CoronavirusNCT04489407
Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.
A study testing Remote Photoplethysmography (rPPG) vital sign acquisition in people with Coronavirus and Cardiac Disease, run by Lady Davis Institute.
Trial summary
Contactless and widely available health monitoring technologies are of growing interest in the context of the worldwide COVID-19 pandemic. Remote photoplethysmography (rPPG) is a well-studied technology that interprets variations in skin colour related to blood flow which, when analysed with complex mathematical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Cardiac Disease, Respiratory Disease
- What is being tested?
- Remote Photoplethysmography (rPPG) vital sign acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 30 Nov 2020
- 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
- Persons willing to participate and capable of providing informed consent, age of 18 years of more.
- Person able to sit still for the duration of the reading (maximum 2 minutes per reading).
- Persons with freckles, discreet skin pigmentation changes
Who cannot join
- Unable to provide informed consent
- Persons who are unable to follow basic instructions due to altered mental status, delirium, dementia or other conditions.
- Age < 18
- Intubated patients and patients requiring masks for supplemental oxygen
- Persons refusing to remove masks, eyewear, or clothing obstructing the face for the duration of readings.
- Persons with facial tattoos, large birthmarks or other skin alterations (scars, hemangiomas) on their nose or upper cheeks (cheekbones).
Trial locations and contacts
No sites are listed yet.
About this study
Contactless and widely available health monitoring technologies are of growing interest in the context of the worldwide COVID-19 pandemic. Remote photoplethysmography (rPPG) is a well-studied technology that interprets variations in skin colour related to blood flow which, when analysed with complex mathematical algorithm, generates vital sign readings. This technology has been refined and embedded in a smartphone app designed to acquire heart rate, respiratory rate and oxygen saturation using a front-facing smartphone camera.
Preliminary data comparing the accuracy of smartphone rPPG readings with conventional vital sign monitor readings are promising; however, less than 5% of the population studied in the app development phase had oxygen saturation levels below 95% making it impossible to ensure reliability in these populations.
Read more
The goal of this study is to compare readings acquired using this rPPG app with the readings from hospital grade, Health Canada approved vital signs monitors used in healthcare settings with a focus on subject with low oxygen saturations. We will also study other sociodemographic and clinical features that may influence the accuracy of the readings. This will be achieved by recruiting consenting adults presenting to care in acute care settings and a designated COVID outpatient clinic. Vital signs will be acquired using the rPPG app and conventional hospital vital sign monitors simultaneously. Readings will be repeated within 2-5 minutes when time permits. Statistical analysis will be performed to analyze the findings and determine the accuracy and precision of the rPPG app readings.
It is expected that the vital sign readings acquired with the rPPG app will be almost identical to those acquired using hospital-grade monitors for all subjects regardless of age, gender, skin colour, COVID status and relevant comorbidities.
- Conditions
- Coronavirus, Cardiac Disease, Respiratory Disease, Vascular Diseases
- Being tested
- Remote Photoplethysmography (rPPG) vital sign acquisition
- Keywords
- oximetry, pulse oximetry, respiratory rate, remote photoplethysmography, coronavirus
- Medical subject headings
- Coronavirus Infections, Heart Diseases, Respiration Disorders, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Photoplethysmography (rPPG) vital sign acquisitionDevice
Also called Welch Allyn Connex Vital Signs Monitor 6000 Series, Welch Allyn Vital Signs Monitor 7000 Series, Masimo Radical 7, Welch Allyn Vital Signs Monitor 6000 Series with Masimo rainbow SET Radical-7R pulse oximeter
Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.
| Study group | Role | What they receive |
|---|---|---|
| rPPG Vital Sign Monitor Readings | Experimental | Oxygen saturation, heart rate and respiratory rate obtained with the rPPG app. Receives: Device: Remote Photoplethysmography (rPPG) vital sign acquisition |
| Conventional Vital Sign Monitor Readings | Other | Oxygen saturation, heart rate and respiratory rate obtained with conventional vital sign monitors and manual respiratory rate counts. Receives: Device: Remote Photoplethysmography (rPPG) vital sign acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of rPPG heart rate
Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.
Measured: immediate; paired reading
Accuracy of rPPG oxygen saturation
Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.
Measured: immediate; paired reading
Accuracy of rPPG respiratory rate
Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.
Measured: immediate; paired reading
Secondary outcomes (3)
Reproducibility of rPPG heart rate readings
Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.
Measured: 2-5 minutes
Reproducibility of rPPG oxygen saturation readings
Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.
Measured: 2-5 minutes
Reproducibility of rPPG respiratory rate readings
Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.
Measured: 2-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects enrolled in the study will be undergoing vital sign monitoring with the rPPG vital sign monitoring app and the conventional vital sign monitor. Readings with each vital sign monitoring technology will be taken simultaneously on all enrolled subjects.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Carebook Technologies Inc.
