Peripheral PerfusionDICART-VSNCT04538612
DiCART TM Device for Capillary Refill Time Measurement
A study testing measure capillary refill time in people with Peripheral Perfusion, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
To estimate peripheral perfusion in shock state, international guidelines recommend the use of capillary refill time, and practitioners currently evaluates it at bedside. However its measurement is not standardized, what should explain the large observer variability reported in different studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Perfusion
- What is being tested?
- measure capillary refill time
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2020to 10 Jul 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age > 18 years old
- Informed consent to participate
Who cannot join
- Vascular disease
- Diabetes mellitus
- Dermatosis
- Cutaneous lesion on a measurement site
- Anemia
- Pregnancy
Show all 9Show fewer
- Cardiovascular chronic treatment
- Non affiliation to a social security regime
- Involvement in other interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiCART TM Device for Capillary Refill Time Measurement : a Validation Study.
To estimate peripheral perfusion in shock state, international guidelines recommend the use of capillary refill time, and practitioners currently evaluates it at bedside. However its measurement is not standardized, what should explain the large observer variability reported in different studies. Hence, a device providing a standardized evaluation seems to be helpful.
The aim of the study is to evaluate diagnostic performance of such a device recently developped (DiCART TM), in healthy volunteers experiencing vascular occlusion tests to induce impaired perfusion.
- Conditions
- Peripheral Perfusion
- Being tested
- measure capillary refill time
- Keywords
- capillary refill time, vascular occlusion test, device, impaired perfusion, healthy volunteers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure capillary refill timeDevice
Each time, capillary refill time will be evaluated three times consecutively by clinical method applying a firm pressure with the finger during 15s, then brutally releasing it, and estimating time of skin recoloration with a chronometer and by DiCART TM device
Three vascular occlusion tests will be successively performed with a cuff during less than 10 minutes:
- Arterial vascular occlusion test (50mmHg above systolic arterial pressure of the healthy volunteers),
- Veinous vascular occlusion test (30mmHg),
- Control test without vascular occlusion test. Capillary refill time measurements will be repeated just before, during and just after vascular occlusion tests.
Randomization determine the order of the vascular occlusion tests. Investigators performing capillary refill time evaluation will be blinded from it. Vascular occlusion tests will be alternatively performed by one and the other limb. The whole protocol will be performed at the upper and then at the lower limb.
| Study group | Role | What they receive |
|---|---|---|
| measure capillary refill time | Experimental | Not described Receives: Device: measure capillary refill time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary refill time on the thenar eminence evaluated with DiCART TM device.
Diagnostic performance of DiCART TM device to detect a capillary refill time variation on the thenar eminence induced by a vascular occlusion test on the arm.
DiCART TM measurement is fully automatized, and may be separated in three consecutive step :
- An automatized cutaneous compression
- A video acquisition of cutaneous recoloration
- Data interpretation The investigators will compute Receptor Operative Characteristics curves with area under the curve, and will determine best threshold and grey zone to evaluate diagnostic performance of DiCART TM device to detect impaired perfusion.
Measured: 180 minutes
Secondary outcomes (12)
Capillary refill time evaluated on the knee with DiCART TM device
Diagnostic performance of DiCART TM device to detect a capillary refill time variation on the knee induced by a vascular occlusion test on the leg
DiCART TM measurement is fully automatized, and may be separated in three consecutive step :
- An automatized cutaneous compression
- A video acquisition of cutaneous recoloration
- Data interpretation The investigators will compute Receptor Operative Characteristics curves with area under the curve, and will determine best threshold and grey zone to evaluate diagnostic performance of DiCART TM device to detect impaired perfusion.
Measured: 180 minutes
Intra -observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.
Two different investigators will realize 5 measurements of capillary refill time with DiCART TM device and standard clinical method in physiological conditions in two different sites (knee and thenar eminence). We will compute least significant change and standard deviation/mean ratio to evaluate observer variability.
Measured: 180 minutes
Intra -observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.
Two different investigators will realize 5 measurements of capillary refill time with DiCART TM device and standard clinical method in physiological conditions in two different sites (knee and thenar eminence). We will compute least significant change and standard deviation/mean ratio to evaluate observer variability.
Measured: 180 minutes
Inter-observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.
Two different investigators will realize 5 measurements of capillary refill time with DiCART TM device and standard clinical method in physiological conditions in two different sites (knee and thenar eminence). We will compute least significant change and standard deviation/mean ratio to evaluate observer variability.
Measured: 180 minutes
Inter-observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.
Two different investigators will realize 5 measurements of capillary refill time with DiCART TM device and standard clinical method in physiological conditions in two different sites (knee and thenar eminence). We will compute least significant change and standard deviation/mean ratio to evaluate observer variability.
Measured: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the knee with DiCART TM device
Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.
Measured: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the knee with standard clinical method
Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.
Measured: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with DiCART TM device .
Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.
Measured: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with standard clinical method.
Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.
Measured: 180 minutes
Capillary refill time measured by mathematical algorithms
After the experimental phase, the investigators will develop mathematical algorithms to optimize video data interpretation.
