Implementing Peri-operative Mobile Application for Contactless Vital Signs (MAC-VITAL)

November 1, 2022 updated by: Dr. Frances Chung, University Health Network, Toronto

Implementing Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial

The huge impact of the COVID-19 pandemic on global healthcare systems has prompted 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 measurement of vital signs (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR) and oxyhemoglobin saturation (SpO2) from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments. This study aims to determine whether a mobile app can effectively measure vital signs without any person to person contact and how this technology can be implemented in a peri-operative setting during COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective proof of concept study to be conducted at Toronto Western Hospital,Toronto General Hospital, Hamilton General Hospital (Hamilton, Ontario), Juravinski Hospital (Hamilton, Ontario) and Trillium Health Partners, Mississauga, Ontario. This proof of concept study will determine the feasibility and effectiveness of implementing a contactless mobile application to obtain vital signs from patients in the peri-operative setting. Informed consent to participate in the study will be obtained.

Vital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • 399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia

Description

Inclusion Criteria

  • Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
  • 18 years or older

Exclusion Criteria

  • Refusal to consent for the study
  • Non-English speaking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs measurement
Time Frame: 24 hours
Blood pressure will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
24 hours
Vital signs measurement
Time Frame: 24 hours
Heart rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
24 hours
Vital signs measurement
Time Frame: 24 hours
Breathing rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
24 hours
Vital signs measurement
Time Frame: 24 hours
Heart rate variability will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
24 hours
Vital signs measurement
Time Frame: 24 hours
Oxygen saturation will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 4, 2021

Primary Completion (ACTUAL)

November 30, 2021

Study Completion (ACTUAL)

November 30, 2021

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (ACTUAL)

December 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN CAPCR#20-5683

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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