Second Generation DICART Prototype Validation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2023-10-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Circulatory Failure Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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measurement of capillary refill time

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

Group Type EXPERIMENTAL

Standardized measurement of capillary refill time by second generation DICART prototype

Intervention Type DEVICE

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 time

Intervention Type DIAGNOSTIC_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.

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No