NCT05847998

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2023

Completed
Last Updated

August 1, 2025

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

February 16, 2023

Last Update Submit

July 29, 2025

Conditions

Acute Circulatory FailureShock

Keywords

Acute Circulatory FailureShockcapillary refill time (CRT)prognosisdiagnosticevaluation

Outcome Measures

Primary Outcomes (2)

  • clinical capillary refill time measurement.

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

    during procedure

  • automatic DICART capillary refill time measurement.

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

    during procedure

Secondary Outcomes (10)

  • ROC curve with DICART device

    during procedure

  • Inter-operator reproducibility in CRT measurement with DICART device

    during procedure

  • Inter-operator reproducibility in CRT measurement with clinical method

    during procedure

  • Intra-operator reproducibility in CRT measurement with DICART device

    during procedure

  • Intra-operator reproducibility in CRT measurement with clinical method

    during procedure

  • +5 more secondary outcomes

Study Arms (1)

measurement of capillary refill time

EXPERIMENTAL

measurement in a cohort of ICU adult patients with acute circulatory failure

Device: Standardized measurement of capillary refill time by second generation DICART prototypeDiagnostic Test: Clinical measurement of capillary refill time

Interventions

Standardized measurement of capillary refill time by second generation DICART prototypeDEVICE

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

measurement of capillary refill time
Clinical measurement of capillary refill timeDIAGNOSTIC_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.

measurement of capillary refill time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years old
  • Acute circulatory failure
  • Written informed consent given by patient or its relatives

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Pradel Cardiologic Hospistal

Bron, France

Location

Related Publications (1)

  • Descamps A, Jacquet-Lagreze M, Aussal T, Fellahi JL, Ruste M. DiCARTTM device to measure capillary refill time: a validation study in patients with acute circulatory failure. J Clin Monit Comput. 2025 Oct;39(5):831-840. doi: 10.1007/s10877-025-01271-5. Epub 2025 Feb 26.

    PMID: 40011397RESULT

MeSH Terms

Conditions

ShockDisease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias JACQUET-LAGREZE, MD, PHD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

May 8, 2023

Study Start

April 6, 2023

Primary Completion

October 28, 2023

Study Completion

October 28, 2023

Last Updated

August 1, 2025

Record last verified: 2024-03

Locations

FR(1)