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Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.

Primary Purpose

Coronavirus, Cardiac Disease, Respiratory Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote Photoplethysmography (rPPG) vital sign acquisition
Sponsored by
Lady Davis Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronavirus focused on measuring oximetry, pulse oximetry, respiratory rate, remote photoplethysmography, coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    rPPG Vital Sign Monitor Readings

    Conventional Vital Sign Monitor Readings

    Arm Description

    Oxygen saturation, heart rate and respiratory rate obtained with the rPPG app.

    Oxygen saturation, heart rate and respiratory rate obtained with conventional vital sign monitors and manual respiratory rate counts.

    Outcomes

    Primary Outcome Measures

    Accuracy of rPPG heart rate
    Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each 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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    July 23, 2020
    Last Updated
    July 23, 2020
    Sponsor
    Lady Davis Institute
    Collaborators
    Carebook Technologies Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04489407
    Brief Title
    Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.
    Official Title
    Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2020 (Anticipated)
    Primary Completion Date
    October 30, 2020 (Anticipated)
    Study Completion Date
    November 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lady Davis Institute
    Collaborators
    Carebook Technologies Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronavirus, Cardiac Disease, Respiratory Disease, Vascular Diseases
    Keywords
    oximetry, pulse oximetry, respiratory rate, remote photoplethysmography, coronavirus

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rPPG Vital Sign Monitor Readings
    Arm Type
    Experimental
    Arm Description
    Oxygen saturation, heart rate and respiratory rate obtained with the rPPG app.
    Arm Title
    Conventional Vital Sign Monitor Readings
    Arm Type
    Other
    Arm Description
    Oxygen saturation, heart rate and respiratory rate obtained with conventional vital sign monitors and manual respiratory rate counts.
    Intervention Type
    Device
    Intervention Name(s)
    Remote Photoplethysmography (rPPG) vital sign acquisition
    Other Intervention Name(s)
    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
    Intervention Description
    Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.
    Primary Outcome Measure Information:
    Title
    Accuracy of rPPG heart rate
    Description
    Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.
    Time Frame
    immediate; paired reading
    Title
    Accuracy of rPPG oxygen saturation
    Description
    Accuracy of rPPG oxygen saturation compared to conventional vital sign monitor oxygen saturation readings. Comparison of discrepancy within each paired reading set.
    Time Frame
    immediate; paired reading
    Title
    Accuracy of rPPG respiratory rate
    Description
    Accuracy of rPPG respiratory rate compared to manual counting of respiratory rate over 60 seconds. Comparison of discrepancy within each paired reading set.
    Time Frame
    immediate; paired reading
    Secondary Outcome Measure Information:
    Title
    Reproducibility of rPPG heart rate readings
    Description
    Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.
    Time Frame
    2-5 minutes
    Title
    Reproducibility of rPPG oxygen saturation readings
    Description
    Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.
    Time Frame
    2-5 minutes
    Title
    Reproducibility of rPPG respiratory rate readings
    Description
    Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.
    Time Frame
    2-5 minutes
    Other Pre-specified Outcome Measures:
    Title
    Accuracy of rPPG readings by oxygen saturation level
    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%
    Time Frame
    immediate; stratified analysis
    Title
    Accuracy of rPPG readings by skin colour
    Description
    Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale
    Time Frame
    immediate; stratified analysis
    Title
    Accuracy of rPPG readings by gender
    Description
    Analysis of accuracy of rPPG vital sign readings when stratified for gender
    Time Frame
    immediate; stratified analysis
    Title
    Accuracy of rPPG readings by age
    Description
    Analysis of accuracy of rPPG vital sign readings when stratified by age group
    Time Frame
    immediate; stratified analysis
    Title
    Accuracy of rPPG readings by comorbidity
    Description
    Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.
    Time Frame
    immediate; stratified analysis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noura Hassan, MD, MPH
    Phone
    514-340-8222
    Ext
    29743
    Email
    noura.hassan@mcgill.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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