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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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ClinicalTrials.gov Identifier: NCT04489407
Recruitment Status : Not yet recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Carebook Technologies Inc.
Information provided by (Responsible Party):
Noura Hassan, Lady Davis Institute

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.


Condition or disease Intervention/treatment Phase
Coronavirus Cardiac Disease Respiratory Disease Vascular Diseases Device: Remote Photoplethysmography (rPPG) vital sign acquisition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study.
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Reproducibility of rPPG heart rate readings [ Time Frame: 2-5 minutes ]
    Comparison of rPPG heart rate results obtained on a given patient on serial readings within 2 minutes of each other.

  2. Reproducibility of rPPG oxygen saturation readings [ Time Frame: 2-5 minutes ]
    Comparison of rPPG oxygen saturation results obtained on a given patient on serial readings within 2 minutes of each other.

  3. Reproducibility of rPPG respiratory rate readings [ Time Frame: 2-5 minutes ]
    Comparison of rPPG respiratory rate results obtained on a given patient on serial readings within 2 minutes of each other.


Other Outcome Measures:
  1. Accuracy of rPPG readings by oxygen saturation level [ Time Frame: immediate; stratified analysis ]
    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%

  2. Accuracy of rPPG readings by skin colour [ Time Frame: immediate; stratified analysis ]
    Analysis of accuracy of rPPG vital sign readings when stratified by skin colour per the Fitzpatrick scale

  3. Accuracy of rPPG readings by gender [ Time Frame: immediate; stratified analysis ]
    Analysis of accuracy of rPPG vital sign readings when stratified for gender

  4. Accuracy of rPPG readings by age [ Time Frame: immediate; stratified analysis ]
    Analysis of accuracy of rPPG vital sign readings when stratified by age group

  5. Accuracy of rPPG readings by comorbidity [ Time Frame: immediate; stratified analysis ]
    Analysis of accuracy of rPPG vital sign readings when stratified for COVID, respiratory conditions, cardiac conditions and vascular conditions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489407


Contacts
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Contact: Noura Hassan, MD, MPH 514-340-8222 ext 29743 noura.hassan@mcgill.ca

Sponsors and Collaborators
Lady Davis Institute
Carebook Technologies Inc.
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Responsible Party: Noura Hassan, MD, MPH, FRCSC. Assistant Clinical Professor. Chair, Committee for Assessment of Medical Acts, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT04489407    
Other Study ID Numbers: 2021-2376
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noura Hassan, Lady Davis Institute:
oximetry
pulse oximetry
respiratory rate
remote photoplethysmography
coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Respiration Disorders
Respiratory Tract Diseases
Vascular Diseases
Heart Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Cardiovascular Diseases