DiCART TM Device for Capillary Refill Time Measurement

NCT04538612 | Completed

• 2 other identifiers: 69HCL18_02172019-A00094-53
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Perfusion

Keywords

capillary refill time; vascular occlusion test; device; impaired perfusion; healthy volunteers.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Capillary refill time evaluated on the knee with DiCART TM device

  180 minutes

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

  180 minutes

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

  180 minutes

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

  180 minutes

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

  180 minutes

Study Arms (1)

measure capillary refill time

EXPERIMENTAL

Device: measure capillary refill time

Interventions

measure capillary refill time DEVICE

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.

measure capillary refill time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospital Louis Pradel

Bron, France

Location

Related Publications (1)

• 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.

  PMID: 34550528 RESULT

Study Officials

• Matthias JACQUET-LAGREZE, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the investigators evaluate capillary refill time without knowing the status of vascular occlusion test.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 4, 2020
• Study Start: January 28, 2020
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (1)