Second Generation DICART Prototype Validation

Study Overview
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Brief Summary
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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.

Official Title
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Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure

Conditions
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Acute Circulatory Failure, Shock

Intervention / Treatment
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* Device: Standardized measurement of capillary refill time by second generation DICART prototype
* Diagnostic Test: Clinical measurement of capillary refill time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ->18 years old Acute circulatory failure Written informed consent given by patient or its relatives Exclusion Criteria: Pregnant women, breastfeeding women, childbearing age women without oral contraception Cutaneous lesion at measurement site Patient under legal protection Patient already included in another interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: measurement of capillary refill time<br>measurement in a cohort of ICU adult patients with acute circulatory failure | Device: Standardized measurement of capillary refill time by second generation DICART prototype<br>* 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<br>Diagnostic Test: Clinical measurement of capillary refill time<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Circulatory Failure, Shock, capillary refill time (CRT), prognosis, diagnostic, evaluation