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ClinicalTrials.gov ID

NCT04976907

Lead Sponsor

Nuralogix CorporationINDUSTRY

Overall Status

Unknown status

Study Type

Observational

Enrollment

200Estimated

Last Update Posted

Sep 14, 2021Actual

Start Date

Oct 1, 2021Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Oct 1, 2022Estimated

Official Title

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

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.

• Vital Signs

• Contactless vital sign information collection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Nuralogix CorporationINDUSTRY

Collaborators

University Health Network, TorontoOTHER

Hamilton Health Sciences CorporationOTHER

Matteo.Parotto@uhn.ca(416) 340-3567