Clinical trial NCT04648111: Implementing Peri-operative Mobile Application for Contactless Vital Signs
Official title: Implementing Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure, Heart Rate, Breathing Rate and Oxygen Level
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Vital signs measurement
timeFrame: 24 hours
measure: Vital signs measurement
timeFrame: 24 hours
measure: Vital signs measurement
timeFrame: 24 hours
measure: Vital signs measurement
timeFrame: 24 hours
measure: Vital signs measurement
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: 399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
state: Ontario
Study officials:
References: