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OpenTrials
Completed

NCT Number: NCT05847998

Second Generation DICART Prototype Validation

Capillary refill time (CRT) is a clinical sign for diagnosis of acute circulatory failure and response to treatment but is also associated with prognosis in patient with shock.

CRT is clinically evaluated by physician with a high risk of inter and intra evaluator variations, depending, for example, on measurement site, pressure applicated or visual evaluation.

The investigator hypothesizes that CRT measurement with second generation DICART prototype will be well correlated with clinical measurement.

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Key information

Conditions

Acute Circulatory Failure Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Pradel Cardiologic Hospistal

Bron, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

->18 years old

  • Acute circulatory failure
  • Written informed consent given by patient or its relatives

Exclusion criteria

  • Pregnant women, breastfeeding women, childbearing age women without oral contraception
  • Cutaneous lesion at measurement site
  • Patient under legal protection
  • Patient already included in another interventional clinical trial

Treatment and study plan

Standardized measurement of capillary refill time by second generation DICART prototype

Device

Capillary refill time is measured by two independent operators, each one blinded from the other, with second generation DICART prototype.

Each operator performs two series of three consecutive measurement on the finger.

Then, an operator performs a train of three measurements on the knee, and the other operator on the thorax

Clinical measurement of capillary refill time

Diagnostic Test

Capillary refill time is clinically measured by two independent operators, each one blinded from the other.

Each operator performs, two series of three consecutive measurement on the second finger.

Then, an operator performs a train of three measurements on the knee, and the other operator on the thorax, inverted relative to DICART measurements.

Primary outcomes

  1. clinical capillary refill time measurement.

    Time frame: during procedure

    Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.

  2. automatic DICART capillary refill time measurement.

    Time frame: during procedure

    Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.

Secondary outcomes

  1. ROC curve with DICART device

    Time frame: during procedure

    ROC curve for DICART performance to detect a tissular hypoperfusion, defined as a clinical CRT superior to 3s

  2. Inter-operator reproducibility in CRT measurement with DICART device

    Time frame: during procedure

    reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis

  3. Inter-operator reproducibility in CRT measurement with clinical method

    Time frame: during procedure

    reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis

  4. Intra-operator reproducibility in CRT measurement with DICART device

    Time frame: during procedure

    reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis

  5. Intra-operator reproducibility in CRT measurement with clinical method

    Time frame: during procedure

    reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis

  6. vital status

    Time frame: 30 days

    Association between CRT and 30 day survival without renal replacement therapy

  7. survival rate without renal replacement therapy

    Time frame: 30 days

  8. skin lesion assessed by clinical examination

    Time frame: during procedure

    Safety consideration about DICART use: qualitative skin examination

  9. rash assessed by clinical examination

    Time frame: during procedure

    Safety consideration about DICART use: qualitative skin examination pain evaluation by numerical rating scale (0 means none and 3 severe)

  10. pain evaluation by numerical rating scale

    Time frame: during procedure

    Safety consideration about DICART use: pain evaluation by numerical rating scale 0 corresponds to "no pain" and 10 to "worst pain imaginable".

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure

Acronym: DICART II

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 8, 2023
Registry last updated
Aug 1, 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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