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Clinical Trials/NCT03932214
NCT03932214
Recruiting
Not Applicable

Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients

Assistance Publique - Hôpitaux de Paris1 site in 1 country460 target enrollmentDecember 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Venous Catheterization
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
460
Locations
1
Primary Endpoint
Percentage of primary success of peripheral venous catheterization in the upper limbs.
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 19, 2019
End Date
January 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Number of punctures required for peripheral venous catheterization.(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(Day 1)

Study Sites (1)

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