Infrared for Peripheral Venous Catheterization in the Critically-ill

Peripheral Venous Catheterization Clinical Trial

— ICARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932214
• Other study ID #: PHRIP-18-0617
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Fabien BOUSSELY, senior officer
• Phone: 01 49 81 42 50
• Email: fabien.boussely[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Peripheral Venous Catheterization

Intervention

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

Locations

Country	Name	City	State
France	Henri-Mondor Hospital	Créteil	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af. — View Citation

Loon FHJV, Puijn LAPM, Houterman S, Bouwman ARA. Development of the A-DIVA Scale: A Clinical Predictive Scale to Identify Difficult Intravenous Access in Adult Patients Based on Clinical Observations. Medicine (Baltimore). 2016 Apr;95(16):e3428. doi: 10.1097/MD.0000000000003428. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of primary success of peripheral venous catheterization in the upper limbs.	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.	Day 1
Secondary	Number of punctures required for peripheral venous catheterization.		Day 1
Secondary	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

External Links

•   Société française d'hygiène hospitalière (SF2H). Prévention des infections liées aux cathéters veineux périphériques. [Internet]. 2005 [cited 2017 Sep 1];