Validation of the Performance of the COBOX Solution for Measuring Heart Rate and Respiratory Rate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Quantiq.io
- Enrollment
- 323
- Primary Endpoint
- Heart rate
Study Overview
Brief Summary
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.
Detailed Description
The planned procedure is:
- Oral information to the patient about the test by the nursing staff.
- Patient signs the consent.
- Collection of the patient's age, gender and Fitzpatrick phototype.
- Collection of the patient identification number.
- The nursing staff installs the oximeter on the patient's finger.
- The nursing staff starts COBOX and begins to count the patient's breath in parallel
- After 15, a first measurement is made by COBOX. The pulse oximeter reference result is acquired in parallel.
- After 20s (5s after the previous measurement) a second measurement is made by COBOX.
- After 25s (5 after the previous measurement) a third measurement is made by COBOX.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
All the parties will be aware of the study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: Heart rate and respiratory rate measurement (Other)
Outcomes
Primary Outcomes
Heart rate
Time Frame: less than 30 minutes
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.
Secondary Outcomes
- Respiratory rate(less than 30 minutes)