Infrared for Peripheral Venous Catheterization in the Critically-ill (ICARE)
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|ClinicalTrials.gov Identifier: NCT03932214|
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : October 27, 2020
Peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications.
Venous access difficulties are frequent in critically-ill patients. Among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. Infrared illumination has never been evaluated in intensive care. However, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. Our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique The objective is to evaluate the interest of infrared illumination (AccuVein AV500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult.
It is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase III trial. Subjects will be divided into two groups with a 1: 1 ratio. Nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Venous Catheterization||Device: ACCUVEIN||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Subjects will be divided into two groups with a 1: 1 ratio. Each patient will be assigned to one of the following 2 arms:
- Usual technique : Visualization of the vein to be catheterized will be done directly. without infrared illumination.
-Use of the Accuvein® device: Visualization of the vein to be catheterized will be done with infrared illumination.
In both groups, catheterization will be carried out according to the usual technique in accordance with the recommendations.
|Masking:||None (Open Label)|
|Official Title:||Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients|
|Actual Study Start Date :||December 19, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: Infrared illumination group
The nurse uses the Accuvein® device to identify the veins before puncture.
The nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device.
No Intervention: Control group
The nurse proceeds as usual (visual identification in the light of the room and palpation)
- Percentage of primary success of peripheral venous catheterization in the upper limbs. [ Time Frame: Day 1 ]
success defined as the need of a single puncture for the effective catheterization.
The effective catheterization is confirmed by obtaining venous reflux by declivity of the infusion bag.
- Number of punctures required for peripheral venous catheterization. [ Time Frame: Day 1 ]
- Rate of failure of the procedure, defined by the absence of placement of a peripheral venous catheter before the end of the procedure [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932214
|Contact: Fabien BOUSSELY, senior officer||01 49 81 42 50 ext email@example.com|
|Contact: Akim SOUAG||(0)1 44 84 17 15 ext firstname.lastname@example.org|
|Créteil, Val De Marne, France, 94000|
|Contact: Fabien Boussely email@example.com|
|Principal Investigator:||Fabien BOUSSELY, senior officer||Assistance publique des hopitaux de Paris|