NCT04538612

DiCART TM Device for Capillary Refill Time Measurement

DiCART TM Device for Capillary Refill Time Measurement : a Validation Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To estimate peripheral perfusion in shock state, international guidelines recommend the use of capillary refill time, and practitioners currently evaluates it at bedside. However its measurement is not standardized, what should explain the large observer variability reported in different studies. Hence, a device providing a standardized evaluation seems to be helpful. The aim of the study is to evaluate diagnostic performance of such a device recently developped (DiCART TM), in healthy volunteers experiencing vascular occlusion tests to induce impaired perfusion.

Conditions

• Peripheral Perfusion

Interventions

Type	Name	Description
DEVICE	measure capillary refill time	Each time, capillary refill time will be evaluated three times consecutively by clinical method applying a firm pressure with the finger during 15s, then brutally releasing it, and estimating time of skin recoloration with a chronometer and by DiCART TM device Three vascular occlusion tests will be successively performed with a cuff during less than 10 minutes: * Arterial vascular occlusion test (50mmHg above systolic arterial pressure of the healthy volunteers), * Veinous vascular occlusion test (30mmHg), * Control test without vascular occlusion test. Capillary refill time measurements will be repeated just before, during and just after vascular occlusion tests. Randomization determine the order of the vascular occlusion tests. Investigators performing capillary refill time evaluation will be blinded from it. Vascular occlusion tests will be alternatively performed by one and the other limb. The whole protocol will be performed at the upper and then at the lower limb.

Timeline

• Start date: 2020-01-28
• Primary completion: 2020-07-10
• Completion: 2020-07-10
• First posted: 2020-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: France