DiCART TM Device for Capillary Refill Time Measurement

Not Applicable

Completed

• Conditions: Peripheral Perfusion
• Interventions: Device: measure capillary refill time

• Registration Number: NCT04538612
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Primary Completion: 2020-07-10
• Study Completion: 2020-07-10
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy volunteers
• Age > 18 years old
• Informed consent to participate

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
measure capillary refill time	measure capillary refill time	-

Primary Outcome Measures

Name	Time	Method
Capillary refill time on the thenar eminence evaluated with DiCART TM device.	180 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Inter-observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.	180 minutes	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.
Capillary refill time measured by mathematical algorithms	180 minutes	After the experimental phase, the investigators will develop mathematical algorithms to optimize video data interpretation.
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with standard clinical method.	180 minutes	Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.
Pain evaluation assessed by numeric rating scale	180 minutes	Pain scale (minimum 1 to maximum 10), 1=No pain,10=Unbearable pain
Capillary refill time evaluated on the knee with DiCART TM device	180 minutes	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.
Intra -observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.	180 minutes	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.
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with DiCART TM device .	180 minutes	Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.
Intra -observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.	180 minutes	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.
Capillary refill time variation induced by vascular occlusion test on the knee with standard clinical method	180 minutes	Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.
number of patients with cutaneous lesions	180 minutes	To evaluate the safety of DiCART TM device
Inter-observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.	180 minutes	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.
Capillary refill time variation induced by vascular occlusion test on the knee with DiCART TM device	180 minutes	Standard clinical measurement is realized by applying a firm pressure with the finger during 15s and by brutally releasing it. Then, skin recoloration is evaluated visually with a chronometer.

Trial Locations

Locations (1)

Hospital Louis Pradel; 🇫🇷 Bron, France