Second Generation DICART Prototype Validation
- Conditions
- ShockAcute Circulatory Failure
- Interventions
- Device: Standardized measurement of capillary refill time by second generation DICART prototypeDiagnostic Test: Clinical measurement of capillary refill time
- Registration Number
- NCT05847998
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
->18 years old
- Acute circulatory failure
- Written informed consent given by patient or its relatives
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description measurement of capillary refill time Standardized measurement of capillary refill time by second generation DICART prototype measurement in a cohort of ICU adult patients with acute circulatory failure measurement of capillary refill time Clinical measurement of capillary refill time measurement in a cohort of ICU adult patients with acute circulatory failure
- Primary Outcome Measures
Name Time Method clinical capillary refill time measurement. during procedure Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
automatic DICART capillary refill time measurement. during procedure Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
- Secondary Outcome Measures
Name Time Method ROC curve with DICART device during procedure ROC curve for DICART performance to detect a tissular hypoperfusion, defined as a clinical CRT superior to 3s
skin lesion assessed by clinical examination during procedure Safety consideration about DICART use: qualitative skin examination
Inter-operator reproducibility in CRT measurement with DICART device during procedure reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
survival rate without renal replacement therapy 30 days pain evaluation by numerical rating scale during procedure Safety consideration about DICART use: pain evaluation by numerical rating scale 0 corresponds to "no pain" and 10 to "worst pain imaginable".
Inter-operator reproducibility in CRT measurement with clinical method during procedure reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
vital status 30 days Association between CRT and 30 day survival without renal replacement therapy
Intra-operator reproducibility in CRT measurement with DICART device during procedure reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Intra-operator reproducibility in CRT measurement with clinical method during procedure reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
rash assessed by clinical examination during procedure Safety consideration about DICART use: qualitative skin examination pain evaluation by numerical rating scale (0 means none and 3 severe)
Trial Locations
- Locations (1)
Louis Pradel Cardiologic Hospistal
🇫🇷Bron, France