An observational study in Vital Signs, sponsored by Nuralogix Corporation. Status unknown at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by Nuralogix Corporation · Observational
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.
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.
Nuralogix Corporation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled to undergo elective surgery under general and/or regional anesthesia.
Exclusion Criteria:
Patients undergoing perioperative assessment of vital signs.
Device: Contactless vital sign information collection
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.
Systolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Time frame: Perioperative
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Time frame: Perioperative
Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (% oxyhemoglobin saturation)
Time frame: Perioperative
Pulse rate difference from reference measurement (beats per minute)
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)
Time frame: Perioperative
Teperature difference from reference measurement (degrees Celsius)
Assessed against standard clinical grade instrument: Forehead digital thermometer (degrees Celsius)
Time frame: 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)
Time frame: Perioperative
Obstacles to using the mobile application
Characterization of obstacles to the implementation of the mobile app for perioperative vital sign measurements.
Time frame: Perioperative
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).
Time frame: Perioperative
Ease of use survey
Visual analog scale for ease of use.
Time frame: Perioperative
Satisfaction survey
Visual analog scale for satisfaction.
Time frame: Perioperative
Study participation
Includes: Proportion of patients approached who join the study, proportion of patients who own a mobile phone
Time frame: Perioperative
Compliance with measurement protocol
Includes: Proportion of patients who comply with the measurement protocol
Time frame: Perioperative
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Nuralogix Corporation