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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05573659
Collaborator
(none)
51
1
2
36.9
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: time of cutaneous recoloration
  • Other: video assisted cutaneous recoloration
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Oct 6, 2022
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: video-assisted capillary refill time.

Other: video assisted cutaneous recoloration
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.

Active Comparator: visual capillary refill time.

Other: time of cutaneous recoloration
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.

Outcome Measures

Primary Outcome Measures

  1. Variation of measure of capillary refill time in visual assisted capillary refill time group. [28 days]

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

  2. Variation of measure of capillary refill time in video assisted capillary refill time group. [28 days]

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

  3. Variation of measure of capillary refill time between both groups. [28 days]

    Variation of capillary refill time measure between experimentors between both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05573659
Other Study ID Numbers:
  • PI2022_843_0026
First Posted:
Oct 10, 2022
Last Update Posted:
Oct 10, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2022