Clinical trial NCT04976907: Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement
Official title: Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vital Signs
Lead sponsor: Nuralogix Corporation
Sponsor class: INDUSTRY
Collaborators: name: University Health Network, Toronto
name: Hamilton Health Sciences Corporation
First posted: 2021-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo elective surgery under general and/or regional anesthesia.

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.

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

Primary outcomes:
measure: Systolic blood pressure difference from reference measurement (mmHg)
timeFrame: Perioperative
measure: Diastolic blood pressure difference from reference measurement (mmHg)
timeFrame: Perioperative
measure: Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)
timeFrame: Perioperative
measure: Pulse rate difference from reference measurement (beats per minute)
timeFrame: Perioperative
measure: Teperature difference from reference measurement (degrees Celsius)
timeFrame: Perioperative
measure: Respiratory rate difference from reference measurement (breaths per minute)
timeFrame: Perioperative
measure: Obstacles to using the mobile application
timeFrame: Perioperative
Secondary outcomes:
measure: Detection rate of clinically meaningful changes of vital signs
timeFrame: Perioperative
measure: Ease of use survey
timeFrame: Perioperative
measure: Satisfaction survey
timeFrame: Perioperative
measure: Study participation
timeFrame: Perioperative
measure: Compliance with measurement protocol
timeFrame: Perioperative
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital (Hamilton Health Sciences)
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital (Hamilton Health Sciences)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Frances Chung, MBBS, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: