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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anyone Who Meets the Eligibility Criteria Can Use the Software
• Intervention / Treatment: Other: Heart rate and respiratory rate measurement

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 323
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabien Niel, PHD; Phone Number: 06 50 89 39 29; Email: fabien@quantiq.io
• Study Contact Backup: Name: Alain Habra, Master; Phone Number: 06 13 29 19 21; Email: alain@quantiq.io

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: N/A, only one arm; 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.

Other: Heart rate and respiratory rate measurement; Validation of the performance of the heart rate (HR) measurement using COBOX medical device compared to a measurement carried out by applying the reference processes for taking measurements via a CE marked device. Evaluation of the performance of the respiratory rate (RR) measurement using COBOX medical device compared to a measurement carried out by a reference method of manual counting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	validate the performance of the measurement of the heart rate (HR) measured by the COBOX medical device compared to a measurement carried out by applying the reference processes for taking measurements via a CE marked device.	less than 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	Evaluate the performance of the measurement of the respiratory rate (RR) measured by the COBOX medical device compared to a measurement carried out by a reference method of manual counting	less than 30 minutes

Collaborators and Investigators

• Sponsor: Quantiq.io

Study record dates

Study Major Dates

• Study Start (Anticipated): September 9, 2022
• Primary Completion (Anticipated): September 19, 2022
• Study Completion (Anticipated): September 19, 2022

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Heart rate, respiratory rate, COBOX
• Other Study ID Numbers: 2022-A00818-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The information about the test is communicated by the nurse and if necessary completed by a doctor. This information must make it possible to answer all the patient's questions concerning the objective, the nature of the constraints, the foreseeable risks and the expected benefits of the research. It also specifies the patient's rights in the context of a clinical investigation and respects the eligibility criteria. A copy of the electronic consent form is then given to the patient by the investigating doctor.
• IPD Sharing Time Frame: 09-19-2022
• IPD Sharing Access Criteria: Criteria:The consent form is electronic and must be signed before data can be provided for research. After electronic acceptance of the consent, a copy of the consent form is sent to the patient with his identification number allowing him at any time to ask the promoter to delete his data. For his part, the promoter only has access to the patient's identification number but his email address is not stored.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No