<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04489407</url>
  </required_header>
  <id_info>
    <org_study_id>2021-2376</org_study_id>
    <nct_id>NCT04489407</nct_id>
  </id_info>
  <brief_title>Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.</brief_title>
  <official_title>Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lady Davis Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carebook Technologies Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lady Davis Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contactless and widely available health monitoring technologies are of growing interest in&#xD;
      the context of the worldwide COVID-19 pandemic. Remote photoplethysmography (rPPG) is a&#xD;
      well-studied technology that interprets variations in skin colour related to blood flow&#xD;
      which, when analysed with complex mathematical algorithm, generates vital sign readings. This&#xD;
      technology has been refined and embedded in a smartphone app designed to acquire heart rate,&#xD;
      respiratory rate and oxygen saturation using a front-facing smartphone camera.&#xD;
&#xD;
      Preliminary data comparing the accuracy of smartphone rPPG readings with conventional vital&#xD;
      sign monitor readings are promising; however, less than 5% of the population studied in the&#xD;
      app development phase had oxygen saturation levels below 95% making it impossible to ensure&#xD;
      reliability in these populations.&#xD;
&#xD;
      The goal of this study is to compare readings acquired using this rPPG app with the readings&#xD;
      from hospital grade, Health Canada approved vital signs monitors used in healthcare settings&#xD;
      with a focus on subject with low oxygen saturations. We will also study other&#xD;
      sociodemographic and clinical features that may influence the accuracy of the readings. This&#xD;
      will be achieved by recruiting consenting adults presenting to care in acute care settings&#xD;
      and a designated COVID outpatient clinic. Vital signs will be acquired using the rPPG app and&#xD;
      conventional hospital vital sign monitors simultaneously. Readings will be repeated within&#xD;
      2-5 minutes when time permits. Statistical analysis will be performed to analyze the findings&#xD;
      and determine the accuracy and precision of the rPPG app readings.&#xD;
&#xD;
      It is expected that the vital sign readings acquired with the rPPG app will be almost&#xD;
      identical to those acquired using hospital-grade monitors for all subjects regardless of age,&#xD;
      gender, skin colour, COVID status and relevant comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of rPPG heart rate</measure>
    <time_frame>immediate; paired reading</time_frame>
    <description>Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of rPPG oxygen saturation</measure>
    <time_frame>immediate; paired reading</time_frame>
    <description>Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of rPPG respiratory rate</measure>
    <time_frame>immediate; paired reading</time_frame>
    <description>Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of rPPG heart rate readings</measure>
    <time_frame>2-5 minutes</time_frame>
    <description>Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of rPPG oxygen saturation readings</measure>
    <time_frame>2-5 minutes</time_frame>
    <description>Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of rPPG respiratory rate readings</measure>
    <time_frame>2-5 minutes</time_frame>
    <description>Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Accuracy of rPPG readings by oxygen saturation level</measure>
    <time_frame>immediate; stratified analysis</time_frame>
    <description>Analysis of accuracy of rPPG vital sign readings when stratified by oxygen saturation per conventional monitors stratified as follows: 95-100%; 90-94%; 85-89%; Less than 85%</description>
  </other_outcome>
  <other_outcome>
    <measure>Accuracy of rPPG readings by skin colour</measure>
    <time_frame>immediate; stratified analysis</time_frame>
    <description>Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Accuracy of rPPG readings by gender</measure>
    <time_frame>immediate; stratified analysis</time_frame>
    <description>Analysis of accuracy of rPPG vital sign readings when stratified for gender</description>
  </other_outcome>
  <other_outcome>
    <measure>Accuracy of rPPG readings by age</measure>
    <time_frame>immediate; stratified analysis</time_frame>
    <description>Analysis of accuracy of rPPG vital sign readings when stratified by age group</description>
  </other_outcome>
  <other_outcome>
    <measure>Accuracy of rPPG readings by comorbidity</measure>
    <time_frame>immediate; stratified analysis</time_frame>
    <description>Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Coronavirus</condition>
  <condition>Cardiac Disease</condition>
  <condition>Respiratory Disease</condition>
  <condition>Vascular Diseases</condition>
  <arm_group>
    <arm_group_label>rPPG Vital Sign Monitor Readings</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxygen saturation, heart rate and respiratory rate obtained with the rPPG app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Vital Sign Monitor Readings</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oxygen saturation, heart rate and respiratory rate obtained with conventional vital sign monitors and manual respiratory rate counts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remote Photoplethysmography (rPPG) vital sign acquisition</intervention_name>
    <description>Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.</description>
