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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
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.

or

-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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Infrared illumination group
The nurse uses the Accuvein® device to identify the veins before puncture.
Device: ACCUVEIN
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)



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Number of punctures required for peripheral venous catheterization. [ Time Frame: Day 1 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years; Hospitalization in intensive care;
  • Need for a peripheral venous catheter;
  • Risk of difficult peripheral venous catheterization. In practice, this risk will be considered present if it is impossible to palpate and / or visualize the upper end of the target vein and / or if the estimated vein diameter is smaller than 2mm. This definition is derived from the A-DIVA score (Loon FAJ van et al3).
  • Affiliation to the social security

Exclusion Criteria:

  • Patient who has already been enrolled in the ICARE study during the current hospitalization;
  • Refusal of patient's participation

Information from the National Library of Medicine

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


Contacts
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Contact: Fabien BOUSSELY, senior officer 01 49 81 42 50 ext 33 fabien.boussely@aphp.fr
Contact: Akim SOUAG (0)1 44 84 17 15 ext 33 akim.souag@aphp.fr

Locations
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France
Henri-Mondor Hospital Recruiting
Créteil, Val De Marne, France, 94000
Contact: Fabien Boussely       fabien.boussely@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Fabien BOUSSELY, senior officer Assistance publique des hopitaux de Paris
Additional Information:
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03932214    
Other Study ID Numbers: PHRIP-18-0617
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
venous access
illumination, infrared
critically-ill
catheterization
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes