Second Generation DICART Prototype Validation (DICART II)
Primary Purpose
Acute Circulatory Failure, Shock
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standardized measurement of capillary refill time by second generation DICART prototype
Clinical measurement of capillary refill time
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Circulatory Failure focused on measuring Acute Circulatory Failure, Shock, capillary refill time (CRT), prognosis, diagnostic, evaluation
Eligibility Criteria
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
Sites / Locations
- Louis Pradel Cardiologic HospistalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
measurement of capillary refill time
Arm Description
measurement in a cohort of ICU adult patients with acute circulatory failure
Outcomes
Primary Outcome Measures
clinical capillary refill time measurement.
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
automatic DICART capillary refill time measurement.
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
Secondary Outcome Measures
ROC curve with DICART device
ROC curve for DICART performance to detect a tissular hypoperfusion, defined as a clinical CRT superior to 3s
Inter-operator reproducibility in CRT measurement with DICART device
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Inter-operator reproducibility in CRT measurement with clinical method
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Intra-operator reproducibility in CRT measurement with DICART device
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Intra-operator reproducibility in CRT measurement with clinical method
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
vital status
Association between CRT and 30 day survival without renal replacement therapy
survival rate without renal replacement therapy
skin lesion assessed by clinical examination
Safety consideration about DICART use: qualitative skin examination
rash assessed by clinical examination
Safety consideration about DICART use: qualitative skin examination pain evaluation by numerical rating scale (0 means none and 3 severe)
pain evaluation by numerical rating scale
Safety consideration about DICART use: pain evaluation by numerical rating scale 0 corresponds to "no pain" and 10 to "worst pain imaginable".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05847998
Brief Title
Second Generation DICART Prototype Validation
Acronym
DICART II
Official Title
Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Circulatory Failure, Shock
Keywords
Acute Circulatory Failure, Shock, capillary refill time (CRT), prognosis, diagnostic, evaluation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
measurement of capillary refill time
Arm Type
Experimental
Arm Description
measurement in a cohort of ICU adult patients with acute circulatory failure
Intervention Type
Device
Intervention Name(s)
Standardized measurement of capillary refill time by second generation DICART prototype
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinical measurement of capillary refill time
Intervention Description
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 Outcome Measure Information:
Title
clinical capillary refill time measurement.
Description
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
Time Frame
during procedure
Title
automatic DICART capillary refill time measurement.
Description
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
ROC curve with DICART device
Description
ROC curve for DICART performance to detect a tissular hypoperfusion, defined as a clinical CRT superior to 3s
Time Frame
during procedure
Title
Inter-operator reproducibility in CRT measurement with DICART device
Description
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time Frame
during procedure
Title
Inter-operator reproducibility in CRT measurement with clinical method
Description
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time Frame
during procedure
Title
Intra-operator reproducibility in CRT measurement with DICART device
Description
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time Frame
during procedure
Title
Intra-operator reproducibility in CRT measurement with clinical method
Description
reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis
Time Frame
during procedure
Title
vital status
Description
Association between CRT and 30 day survival without renal replacement therapy
Time Frame
30 days
Title
survival rate without renal replacement therapy
Time Frame
30 days
Title
skin lesion assessed by clinical examination
Description
Safety consideration about DICART use: qualitative skin examination
Time Frame
during procedure
Title
rash assessed by clinical examination
Description
Safety consideration about DICART use: qualitative skin examination pain evaluation by numerical rating scale (0 means none and 3 severe)
Time Frame
during procedure
Title
pain evaluation by numerical rating scale
Description
Safety consideration about DICART use: pain evaluation by numerical rating scale 0 corresponds to "no pain" and 10 to "worst pain imaginable".
Time Frame
during procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias JACQUET-LAGREZE, MD, PHD
Phone
4 72 35 79 41
Ext
+33
Email
matthias.jacquet-Lagreze@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
JACQUET-LAGREZE
Phone
4 72 35 79 41
Ext
+33
Email
matthias.jacquet-Lagreze@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias JACQUET-LAGREZE, MD, PHD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Pradel Cardiologic Hospistal
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias JACQUET-LAGREZE
Email
matthias.jacquet-Lagreze@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Matthias JACQUET-LAGREZE
12. IPD Sharing Statement
Learn more about this trial
Second Generation DICART Prototype Validation
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