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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Infrared for Peripheral Venous Catheterization in the Critically-ill

Clinicaltrials.gov identifier NCT03932214

Recruitment Status Not yet recruiting

First Posted April 30, 2019

Last update posted December 17, 2019

Study Description

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:Peripheral Venous Catheterization
  • Intervention/Treatment: Device: ACCUVEIN
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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
  • Estimated Study Start Date: December 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
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.
Outcome Measures
  • 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 ]
Eligibility Criteria
  • 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

Contacts and Locations
Contacts

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
Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Fabien BOUSSELY, senior officer Assistance publique des hopitaux de Paris

More Information