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Infrared for Peripheral Venous Catheterization in the Critically-ill

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03932214
Acronym
ICARE
Enrollment
460
Registered
2019-04-30
Start date
2019-12-19
Completion date
2025-01-01
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Venous Catheterization

Keywords

venous access, illumination, infrared, critically-ill, catheterization

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.

Interventions

DEVICEACCUVEIN

The nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of primary success of peripheral venous catheterization in the upper limbs.Day 1success 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

MeasureTime frame
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 procedureDay 1

Countries

France

Contacts

Primary ContactFabien BOUSSELY, senior officer
fabien.boussely@aphp.fr01 49 81 42 50
Backup ContactAkim SOUAG
akim.souag@aphp.fr(0)1 44 84 17 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026