Second Generation DICART Prototype Validation (DICART II)

July 29, 2025 updated by: Hospices Civils de Lyon

Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Louis Pradel Cardiologic Hospistal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: measurement of capillary refill time
measurement in a cohort of ICU adult patients with acute circulatory failure
Device: Standardized measurement of capillary refill time by second generation DICART prototype

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

Diagnostic test: Clinical measurement of capillary refill time

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical capillary refill time measurement.
Time Frame: during procedure
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
during procedure
automatic DICART capillary refill time measurement.
Time Frame: during procedure
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during procedure
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
during procedure
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
during procedure
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
during procedure
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
during procedure
vital status
Time Frame: 30 days
Association between CRT and 30 day survival without renal replacement therapy
30 days
survival rate without renal replacement therapy
Time Frame: 30 days
30 days
skin lesion assessed by clinical examination
Time Frame: during procedure
Safety consideration about DICART use: qualitative skin examination
during procedure
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)
during procedure
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".
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2023

Primary Completion (Actual)

October 28, 2023

Study Completion (Actual)

October 28, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0635
  • 2021-A02595-36 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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