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

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 Overview

• Status: Unknown
• Conditions: Vascular Diseases; Coronavirus; Respiratory Disease; Cardiac Disease
• Intervention / Treatment: Device: Remote Photoplethysmography (rPPG) vital sign acquisition

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noura Hassan, MD, MPH; Phone Number: 29743 514-340-8222; Email: noura.hassan@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rPPG Vital Sign Monitor Readings; Oxygen saturation, heart rate and respiratory rate obtained with the rPPG app.	Device: Remote Photoplethysmography (rPPG) vital sign acquisition; Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.; Other Names: 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
Other: Conventional Vital Sign Monitor Readings; Oxygen saturation, heart rate and respiratory rate obtained with conventional vital sign monitors and manual respiratory rate counts.	Device: Remote Photoplethysmography (rPPG) vital sign acquisition; Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of rPPG heart rate	Accuracy of rPPG heart rate compared to conventional vital sign monitor heart rate readings. Comparison of each paired reading.	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.	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.	immediate; paired reading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	2-5 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of rPPG readings by oxygen saturation level	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%	immediate; stratified analysis
Accuracy of rPPG readings by skin colour	Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale	immediate; stratified analysis
Accuracy of rPPG readings by gender	Analysis of accuracy of rPPG vital sign readings when stratified for gender	immediate; stratified analysis
Accuracy of rPPG readings by age	Analysis of accuracy of rPPG vital sign readings when stratified by age group	immediate; stratified analysis
Accuracy of rPPG readings by comorbidity	Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.	immediate; stratified analysis

Collaborators and Investigators

• Sponsor: Lady Davis Institute
• Collaborators: Carebook Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: coronavirus; oximetry; pulse oximetry; respiratory rate; remote photoplethysmography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Heart Diseases; Coronavirus Infections; Vascular Diseases; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2021-2376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No