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

Mortality Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573659
• Other study ID #: PI2022_843_0026
• Status: Completed
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit
• Mortality
• Reliability

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Variation of measure of capillary refill time between both groups.	Variation of capillary refill time measure between experimentors between both groups	28 days