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

Vital Signs Clinical Trial

— MAC-VITAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04976907
• Other study ID #: 1
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: Nuralogix Corporation
• Contact: Frances Chung, MBBS, FRCPC
• Phone: (416) 670-4253
• Email: Frances.Chung[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vital Signs

Intervention

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.

Locations

Country	Name	City	State
Canada	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

Sponsors (3)

Lead Sponsor	Collaborator
Nuralogix Corporation	Hamilton Health Sciences Corporation, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure difference from reference measurement (mmHg)	Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)	Perioperative
Primary	Diastolic blood pressure difference from reference measurement (mmHg)	Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)	Perioperative
Primary	Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)	Assessed against standard clinical grade instrument: Finger-based pulse oximeter (% oxyhemoglobin saturation)	Perioperative
Primary	Pulse rate difference from reference measurement (beats per minute)	Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)	Perioperative
Primary	Teperature difference from reference measurement (degrees Celsius)	Assessed against standard clinical grade instrument: Forehead digital thermometer (degrees Celsius)	Perioperative
Primary	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
Primary	Obstacles to using the mobile application	Characterization of obstacles to the implementation of the mobile app for perioperative vital sign measurements.	Perioperative
Secondary	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
Secondary	Ease of use survey	Visual analog scale for ease of use.	Perioperative
Secondary	Satisfaction survey	Visual analog scale for satisfaction.	Perioperative
Secondary	Study participation	Includes: Proportion of patients approached who join the study, proportion of patients who own a mobile phone	Perioperative
Secondary	Compliance with measurement protocol	Includes: Proportion of patients who comply with the measurement protocol	Perioperative