Second Generation DICART Prototype Validation

Shock Clinical Trial

— DICART II  

Official title:

Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05847998
• Other study ID #: 69HCL21_0635
• Secondary ID: 2021-A02595-36
• Status: Completed
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: October 28, 2023

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 28, 2023
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Circulatory Failure
• Shock

Intervention

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.

Locations

Country	Name	City	State
France	Louis Pradel Cardiologic Hospistal	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical capillary refill time measurement.	Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.	during procedure
Primary	automatic DICART capillary refill time measurement.	Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.	during procedure
Secondary	ROC curve with DICART device	ROC curve for DICART performance to detect a tissular hypoperfusion, defined as a clinical CRT superior to 3s	during procedure
Secondary	Inter-operator reproducibility in CRT measurement with DICART device	reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis	during procedure
Secondary	Inter-operator reproducibility in CRT measurement with clinical method	reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis	during procedure
Secondary	Intra-operator reproducibility in CRT measurement with DICART device	reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis	during procedure
Secondary	Intra-operator reproducibility in CRT measurement with clinical method	reproducibility in CRT measurement with DICART device using Bland-Altman comparison analysis	during procedure
Secondary	vital status	Association between CRT and 30 day survival without renal replacement therapy	30 days
Secondary	survival rate without renal replacement therapy		30 days
Secondary	skin lesion assessed by clinical examination	Safety consideration about DICART use: qualitative skin examination	during procedure
Secondary	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)	during procedure
Secondary	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".	during procedure