16
First Post:
2020-10-21
Brief Title:
PeRfusion Emergency VEiNlite Transillumination
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVENT
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None