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

• Conditions: Vital Signs
• Interventions: Device: Contactless vital sign information collection

• Registration Number: NCT04976907
• Lead Sponsor: Nuralogix Corporation

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-14
• Study Start: 2021-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Perioperative patients	Contactless vital sign information collection	Patients undergoing perioperative assessment of vital signs.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Hamilton General Hospital (Hamilton Health Sciences); 🇨🇦 Hamilton, Ontario, Canada

Juravinski Hospital (Hamilton Health Sciences); 🇨🇦 Hamilton, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada