## Protocol Section
### Identification Module
**NCT ID:** NCT05240079

**Acronym:** CARDIASENS_2

**Brief Title:** Evaluation of a New System for Heart Rate and SpO2 Measurement.

**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

#### Organization Study ID Info
**ID:** 2021-A02217-34
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2023-11-15

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2022-02-15

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-10

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-09-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-03-15

**Type:** ESTIMATED

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2022-02-15
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-19
**Study First Submit QC Date:** 2022-02-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Telemedicine

**Keywords:**

- Telemedicine

- Heart rate

- photoplethysmography

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

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

**Label:** Patients

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients

**Description:** 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.

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

**Other Names:**

- Heart rate measurement with gold standard system (twice). SpO2 measurement with gold standard system (twice).

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Heart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY

**Measure:** Caducy's heart rate measurement compared to standard

**Time Frame:** through study completion, an average of 6 month

#### Secondary Outcomes

**Description:** Blood oxygen saturation (%) taken by gold standard Blood oxygen saturation (%) calculated by CADUCY

**Measure:** Caducy's SpO2 measurement compared to standard

**Time Frame:** through study completion, an average of 6 month

### Eligibility Module

**Eligibility 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
