NCT05573659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

October 6, 2022

Last Update Submit

November 17, 2025

Conditions

Keywords

capillary refill timeintensive care unitmortalityreliability

Outcome Measures

Primary Outcomes (3)

  • 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.

    28 days

  • 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.

    28 days

  • Variation of measure of capillary refill time between both groups.

    Variation of capillary refill time measure between experimentors between both groups

    28 days

Study Arms (2)

video-assisted capillary refill time.

EXPERIMENTAL
Other: video assisted cutaneous recoloration

visual capillary refill time.

ACTIVE COMPARATOR
Other: time of cutaneous recoloration

Interventions

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.

visual capillary refill time.

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.

video-assisted capillary refill time.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • hospitalized in ICU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

October 6, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations