Evaluation of a New System for Heart Rate and SpO2 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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2023-11-15

Brief Summary

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Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of acquisition regardless the human variability. The Caducy system measurement via camera is made by filming the visage of the patient during 1 minute.

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Detailed Description

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Conditions

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Telemedicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients

Group Type EXPERIMENTAL

Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice).

Intervention Type DEVICE

Heart rate and SpO2 measurement with Caducy (the visage of the subject is filmed 30 seconds and 1 minute with a camera) and heart rate and SpO2 measurement with gold standard (heart rate monitor and oximeter pod linked to an acquisition station). The procedure is repeated twice.

Interventions

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Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice).

Heart rate and SpO2 measurement with Caducy (the visage of the subject is filmed 30 seconds and 1 minute with a camera) and heart rate and SpO2 measurement with gold standard (heart rate monitor and oximeter pod linked to an acquisition station). The procedure is repeated twice.

Intervention Type DEVICE

Other Intervention Names

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Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice).

Eligibility Criteria

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Inclusion Criteria

* Be 18 years of age or over.
* Patient affiliated to a social security scheme.
* Having received complete information on the organization of the research.
* Able to understand the requirements of the trial and having signed a free and informed consent prior to entering the study
* Patient taken care of by the CUMSAPA (Centre Universitaire de Médecine du Sport et Activité Physique Adaptées) service for an PFT (pulmonary function test), stress test, consultation of adapted physical activity or other functional explorations carried out by the service.
* Patient having carried out a preliminary clinical examination.

Exclusion Criteria

* Acute phenomenon contra-indicating the performance of an PFT, stress test or other functional exploration.
* Person with tremors at the time of clinical examination (Parkinson, spasms...)
* People who cannot present the palms of both hands (amputation).
* Woman of childbearing age who does not have effective contraception.
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: Pregnant woman, parturient or nursing mother, Minor (non-emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice), Person of full age unable to express consent
* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes