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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05240079
Acronym
CARDIASENS_2
Enrollment
200
Registered
2022-02-15
Start date
2022-03-15
Completion date
2023-11-15
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telemedicine

Keywords

Telemedicine, Heart rate, photoplethysmography

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.

Interventions

DEVICEHeart 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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Caducy's heart rate measurement compared to standardthrough study completion, an average of 6 monthHeart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY

Secondary

MeasureTime frameDescription
Caducy's SpO2 measurement compared to standardthrough study completion, an average of 6 monthBlood oxygen saturation (%) taken by gold standard Blood oxygen saturation (%) calculated by CADUCY

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026