Second Generation DICART Prototype Validation

Hospices Civils de Lyon25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Acute Circulatory Failure Shock

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Louis Pradel Cardiologic Hospistal

Bron, France

Outcomes

Primary Outcomes

clinical capillary refill time measurement.

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

Time frame: during procedure

automatic DICART capillary refill time measurement.

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

Time frame: during procedure

Secondary Outcomes

ROC curve with DICART device

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

Time frame: during procedure

Inter-operator reproducibility in CRT measurement with DICART device

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

Time frame: during procedure

Inter-operator reproducibility in CRT measurement with clinical method

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

Time frame: during procedure

Intra-operator reproducibility in CRT measurement with DICART device

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

Time frame: during procedure

Intra-operator reproducibility in CRT measurement with clinical method

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

Time frame: during procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.