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

Primary Purpose

Peripheral Venous Catheterization

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ACCUVEIN
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Venous Catheterization focused on measuring venous access, illumination, infrared, critically-ill, catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri-Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Infrared illumination group

Control group

Arm Description

The nurse uses the Accuvein® device to identify the veins before puncture.

The nurse proceeds as usual (visual identification in the light of the room and palpation)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of punctures required for peripheral venous catheterization.
Rate of failure of the procedure, defined by the absence of placement of a peripheral venous catheter before the end of the procedure

Full Information

First Posted
April 26, 2019
Last Updated
May 12, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03932214
Brief Title
Infrared for Peripheral Venous Catheterization in the Critically-ill
Acronym
ICARE
Official Title
Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Venous Catheterization
Keywords
venous access, illumination, infrared, critically-ill, catheterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infrared illumination group
Arm Type
Experimental
Arm Description
The nurse uses the Accuvein® device to identify the veins before puncture.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The nurse proceeds as usual (visual identification in the light of the room and palpation)
Intervention Type
Device
Intervention Name(s)
ACCUVEIN
Intervention Description
The nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device.
Primary Outcome Measure Information:
Title
Percentage of primary success of peripheral venous catheterization in the upper limbs.
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of punctures required for peripheral venous catheterization.
Time Frame
Day 1
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien BOUSSELY, senior officer
Phone
01 49 81 42 50
Ext
33
Email
fabien.boussely@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Akim SOUAG
Phone
(0)1 44 84 17 15
Ext
33
Email
akim.souag@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien BOUSSELY, senior officer
Organizational Affiliation
Assistance publique des hopitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri-Mondor Hospital
City
Créteil
State/Province
Val De Marne
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien Boussely
Email
fabien.boussely@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Citations:
PubMed Identifier
23353941
Citation
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.
Results Reference
background
PubMed Identifier
27100437
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.
Results Reference
background
Links:
URL
https://www.has-sante.fr/portail/upload/docs/application/pdf/Catheters_veineux_2005_rap.pdf
Description
Société française d'hygiène hospitalière (SF2H). Prévention des infections liées aux cathéters veineux périphériques. [Internet]. 2005 [cited 2017 Sep 1];

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Infrared for Peripheral Venous Catheterization in the Critically-ill

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