NCT05847998

Second Generation DICART Prototype Validation

Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Circulatory Failure
• Shock

Interventions

Type	Name	Description
DEVICE	Standardized 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_TEST	Clinical 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.

Timeline

• Start date: 2023-04-06
• Primary completion: 2023-10-28
• Completion: 2023-10-28
• First posted: 2023-05-08
• Last updated: 2025-08-01

Locations

1 site across 1 country: France