Infrared for Peripheral Venous Catheterization in the Critically-ill (ICARE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Venous Catheterization
• Intervention / Treatment: Device: ACCUVEIN

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabien BOUSSELY, senior officer; Phone Number: 33 01 49 81 42 50; Email: fabien.boussely@aphp.fr
• Study Contact Backup: Name: Akim SOUAG; Phone Number: 33 (0)1 44 84 17 15; Email: akim.souag@aphp.fr

Study Locations

• France
  • Val De Marne
    • Créteil, Val De Marne, France, 94000
      • Recruiting
      • Henri-Mondor Hospital
      • Contact: Fabien Boussely; Email: fabien.boussely@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time 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 procedure	Day 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Fabien BOUSSELY, senior officer, Assistance publique des Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: critically-ill; catheterization; venous access; illumination, infrared
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: PHRIP-18-0617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No