Anyone Who Meets the Eligibility Criteria Can Use the SoftwareCOBOXNCT05528042
Validation of the Performance of the COBOX Solution for Measuring Heart Rate and Respiratory Rate
A study testing Heart rate and respiratory rate measurement in people with Anyone Who Meets the Eligibility Criteria Can Use the Software, run by Quantiq.io.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anyone Who Meets the Eligibility Criteria Can Use the Software
- What is being tested?
- Heart rate and respiratory rate measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2022to 19 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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 :
Read more
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.
Read the 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.
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.
- Being tested
- Heart rate and respiratory rate measurement
- Keywords
- Heart rate, respiratory rate, COBOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate and respiratory rate measurementOther
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
| Study group | Role | What they receive |
|---|---|---|
| N/A, only one arm | Other | 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. Receives: Other: Heart rate and respiratory rate measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: less than 30 minutes
Secondary outcomes (1)
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
Measured: less than 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start9 Sep 2022 (estimated)
- Primary completion19 Sep 2022 (estimated)
- Study completion19 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anyone Who Meets the Eligibility Criteria Can Use the SoftwareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We carry out a multicentric, prospective clinical research, evaluating the performance of the COBOX device to the extent and within the framework of usual care. Heart rate and respiratory rate are measured when a patient arrives in the emergency room, also, given the high attendance of these services, it seemed to us to be an excellent place for this study. This measurement is carried out as part of the patient's care pathway using the reference process techniques for taking measurements via a CE marked device and a manual counting reference method. The inclusions of the patient consultant in the emergencies service allow you to quickly obtain a large number of inclusions, and also, a great variability of the constants revealed by the different pathological stages. This allows a large reproduction in the combination of clinical situations and allows validating the actions in different contexts
- Masking
- None (open label)
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quantiq.io
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528042
- Sponsor's protocol ID
- 2022-A00818-35
- Acronym
- COBOX
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Performance of the COBOX Solution for Measuring Heart Rate and Respiratory Rate
- ClinicalTrials.gov ID
- NCT05528042
- Acronym / sponsor ID
- COBOX / 2022-A00818-35
- Keywords
- Heart rate, respiratory rate, COBOX
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Quantiq.ioUniversity, hospital or other
- Study start
- 9 Sep 2022 (estimated)
- Primary completion
- 19 Sep 2022 (estimated)
- Study completion
- 19 Sep 2022 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We carry out a multicentric, prospective clinical research, evaluating the performance of the COBOX device to the extent and within the framework of usual care. Heart rate and respiratory rate are measured when a patient arrives in the emergency room, also, given the high attendance of these services, it seemed to us to be an excellent place for this study. This measurement is carried out as part of the patient's care pathway using the reference process techniques for taking measurements via a CE marked device and a manual counting reference method. The inclusions of the patient consultant in the emergencies service allow you to quickly obtain a large number of inclusions, and also, a great variability of the constants revealed by the different pathological stages. This allows a large reproduction in the combination of clinical situations and allows validating the actions in different contexts
| Arm | Type | Receives |
|---|---|---|
| N/A, only one arm | Other | Other: Heart rate and respiratory rate measurementAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate and respiratory rate measurementValidation 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 | Other | N/A, only one arm |
Primary outcome
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.
1 secondary outcome
Respiratory rate
Time frame: less than 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate and respiratory rate measurement in people with Anyone Who Meets the Eligibility Criteria Can Use the Software, run by Quantiq.io.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabien Niel, PHD (06 50 89 39 29, fabien@quantiq.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: less than 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.