Vital Signs Clinical Trial
— MAC-VITALOfficial title:
Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
NCT number | NCT04976907 |
Other study ID # | 1 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | October 1, 2022 |
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Nuralogix Corporation | Hamilton Health Sciences Corporation, University Health Network, Toronto |
Canada,
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 |
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