Measured: 180 minutes
number of patients with cutaneous lesions
To evaluate the safety of DiCART TM device
Measured: 180 minutes
Pain evaluation assessed by numeric rating scale
Pain scale (minimum 1 to maximum 10), 1=No pain,10=Unbearable pain
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start28 Jan 2020
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral PerfusionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias JACQUET-LAGREZE, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538612
- Sponsor's protocol ID
- 69HCL18_0217
- Other IDs
- 2019-A00094-53
- Acronym
- DICART-VS
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ruste M, Cazenave L, Tardif M, Saint-Jean C, Fellahi JL, Lagreze MJ. Measurement of capillary refill time with a handheld prototype device: a comparative validation study in healthy volunteers. J Clin Monit Comput. 2022 Oct;36(5):1271-1278. doi: 10.1007/s10877-021-00757-2. Epub 2021 Sep 22.
PubMed 34550528
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiCART TM Device for Capillary Refill Time Measurement : a Validation Study.
- ClinicalTrials.gov ID
- NCT04538612
- Acronym / sponsor ID
- DICART-VS / 69HCL18_0217
- Conditions
- Peripheral Perfusion
- Keywords
- capillary refill time, vascular occlusion test, device, impaired perfusion, healthy volunteers.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 4 Sep 2020 (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.
To estimate peripheral perfusion in shock state, international guidelines recommend the use of capillary refill time, and practitioners currently evaluates it at bedside. However its measurement is not standardized, what should explain the large observer variability reported in different studies. Hence, a device providing a standardized evaluation seems to be helpful.
The aim of the study is to evaluate diagnostic performance of such a device recently developped (DiCART TM), in healthy volunteers experiencing vascular occlusion tests to induce impaired perfusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measure capillary refill time | Experimental | Device: measure capillary refill time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Age > 18 years old
- Informed consent to participate
Key exclusion criteria (9 listed)
- Vascular disease
- Diabetes mellitus
- Dermatosis
- Cutaneous lesion on a measurement site
- Anemia
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 |
|---|---|---|
| measure capillary refill timeEach time, capillary refill time will be evaluated three times consecutively by clinical method applying a firm pressure with the finger during 15s, then brutally releasing it, and estimating time of skin recoloration with a chronometer and by DiCART TM device Three vascular occlusion tests will be successively performed with a cuff during less than 10 minutes: * Arterial vascular occlusion test (50mmHg above systolic arterial pressure of the healthy volunteers), * Veinous vascular occlusion test (30mmHg), * Control test without vascular occlusion test. Capillary refill time measurements will be repeated just before, during and just after vascular occlusion tests. Randomization determine the order of the vascular occlusion tests. Investigators performing capillary refill time evaluation will be blinded from it. Vascular occlusion tests will be alternatively performed by one and the other limb. The whole protocol will be performed at the upper and then at the lower limb. | Device | measure capillary refill time |
Primary outcome
Capillary refill time on the thenar eminence evaluated with DiCART TM device.
Time frame: 180 minutes
Diagnostic performance of DiCART TM device to detect a capillary refill time variation on the thenar eminence induced by a vascular occlusion test on the arm. DiCART TM measurement is fully automatized, and may be separated in three consecutive step : * An automatized cutaneous compression * A video acquisition of cutaneous recoloration * Data interpretation The investigators will compute Receptor Operative Characteristics curves with area under the curve, and will determine best threshold and grey zone to evaluate diagnostic performance of DiCART TM device to detect impaired perfusion.
12 secondary outcomes
Capillary refill time evaluated on the knee with DiCART TM device
Time frame: 180 minutes
Intra -observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.
Time frame: 180 minutes
Intra -observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.
Time frame: 180 minutes
Inter-observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.
Time frame: 180 minutes
Inter-observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.
Time frame: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the knee with DiCART TM device
Time frame: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the knee with standard clinical method
Time frame: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with DiCART TM device .
Time frame: 180 minutes
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with standard clinical method.
Time frame: 180 minutes
Capillary refill time measured by mathematical algorithms
Time frame: 180 minutes
number of patients with cutaneous lesions
Time frame: 180 minutes
Pain evaluation assessed by numeric rating scale
Time frame: 180 minutes
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 4 Sep 2025.
- Results publication: PubMed 34550528Ruste M, Cazenave L, Tardif M, Saint-Jean C, Fellahi JL, Lagreze MJ. Measurement of capillary refill time with a handheld prototype device: a comparative validation study in healthy volunteers. J Clin Monit Comput. 2022 Oct;36(5):1271-1278. doi: 10.1007/s10877-021-00757-2. Epub 2021 Sep 22.
- Individual participant dataSharing planned: Undecided
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Perfusion Efficiency-Guided MAP De-escalation in Elderly Septic Shock
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RecruitingObservational study
Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
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Not yet recruitingObservational study
Core-to-Big-Toe Temperature Gradient as a Marker of Peripheral Perfusion in Adult Patients With Septic Shock
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Not yet recruitingPhase 4
Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
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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.
Matthias JACQUET-LAGREZE, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measure capillary refill time in people with Peripheral Perfusion, run by Hospices Civils de Lyon 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 9 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 4 Sep 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?
Capillary refill time on the thenar eminence evaluated with DiCART TM device. (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538612, which also lists 1 linked publication.
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 4 Sep 2025.