- Responsible party
- Principal investigator, Noura Hassan, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489407
- Sponsor's protocol ID
- 2021-2376
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.
- ClinicalTrials.gov ID
- NCT04489407
- Acronym / sponsor ID
- 2021-2376
- Conditions
- Coronavirus, Cardiac Disease, Respiratory Disease, Vascular Diseases
- Keywords
- oximetry, pulse oximetry, respiratory rate, remote photoplethysmography, coronavirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Carebook Technologies Inc.
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 28 Jul 2020 (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.
Contactless and widely available health monitoring technologies are of growing interest in the context of the worldwide COVID-19 pandemic. Remote photoplethysmography (rPPG) is a well-studied technology that interprets variations in skin colour related to blood flow which, when analysed with complex mathematical algorithm, generates vital sign readings. This technology has been refined and embedded in a smartphone app designed to acquire heart rate, respiratory rate and oxygen saturation using a front-facing smartphone camera.
Preliminary data comparing the accuracy of smartphone rPPG readings with conventional vital sign monitor readings are promising; however, less than 5% of the population studied in the app development phase had oxygen saturation levels below 95% making it impossible to ensure reliability in these populations.
The goal of this study is to compare readings acquired using this rPPG app with the readings from hospital grade, Health Canada approved vital signs monitors used in healthcare settings with a focus on subject with low oxygen saturations. We will also study other sociodemographic and clinical features that may influence the accuracy of the readings. This will be achieved by recruiting consenting adults presenting to care in acute care settings and a designated COVID outpatient clinic. Vital signs will be acquired using the rPPG app and conventional hospital vital sign monitors simultaneously. Readings will be repeated within 2-5 minutes when time permits. Statistical analysis will be performed to analyze the findings and determine the accuracy and precision of the rPPG app readings.
It is expected that the vital sign readings acquired with the rPPG app will be almost identical to those acquired using hospital-grade monitors for all subjects regardless of age, gender, skin colour, COVID status and relevant comorbidities.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects enrolled in the study will be undergoing vital sign monitoring with the rPPG vital sign monitoring app and the conventional vital sign monitor. Readings with each vital sign monitoring technology will be taken simultaneously on all enrolled subjects.
| Arm | Type | Receives |
|---|---|---|
| rPPG Vital Sign Monitor Readings | Experimental | Device: Remote Photoplethysmography (rPPG) vital sign acquisitionOxygen saturation, heart rate and respiratory rate obtained with the rPPG app. |
| Conventional Vital Sign Monitor Readings | Other | Device: Remote Photoplethysmography (rPPG) vital sign acquisitionOxygen saturation, heart rate and respiratory rate obtained with conventional vital sign monitors and manual respiratory rate counts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons willing to participate and capable of providing informed consent, age of 18 years of more.
- Person able to sit still for the duration of the reading (maximum 2 minutes per reading).
- Persons with freckles, discreet skin pigmentation changes
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Persons who are unable to follow basic instructions due to altered mental status, delirium, dementia or other conditions.
- Age < 18
- Intubated patients and patients requiring masks for supplemental oxygen
- Persons refusing to remove masks, eyewear, or clothing obstructing the face for the duration of readings.
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 |
|---|---|---|
| Remote Photoplethysmography (rPPG) vital sign acquisitionAlso: Welch Allyn Connex Vital Signs Monitor 6000 Series, Welch Allyn Vital Signs Monitor 7000 Series, Masimo Radical 7, Welch Allyn Vital Signs Monitor 6000 Series with Masimo rainbow SET Radical-7R pulse oximeterSubject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation. | Device | Conventional Vital Sign Monitor Readings, rPPG Vital Sign Monitor Readings |
Primary outcome
Accuracy of rPPG heart rate
Time frame: immediate; paired reading
Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.
Accuracy of rPPG oxygen saturation
Time frame: immediate; paired reading
Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.
Accuracy of rPPG respiratory rate
Time frame: immediate; paired reading
Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.
3 secondary outcomes
Reproducibility of rPPG heart rate readings
Time frame: 2-5 minutes
Reproducibility of rPPG oxygen saturation readings
Time frame: 2-5 minutes
Reproducibility of rPPG respiratory rate readings
Time frame: 2-5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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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 Remote Photoplethysmography (rPPG) vital sign acquisition in people with Coronavirus and Cardiac Disease, run by Lady Davis Institute.
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 3 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 28 Jul 2020. 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 Noura Hassan, MD, MPH (514-340-8222 ext. 29743, noura.hassan@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of rPPG heart rate (time frame: immediate; paired reading). The study lists 3 primary outcomes in all. 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 28 Jul 2020.