DiCART TM Device for Capillary Refill Time Measurement (DICART-VS)

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

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 Overview

• Status: Completed
• Conditions: Peripheral Perfusion
• Intervention / Treatment: Device: measure capillary refill time

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Hospital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: measure capillary refill time

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	180 minutes
Intra -observer variability of capillary refill time measurement with clinical method 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.	180 minutes
Inter-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.	180 minutes
Inter-observer variability of capillary refill time measurement with clinical method 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.	180 minutes
Capillary refill time variation induced by vascular occlusion test on the knee with DiCART TM device	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.	180 minutes
Capillary refill time variation induced by vascular occlusion test on the knee with standard clinical method	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.	180 minutes
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with DiCART TM device .	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.	180 minutes
Capillary refill time variation induced by vascular occlusion test on the thenar eminence with standard clinical method.	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.	180 minutes
Capillary refill time measured by mathematical algorithms	After the experimental phase, the investigators will develop mathematical algorithms to optimize video data interpretation.	180 minutes
number of patients with cutaneous lesions	To evaluate the safety of DiCART TM device	180 minutes
Pain evaluation assessed by numeric rating scale	Pain scale (minimum 1 to maximum 10), 1=No pain,10=Unbearable pain	180 minutes

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Matthias JACQUET-LAGREZE, MD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Ruste M, Cazenave L, Tardif M, Saint-Jean C, Fellahi JL, Lagreze MJ. Measurement of capillary refill time with a handheld prototype device: a comparative validation study in healthy volunteers. J Clin Monit Comput. 2022 Oct;36(5):1271-1278. doi: 10.1007/s10877-021-00757-2. Epub 2021 Sep 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: device; capillary refill time; vascular occlusion test; impaired perfusion; healthy volunteers.
• Other Study ID Numbers: 69HCL18_0217; 2019-A00094-53 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No