DiCART TM Device for Capillary Refill Time Measurement

Hospices Civils de Lyon20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Peripheral Perfusion

Interventions

measure capillary refill timeDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers * Age \> 18 years old * Informed consent to participate Exclusion Criteria: * Vascular disease * Diabetes mellitus * Dermatosis * Cutaneous lesion on a measurement site * Anemia * Pregnancy * Cardiovascular chronic treatment * Non affiliation to a social security regime * Involvement in other interventional study

Locations (1)

Hospital Louis Pradel

Bron, France

Outcomes

Primary Outcomes

Capillary refill time on the thenar eminence evaluated with DiCART TM device.

Diagnostic performance of DiCART TM device to detect a capillary refill time variation on the thenar eminence induced by a vascular occlusion test on the arm. DiCART TM measurement is fully automatized, and may be separated in three consecutive step : * An automatized cutaneous compression * A video acquisition of cutaneous recoloration * Data interpretation The investigators will compute Receptor Operative Characteristics curves with area under the curve, and will determine best threshold and grey zone to evaluate diagnostic performance of DiCART TM device to detect impaired perfusion.

Time frame: 180 minutes

Secondary Outcomes

Capillary refill time evaluated on the knee with DiCART TM device

Diagnostic performance of DiCART TM device to detect a capillary refill time variation on the knee induced by a vascular occlusion test on the leg DiCART TM measurement is fully automatized, and may be separated in three consecutive step : * An automatized cutaneous compression * A video acquisition of cutaneous recoloration * Data interpretation The investigators will compute Receptor Operative Characteristics curves with area under the curve, and will determine best threshold and grey zone to evaluate diagnostic performance of DiCART TM device to detect impaired perfusion.

Time frame: 180 minutes

Intra -observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.

Two different investigators will realize 5 measurements of capillary refill time with DiCART TM device and standard clinical method in physiological conditions in two different sites (knee and thenar eminence). We will compute least significant change and standard deviation/mean ratio to evaluate observer variability.

Time frame: 180 minutes

Intra -observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.