    <arm_group_label>Conventional Vital Sign Monitor Readings</arm_group_label>
    <arm_group_label>rPPG Vital Sign Monitor Readings</arm_group_label>
    <other_name>Welch Allyn Connex Vital Signs Monitor 6000 Series</other_name>
    <other_name>Welch Allyn Vital Signs Monitor 7000 Series</other_name>
    <other_name>Masimo Radical 7</other_name>
    <other_name>Welch Allyn Vital Signs Monitor 6000 Series with Masimo rainbow SET Radical-7R pulse oximeter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons willing to participate and capable of providing informed consent, age of 18&#xD;
             years of more.&#xD;
&#xD;
          -  Person able to sit still for the duration of the reading (maximum 2 minutes per&#xD;
             reading).&#xD;
&#xD;
          -  Persons with freckles, discreet skin pigmentation changes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Persons who are unable to follow basic instructions due to altered mental status,&#xD;
             delirium, dementia or other conditions.&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Intubated patients and patients requiring masks for supplemental oxygen&#xD;
&#xD;
          -  Persons refusing to remove masks, eyewear, or clothing obstructing the face for the&#xD;
             duration of readings.&#xD;
&#xD;
          -  Persons with facial tattoos, large birthmarks or other skin alterations (scars,&#xD;
             hemangiomas) on their nose or upper cheeks (cheekbones).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Noura Hassan, MD, MPH</last_name>
    <phone>514-340-8222</phone>
    <phone_ext>29743</phone_ext>
    <email>noura.hassan@mcgill.ca</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lady Davis Institute</investigator_affiliation>
    <investigator_full_name>Noura Hassan</investigator_full_name>
    <investigator_title>MD, MPH, FRCSC. Assistant Clinical Professor. Chair, Committee for Assessment of Medical Acts</investigator_title>
  </responsible_party>
  <keyword>oximetry</keyword>
  <keyword>pulse oximetry</keyword>
  <keyword>respiratory rate</keyword>
  <keyword>remote photoplethysmography</keyword>
  <keyword>coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04489407
org study id: 2021-2376
nct id: NCT04489407
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Other
masking: None (Open Label)
measure: Accuracy of rPPG heart rate
time frame: immediate; paired reading
description: Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.
measure: Accuracy of rPPG oxygen saturation
time frame: immediate; paired reading
description: Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.
measure: Accuracy of rPPG respiratory rate
time frame: immediate; paired reading
description: Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.
measure: Reproducibility of rPPG heart rate readings
time frame: 2-5 minutes
description: Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.
measure: Reproducibility of rPPG oxygen saturation readings
time frame: 2-5 minutes
description: Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.
measure: Reproducibility of rPPG respiratory rate readings
time frame: 2-5 minutes
description: Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.
measure: Accuracy of rPPG readings by oxygen saturation level
time frame: immediate; stratified analysis
description: Analysis of accuracy of rPPG vital sign readings when stratified by oxygen saturation per conventional monitors stratified as follows: 95-100%; 90-94%; 85-89%; Less than 85%
measure: Accuracy of rPPG readings by skin colour
time frame: immediate; stratified analysis
description: Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale
measure: Accuracy of rPPG readings by gender
time frame: immediate; stratified analysis
description: Analysis of accuracy of rPPG vital sign readings when stratified for gender
measure: Accuracy of rPPG readings by age
time frame: immediate; stratified analysis
description: Analysis of accuracy of rPPG vital sign readings when stratified by age group
measure: Accuracy of rPPG readings by comorbidity
time frame: immediate; stratified analysis
description: Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.
arm group label: rPPG Vital Sign Monitor Readings
arm group type: Experimental
description: Oxygen saturation, heart rate and respiratory rate obtained with the rPPG app.
arm group label: Conventional Vital Sign Monitor Readings
arm group type: Other
description: Oxygen saturation, heart rate and respiratory rate obtained with conventional vital sign monitors and manual respiratory rate counts.
intervention type: Device
intervention name: Remote Photoplethysmography (rPPG) vital sign acquisition
description: Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.
arm group label: Conventional Vital Sign Monitor Readings
arm group label: rPPG Vital Sign Monitor Readings
other name: Welch Allyn Connex Vital Signs Monitor 6000 Series
other name: Welch Allyn Vital Signs Monitor 7000 Series
other name: Masimo Radical 7
other name: Welch Allyn Vital Signs Monitor 6000 Series with Masimo rainbow SET Radical-7R pulse oximeter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Noura Hassan, MD, MPH
phone: 514-340-8222
phone ext: 29743
email: noura.hassan@mcgill.ca
responsible party type: Principal Investigator
investigator affiliation: Lady Davis Institute
investigator full name: Noura Hassan
investigator title: MD, MPH, FRCSC. Assistant Clinical Professor. Chair, Committee for Assessment of Medical Acts
mesh term: Coronavirus Infections
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Vascular Diseases
mesh term: Heart Diseases
sharing ipd: No