An interventional study of Standardized measurement of capillary refill time by second generation DICART prototype and Clinical measurement of capillary refill time in Acute Circulatory Failure and Shock, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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.
916 studies on the registry are indexed under Shock; 176 are open to participants now.
This study's enrollment of 25 is below the median of 77 across 540 interventional studies indexed under Shock.
Browse Shock studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
->18 years old
Exclusion Criteria:
measurement in a cohort of ICU adult patients with acute circulatory failure
Device: Standardized measurement of capillary refill time by second generation DICART prototype · Diagnostic Test: Clinical measurement of capillary refill time
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
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.
clinical capillary refill time measurement.
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
Time frame: during procedure
automatic DICART capillary refill time measurement.
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
Time frame: during procedure
ROC curve with DICART device
ROC curve for DICART performance to detect a tissular hypoperfusion, defined as a clinical CRT superior to 3s
Time frame: during procedure
Inter-operator reproducibility in CRT measurement with DICART device
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time frame: during procedure
Inter-operator reproducibility in CRT measurement with clinical method
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time frame: during procedure
Intra-operator reproducibility in CRT measurement with DICART device
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time frame: during procedure
Intra-operator reproducibility in CRT measurement with clinical method
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time frame: during procedure
vital status
Association between CRT and 30 day survival without renal replacement therapy
Time frame: 30 days
survival rate without renal replacement therapy
Time frame: 30 days
skin lesion assessed by clinical examination
Safety consideration about DICART use: qualitative skin examination
Time frame: 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)
Time frame: 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".
Time frame: during procedure
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon