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

NCT04976907 | Unknown

• 1 other identifier: 1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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

Study Arms (1)

Perioperative patients

Patients undergoing perioperative assessment of vital signs.

Device: Contactless vital sign information collection

Interventions

Contactless vital sign information collection DEVICE

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.

Perioperative patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled to undergo elective surgery under general and/or regional anesthesia.

You may qualify if:

• Patients scheduled to undergo elective surgery under general and/or regional anesthesia
• + years of age

You may not qualify if:

• Refusal to consent for the study
• Non-English speaking

Sponsors & Collaborators

• Nuralogix Corporation: lead
• University Health Network, Toronto: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (4)

Hamilton General Hospital (Hamilton Health Sciences)

Hamilton, Ontario, L8L 2X2, Canada

Location

Juravinski Hospital (Hamilton Health Sciences)

Hamilton, Ontario, L8V 1C3, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

• Frances Chung, MBBS, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances Chung, MBBS, FRCPC

CONTACT

(416) 670-4253; Frances.Chung@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

CA (4)