Implementing Peri-operative Mobile Application for Contactless Vital Signs

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.

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Key information

Conditions

Blood Pressure, Heart Rate, Breathing Rate and Oxygen Level

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia

Toronto, Ontario, M5T2S8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vital sign measurement

Diagnostic Test

Primary outcomes

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.
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.
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.
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.
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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: MAC-VITAL

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Dec 1, 2020
Registry last updated: Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.