Evaluation of a New System for Heart Rate and SpO2 Measurement. (CARDIASENS_2)

February 10, 2022 updated by: Central Hospital, Nancy, France

Evaluation of Concordance Between the Measurements Obtained by an Acquisition System of Physiological Parameters (Heart Rate/SpO2) Via a Teleconsultation Camera System With Reference to Standard Acquisition Measurements

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Device: 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.
Other Names:
  • Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caducy's heart rate measurement compared to standard
Time Frame: through study completion, an average of 6 month
Heart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY
through study completion, an average of 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caducy's SpO2 measurement compared to standard
Time Frame: through study completion, an average of 6 month
Blood oxygen saturation (%) taken by gold standard Blood oxygen saturation (%) calculated by CADUCY
through study completion, an average of 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2022

Primary Completion (Anticipated)

September 15, 2023

Study Completion (Anticipated)

November 15, 2023

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-A02217-34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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