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

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

Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE December 19, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infrared for Peripheral Venous Catheterization in the Critically-ill
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Peripheral Venous Catheterization
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932214
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fabien BOUSSELY, senior officer Assistance publique des hopitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP