Intensive Care UnitEVITRECNCT05573659
Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients
A study testing time of cutaneous recoloration and video assisted cutaneous recoloration in people with Intensive Care Unit and Mortality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Mortality, Reliability
- What is being tested?
- time of cutaneous recoloration and video assisted cutaneous recoloration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- hospitalized in ICU
- Patient or Family /relative with Inclusion Authorization
Who cannot join
- Pregnant or lactating women
- Under protection (guardianship, curators, reinforced curators)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Intensive Care Unit, Mortality, Reliability
- Being tested
- time of cutaneous recoloration, video assisted cutaneous recoloration
- Keywords
- capillary refill time, intensive care unit, mortality, reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time of cutaneous recolorationOther
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 recolorationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| video-assisted capillary refill time. | Experimental | Not described Receives: Other: video assisted cutaneous recoloration |
| visual capillary refill time. | Active comparator | Not described Receives: Other: time of cutaneous recoloration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Variation of measure of capillary refill time between both groups.
Variation of capillary refill time measure between experimentors between both groups
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start6 Oct 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573659
- Sponsor's protocol ID
- PI2022_843_0026
- Acronym
- EVITREC
- Status last verified
- Nov 2025
- First submitted
- 6 Oct 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05573659
- Acronym / sponsor ID
- EVITREC / PI2022_843_0026
- Conditions
- Intensive Care Unit, Mortality, Reliability
- Keywords
- capillary refill time, intensive care unit, mortality, reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video-assisted capillary refill time. | Experimental | Other: video assisted cutaneous recoloration |
| visual capillary refill time. | Active comparator | Other: time of cutaneous recoloration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- hospitalized in ICU
- Patient or Family /relative with Inclusion Authorization
Key exclusion criteria (2 listed)
- Pregnant or lactating women
- Under protection (guardianship, curators, reinforced curators)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| time of cutaneous recolorationIn 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. | Other | visual capillary refill time. |
| video assisted cutaneous recolorationCompression 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. | Other | video-assisted capillary refill time. |
Primary outcome
Variation of measure of capillary refill time in visual assisted capillary refill time group.
Time frame: 28 days
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.
Time frame: 28 days
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.
Time frame: 28 days
Variation of capillary refill time measure between experimentors between both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time of cutaneous recoloration and video assisted cutaneous recoloration in people with Intensive Care Unit and Mortality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of measure of capillary refill time in visual assisted capillary refill time group. (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.