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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vital Signs

Intervention / Treatment
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* Device: Contactless vital sign information collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perioperative patients<br>Patients undergoing perioperative assessment of vital signs. | Device: Contactless vital sign information collection<br>* 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.<br>|

What is the study measuring?
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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 |