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

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ClinicalTrials.gov Identifier: NCT05240079
Recruitment Status : Unknown
Verified November 2021 by Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2022
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Telemedicine Device: Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Estimated Study Start Date : March 15, 2022
Estimated Primary Completion Date : September 15, 2023
Estimated Study Completion Date : November 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arms and Interventions
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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 Name: Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice).


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT05240079    
Other Study ID Numbers: 2021-A02217-34
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Telemedicine
Heart rate
photoplethysmography