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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02595-36 | Other Identifier | IDRCB |
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Capillary refill time (CRT) is a clinical sign for diagnosis of acute circulatory failure and response to treatment but is also associated with prognosis in patient with shock.
CRT is clinically evaluated by physician with a high risk of inter and intra evaluator variations, depending, for example, on measurement site, pressure applicated or visual evaluation.
The investigator hypothesizes that CRT measurement with second generation DICART prototype will be well correlated with clinical measurement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| measurement of capillary refill time | Experimental | measurement in a cohort of ICU adult patients with acute circulatory failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized measurement of capillary refill time by second generation DICART prototype | Device | Capillary refill time is measured by two independent operators, each one blinded from the other, with second generation DICART prototype. Each operator performs two series of three consecutive measurement on the finger. Then, an operator performs a train of three measurements on the knee, and the other operator on the thorax |
| Measure | Description | Time Frame |
|---|---|---|
| clinical capillary refill time measurement. | Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement. | during procedure |
| automatic DICART capillary refill time measurement. | Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement. | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| ROC curve with DICART device | ROC curve for DICART performance to detect a tissular hypoperfusion, defined as a clinical CRT superior to 3s | during procedure |
| Inter-operator reproducibility in CRT measurement with DICART device |
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Inclusion Criteria:
->18 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias JACQUET-LAGREZE, MD, PHD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Pradel Cardiologic Hospistal | Bron | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40011397 | Result | Descamps A, Jacquet-Lagreze M, Aussal T, Fellahi JL, Ruste M. DiCARTTM device to measure capillary refill time: a validation study in patients with acute circulatory failure. J Clin Monit Comput. 2025 Oct;39(5):831-840. doi: 10.1007/s10877-025-01271-5. Epub 2025 Feb 26. |
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| ID | Term |
|---|---|
| D012769 | Shock |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Clinical measurement of capillary refill time | Diagnostic Test | Capillary refill time is clinically measured by two independent operators, each one blinded from the other. Each operator performs, two series of three consecutive measurement on the second finger. Then, an operator performs a train of three measurements on the knee, and the other operator on the thorax, inverted relative to DICART measurements. |
|
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
| during procedure |
| Inter-operator reproducibility in CRT measurement with clinical method | reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis | during procedure |
| Intra-operator reproducibility in CRT measurement with DICART device | reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis | during procedure |
| Intra-operator reproducibility in CRT measurement with clinical method | reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis | during procedure |
| vital status | Association between CRT and 30 day survival without renal replacement therapy | 30 days |
| survival rate without renal replacement therapy | 30 days |
| skin lesion assessed by clinical examination | Safety consideration about DICART use: qualitative skin examination | during procedure |
| rash assessed by clinical examination | Safety consideration about DICART use: qualitative skin examination pain evaluation by numerical rating scale (0 means none and 3 severe) | during procedure |
| pain evaluation by numerical rating scale | Safety consideration about DICART use: pain evaluation by numerical rating scale 0 corresponds to "no pain" and 10 to "worst pain imaginable". | during procedure |