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

Telemedicine Clinical Trial

— CARDIASENS_2  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05240079
• Other study ID #: 2021-A02217-34
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: November 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Telemedicine

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caducy's heart rate measurement compared to standard	Heart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY	through study completion, an average of 6 month
Secondary	Caducy's SpO2 measurement compared to standard	Blood oxygen saturation (%) taken by gold standard Blood oxygen saturation (%) calculated by CADUCY	through study completion, an average of 6 month