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

• ClinicalTrials.gov Identifier: NCT03932214
• Recruitment Status: Recruiting
• First Posted: April 30, 2019
• Last Update Posted: October 27, 2020
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: April 26, 2019
• First Posted Date: April 30, 2019
• Last Update Posted Date: October 27, 2020
• Actual Study Start Date: December 19, 2019
• Estimated Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 26, 2019)

• Number of punctures required for peripheral venous catheterization. [ Time Frame: 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 [ Time Frame: Day 1 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Infrared for Peripheral Venous Catheterization in the Critically-ill
• Official Title: Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: 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.

Study Arms

• Experimental: Infrared illumination group
  The nurse uses the Accuvein® device to identify the veins before puncture.
  Intervention: Device: ACCUVEIN
• No Intervention: Control group
  The nurse proceeds as usual (visual identification in the light of the room and palpation)

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 26, 2019): 460
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2022
• Estimated Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03932214
• Other Study ID Numbers: PHRIP-18-0617
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

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

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: October 2020