Acute Circulatory Failure, Shock
Conditions
Keywords
Acute Circulatory Failure, Shock, capillary refill time (CRT), prognosis, diagnostic, evaluation
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.
Interventions
DEVICEStandardized measurement of capillary refill time by second generation DICART prototype
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
DIAGNOSTIC_TESTClinical measurement of capillary refill time
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Inter-operator reproducibility in CRT measurement with DICART device | during procedure | reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis |
| Inter-operator reproducibility in CRT measurement with clinical method | during procedure | reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis |
| Intra-operator reproducibility in CRT measurement with DICART device | 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) |
| vital status | 30 days | Association between CRT and 30 day survival without renal replacement therapy |
| survival rate without renal replacement therapy | 30 days | — |
| skin lesion assessed by clinical examination | during procedure | Safety consideration about DICART use: qualitative skin examination |
| Intra-operator reproducibility in CRT measurement with clinical method | during procedure | reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis |
| 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. |
Countries
France
Outcome results
None listed