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
About this trial
This is an interventional other trial for Coronavirus focused on measuring oximetry, pulse oximetry, respiratory rate, remote photoplethysmography, coronavirus
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).
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
NCT ID
NCT04489407
First Posted
July 23, 2020
Last Updated
July 23, 2020
Sponsor
Lady Davis Institute
Collaborators
Carebook Technologies Inc.
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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Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.
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