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Completed

NCT Number: NCT04538612

DiCART TM Device for Capillary Refill Time Measurement

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.

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Key information

Conditions

Peripheral Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Louis Pradel

Bron, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Capillary refill time evaluated on the knee with DiCART TM device

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  6. Capillary refill time variation induced by vascular occlusion test on the knee with DiCART TM device

    Time frame: 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.

  7. Capillary refill time variation induced by vascular occlusion test on the knee with standard clinical method

    Time frame: 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.

  8. Capillary refill time variation induced by vascular occlusion test on the thenar eminence with DiCART TM device .

    Time frame: 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.

  9. Capillary refill time variation induced by vascular occlusion test on the thenar eminence with standard clinical method.

    Time frame: 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.

  10. Capillary refill time measured by mathematical algorithms

    Time frame: 180 minutes

    After the experimental phase, the investigators will develop mathematical algorithms to optimize video data interpretation.

  11. number of patients with cutaneous lesions

    Time frame: 180 minutes

    To evaluate the safety of DiCART TM device

  12. Pain evaluation assessed by numeric rating scale

    Time frame: 180 minutes

    Pain scale (minimum 1 to maximum 10), 1=No pain,10=Unbearable pain

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: DICART-VS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2020
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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