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

NCT05240079 | Unknown

• 1 other identifier: 2021-A02217-34
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Telemedicine

Keywords

Telemedicine; Heart rate; photoplethysmography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Caducy's SpO2 measurement compared to standard

  through study completion, an average of 6 month

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

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

Also known as: Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice).

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Interventions

Heart Rate

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 15, 2022
• Study Start: March 15, 2022
• Primary Completion: September 15, 2023
• Study Completion: November 15, 2023
• Last Updated: February 15, 2022

Record last verified: 2021-11