Validation of the Performance of the COBOX Solution for Measuring Heart Rate and Respiratory Rate

Quantiq.io

Status: Not yet enrolling

Conditions: Anyone Who Meets the Eligibility Criteria Can Use the Software

Treatments: Other: Heart rate and respiratory rate measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05528042

2022-A00818-35

Details and patient eligibility

About

Quantiq.io "COBOX" is a software as a medical device. It relies on remote photoplethysmography, allowing for the remote measurement of a patient's physiological parameters from a healthcare professional's or patient's device which can be a smartphone, a computer or a health station with an optical camera.

Quantiq.io software is a medical device which is :

contactless for the measurement non-invasive for the patient

In order to meet safety and quality standards, new health technologies require rigorous clinical validation with measurement performance at least equivalent to that of one CE marking measure device.

In this context, we assume that the COBOX device will take measurements of heart and respiratory rates equivalent to those taken by medical devices and current practices.

Full description

The planned procedure is:

1. Oral information to the patient about the test by the nursing staff.
2. Patient signs the consent.
3. Collection of the patient's age, gender and Fitzpatrick phototype.
4. Collection of the patient identification number.
5. The nursing staff installs the oximeter on the patient's finger.
6. The nursing staff starts COBOX and begins to count the patient's breath in parallel
7. After 15, a first measurement is made by COBOX. The pulse oximeter reference result is acquired in parallel.
8. After 20s (5s after the previous measurement) a second measurement is made by COBOX.
9. After 25s (5 after the previous measurement) a third measurement is made by COBOX.
10. After 30s, the nursing staff enters the number of patient's breaths counted since the start.

The performance of the tool will be estimated by the concordance between the measurements obtained from the application of the reference technical process via a CE marked device and with the measurements obtained by COBOX.

An intraclass correlation coefficient (ICC) with its 95% confidence interval (95% CI) will be calculated. Measurement errors will be calculated and expressed as a percentage (root mean square error, etc.).

The two study samples will be compared by Student's t test and Fischer's F, with a desired significance for P value = 0.05, for all the analyses.

A DIXON test will be performed to assess the presence of statistically outliers within the samples.

These data will enable the COBOX tool, a class IIA medical device, to be validated in terms of measurement performance compared to a CE-marked device used in a reference technical process for taking measurements and a reference method for manual counting.

Enrollment: 323 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patient (older than 18 years old)
• Patient consulting in the emergency department of a participating center
• Patient having constant FC and FR taken by the reception organizing nurse (IOA) in the area dedicated to the reception of patients
• Patient who gave their consent to participate in the study

Exclusion criteria

• Patient in a state of vital emergency with direct entry into emergency service or intensive care
• Patient unable to express consent.
• Patient unable, for health reasons, to be face of COBOX.
• Patient unable to stay for 30 seconds facing the Cobox solution.
• Patient with skin stigma over more than 50% of the face (burn, graft)
• Patient with the face covered or not allowing access to the entire face (clothing)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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323 participants in 1 patient group

N/A, only one arm

Other group

Description:

All the patients that would like to participate and those where the inclusion criteria are past, are available to make the test. No drugs are administered.

Treatment:

Other: Heart rate and respiratory rate measurement