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

NCT ID: NCT04489407

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronavirus Cardiac Disease Respiratory Disease Vascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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rPPG Vital Sign Monitor Readings

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

Group Type EXPERIMENTAL

Remote Photoplethysmography (rPPG) vital sign acquisition

Intervention Type DEVICE

Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.

Conventional Vital Sign Monitor Readings

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

Group Type OTHER

Remote Photoplethysmography (rPPG) vital sign acquisition

Intervention Type DEVICE

Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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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

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carebook Technologies Inc.

UNKNOWN

Sponsor Role collaborator

Lady Davis Institute

OTHER

Sponsor Role lead

Responsible Party

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Noura Hassan

MD, MPH, FRCSC. Assistant Clinical Professor. Chair, Committee for Assessment of Medical Acts

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Noura Hassan, MD, MPH

Role: CONTACT

514-340-8222 ext. 29743

Other Identifiers

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2021-2376

Identifier Type: -

Identifier Source: org_study_id

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