Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement

NCT ID: NCT04976907

Last Updated: 2021-09-14

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-10-01

Brief Summary

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The impact of the coronavirus disease (COVID)-19 pandemic on global healthcare systems has prompted a search for novel tools to stem the tide. New digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. This proof of concept study will determine the feasibility and effectiveness of implementing a mobile application for contactless screening and vital signs measurement (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR), oxyhemoglobin saturation (SpO2), temperature from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments.

Detailed Description

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This study aims to determine whether a mobile app can accurately and reliably measure vital signs without any person to person contact, and the feasibility of implementing it in a peri-operative setting (e.g., during COVID-19). The validity and feasibility of the Anura™ Research app will be assessed during inpatient visits in preparation for and after surgery, and it will be compared with standard medical monitors.

Conditions

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Vital Signs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Perioperative patients

Patients undergoing perioperative assessment of vital signs.

Contactless vital sign information collection

Intervention Type DEVICE

Collection of facial blood flow and temperature information via conventional and infrared/thermal video of the face for the purpose of estimating vital signs using machine learning-based computational models.

Interventions

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Contactless vital sign information collection

Collection of facial blood flow and temperature information via conventional and infrared/thermal video of the face for the purpose of estimating vital signs using machine learning-based computational models.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo elective surgery under general and/or regional anesthesia
* 18+ years of age

Exclusion Criteria

* Refusal to consent for the study
* Non-English speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

Nuralogix Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frances Chung, MBBS, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Hamilton General Hospital (Hamilton Health Sciences)

Hamilton, Ontario, Canada

Site Status

Juravinski Hospital (Hamilton Health Sciences)

Hamilton, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Frances Chung, MBBS, FRCPC

Role: CONTACT

(416) 670-4253

Facility Contacts

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Russel Brown, MD

Role: primary

905-521-2100 ext. 44890

Russel Brown, MD

Role: primary

905-521-2100 ext. 44890

Matteo Parotto, MD PhD

Role: primary

(416) 340-3567

Frances Chung, MBBS, FRCPC

Role: primary

(416) 670-4253

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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