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Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients (EVITREC)

Primary Purpose

Intensive Care Unit, Mortality, Reliability

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
time of cutaneous recoloration
video assisted cutaneous recoloration
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intensive Care Unit focused on measuring capillary refill time, intensive care unit, mortality, reliability

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years
  • hospitalized in ICU
  • Patient or Family /relative with Inclusion Authorization

Exclusion Criteria:

  • Pregnant or lactating women
  • Under protection (guardianship, curators, reinforced curators)

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

video-assisted capillary refill time.

visual capillary refill time.

Arm Description

Outcomes

Primary Outcome Measures

Variation of measure of capillary refill time in visual assisted capillary refill time group.
Variation of capillary refill time measure between experimentors in visual assisted capillary refill time group.
Variation of measure of capillary refill time in video assisted capillary refill time group.
Variation of capillary refill time measure between experimentors in video assisted capillary refill time group.
Variation of measure of capillary refill time between both groups.
Variation of capillary refill time measure between experimentors between both groups

Secondary Outcome Measures

Full Information

First Posted
October 6, 2022
Last Updated
August 22, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05573659
Brief Title
Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients
Acronym
EVITREC
Official Title
Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients a Prospective Monocentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

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
Capillary refill time is the time it takes for the skin to regain its initial colour after moderate pressure. It is usually performed on the patient index finger, middle finger or ring finger with the examiner's thumb and index finger for five seconds, three measurements having to be averaged. Capillary refill time has a dependent operator character, but it has been shown to be accurately correlated with 14-day mortality in septic shock, hospitalisation need in pediatric population. The purpose of this project is to show that capillary refill time obtained by a video-assisted method has a better inter- and intra-observer reproducibility than capillary refill time obtained by a visual method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit, Mortality, Reliability
Keywords
capillary refill time, intensive care unit, mortality, reliability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
video-assisted capillary refill time.
Arm Type
Experimental
Arm Title
visual capillary refill time.
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
time of cutaneous recoloration
Intervention Description
In the shortest time possible (less than 3 minutes), realization of three successive measurements of the time of cutaneous recoloration by a pressure by the so-called visual method by two intensivists trained at the CRT of the surgical resuscitation service familiar with the technique of time of cutaneous recoloration. The measurements will be carried out blindly from each other.
Intervention Type
Other
Intervention Name(s)
video assisted cutaneous recoloration
Intervention Description
Compression of the nail bed of the index of the subject studied until whitening of the pressed area, then release, the force will be equivalent to 300 g on a kitchen scale TPA 808S Techwood™ and time of compressions being of 5 seconds. Smartphone camera recording of the procedure (Iphone 7™, Apple Inc., Cupertino, CA). An assistant is in charge of timing the TRC between two "tops" given by the operator, the tops corresponding to the release of the pressure on the index so the beginning of the TRC and the total recoloration of the bleached area. This wizard records the three results in seconds with the associated tenth of a second.
Primary Outcome Measure Information:
Title
Variation of measure of capillary refill time in visual assisted capillary refill time group.
Description
Variation of capillary refill time measure between experimentors in visual assisted capillary refill time group.
Time Frame
28 days
Title
Variation of measure of capillary refill time in video assisted capillary refill time group.
Description
Variation of capillary refill time measure between experimentors in video assisted capillary refill time group.
Time Frame
28 days
Title
Variation of measure of capillary refill time between both groups.
Description
Variation of capillary refill time measure between experimentors between both groups
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years hospitalized in ICU Patient or Family /relative with Inclusion Authorization Exclusion Criteria: Pregnant or lactating women Under protection (guardianship, curators, reinforced curators)
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients

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