Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vital Signs
- Sponsor
- Nuralogix Corporation
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Systolic blood pressure difference from reference measurement (mmHg)
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Systolic blood pressure difference from reference measurement (mmHg)
Time Frame: Perioperative
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Diastolic blood pressure difference from reference measurement (mmHg)
Time Frame: Perioperative
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)
Time Frame: Perioperative
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (% oxyhemoglobin saturation)
Pulse rate difference from reference measurement (beats per minute)
Time Frame: Perioperative
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)
Teperature difference from reference measurement (degrees Celsius)
Time Frame: Perioperative
Assessed against standard clinical grade instrument: Forehead digital thermometer (degrees Celsius)
Respiratory rate difference from reference measurement (breaths per minute)
Time Frame: Perioperative
Assessed against standard clinical grade instrument: Visual count of chest rise and fall (breaths per minute)
Obstacles to using the mobile application
Time Frame: Perioperative
Characterization of obstacles to the implementation of the mobile app for perioperative vital sign measurements.
Secondary Outcomes
- Detection rate of clinically meaningful changes of vital signs(Perioperative)
- Ease of use survey(Perioperative)
- Satisfaction survey(Perioperative)
- Study participation(Perioperative)
- Compliance with measurement protocol(Perioperative)