Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vital Signs
• Intervention / Treatment: Device: Contactless vital sign information collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Frances Chung, MBBS, FRCPC; Phone Number: (416) 670-4253; Email: Frances.Chung@uhn.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital (Hamilton Health Sciences)
      • Contact: Russel Brown, MD; Phone Number: 44890 905-521-2100; Email: russell.brown@medportal.ca
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Hospital (Hamilton Health Sciences)
      • Contact: Russel Brown, MD; Phone Number: 44890 905-521-2100; Email: russell.brown@medportal.ca
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
      • Contact: Matteo Parotto, MD PhD; Phone Number: (416) 340-3567; Email: Matteo.Parotto@uhn.ca
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital, University Health Network
      • Contact: Frances Chung, MBBS, FRCPC; Phone Number: (416) 670-4253; Email: Frances.Chung@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled to undergo elective surgery under general and/or regional anesthesia.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Perioperative patients; Patients undergoing perioperative assessment of vital signs.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure difference from reference measurement (mmHg)	Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)	Perioperative
Diastolic blood pressure difference from reference measurement (mmHg)	Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)	Perioperative
Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)	Assessed against standard clinical grade instrument: Finger-based pulse oximeter (% oxyhemoglobin saturation)	Perioperative
Pulse rate difference from reference measurement (beats per minute)	Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)	Perioperative
Teperature difference from reference measurement (degrees Celsius)	Assessed against standard clinical grade instrument: Forehead digital thermometer (degrees Celsius)	Perioperative
Respiratory rate difference from reference measurement (breaths per minute)	Assessed against standard clinical grade instrument: Visual count of chest rise and fall (breaths per minute)	Perioperative
Obstacles to using the mobile application	Characterization of obstacles to the implementation of the mobile app for perioperative vital sign measurements.	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of clinically meaningful changes of vital signs	Proportion of clinically meaningful vital sign changes detected postoperatively by the mobile application (relative to vital sign changes detected by standard clinical grade instruments).	Perioperative
Ease of use survey	Visual analog scale for ease of use.	Perioperative
Satisfaction survey	Visual analog scale for satisfaction.	Perioperative
Study participation	Includes: Proportion of patients approached who join the study, proportion of patients who own a mobile phone	Perioperative
Compliance with measurement protocol	Includes: Proportion of patients who comply with the measurement protocol	Perioperative

Collaborators and Investigators

• Sponsor: Nuralogix Corporation
• Collaborators: University Health Network, Toronto; Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Frances Chung, MBBS, FRCPC, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No