DiCART TM Device for Capillary Refill Time Measurement

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2020-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To estimate peripheral perfusion in shock state, international guidelines recommend the use of capillary refill time, and practitioners currently evaluates it at bedside. However its measurement is not standardized, what should explain the large observer variability reported in different studies. Hence, a device providing a standardized evaluation seems to be helpful.

The aim of the study is to evaluate diagnostic performance of such a device recently developped (DiCART TM), in healthy volunteers experiencing vascular occlusion tests to induce impaired perfusion.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Technological and Patient-tailored Innovations for Maximizing Effectiveness of Cardiac Arrest Resuscitation

NCT06538155

Out-Of-Hospital Cardiac Arrest Cardiac Arrest

RECRUITING

Automated Real-time Feedback on CPR Study

NCT00539539

Heart Arrest

COMPLETED PHASE2

Arterial Blood Pressure and Cardiac Arrest

NCT06443567

Cardiac Arrest

WITHDRAWN

Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1

NCT06905613

Technical Feasibility Ambulances

RECRUITING NA

Evaluation of Efficacy of the Prototype RPC (Rapid Pulse Confirmation) Device in Detecting Return of Pulsatile Flow in Patients Preparing to Separate From CPB (Cardiopulmonary Bypass)

NCT04526249

Circulatory Failure Cardiac Arrest

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Perfusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

the investigators evaluate capillary refill time without knowing the status of vascular occlusion test.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

measure capillary refill time

Group Type EXPERIMENTAL

measure capillary refill time

Intervention Type DEVICE

Each time, capillary refill time will be evaluated three times consecutively by clinical method applying a firm pressure with the finger during 15s, then brutally releasing it, and estimating time of skin recoloration with a chronometer and by DiCART TM device

Three vascular occlusion tests will be successively performed with a cuff during less than 10 minutes:

* Arterial vascular occlusion test (50mmHg above systolic arterial pressure of the healthy volunteers),
* Veinous vascular occlusion test (30mmHg),
* Control test without vascular occlusion test. Capillary refill time measurements will be repeated just before, during and just after vascular occlusion tests.

Randomization determine the order of the vascular occlusion tests. Investigators performing capillary refill time evaluation will be blinded from it. Vascular occlusion tests will be alternatively performed by one and the other limb. The whole protocol will be performed at the upper and then at the lower limb.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

measure capillary refill time

Each time, capillary refill time will be evaluated three times consecutively by clinical method applying a firm pressure with the finger during 15s, then brutally releasing it, and estimating time of skin recoloration with a chronometer and by DiCART TM device

Three vascular occlusion tests will be successively performed with a cuff during less than 10 minutes:

* Arterial vascular occlusion test (50mmHg above systolic arterial pressure of the healthy volunteers),
* Veinous vascular occlusion test (30mmHg),
* Control test without vascular occlusion test. Capillary refill time measurements will be repeated just before, during and just after vascular occlusion tests.

Randomization determine the order of the vascular occlusion tests. Investigators performing capillary refill time evaluation will be blinded from it. Vascular occlusion tests will be alternatively performed by one and the other limb. The whole protocol will be performed at the upper and then at the lower limb.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy volunteers
* Age \> 18 years old
* Informed consent to participate

Exclusion Criteria

* Vascular disease
* Diabetes mellitus
* Dermatosis
* Cutaneous lesion on a measurement site
* Anemia
* Pregnancy
* Cardiovascular chronic treatment
* Non affiliation to a social security regime
* Involvement in other interventional study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes