Implementing Peri-operative Mobile Application for Contactless Vital Signs

NCT04648111 | Completed

• 1 other identifier: UHN CAPCR#20-5683
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The huge impact of the COVID-19 pandemic on global healthcare systems has prompted 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 measurement of vital signs (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR) and oxyhemoglobin saturation (SpO2) 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 effectively measure vital signs without any person to person contact and how this technology can be implemented in a peri-operative setting during COVID-19.

Conditions

Blood Pressure, Heart Rate, Breathing Rate and Oxygen Level

Outcome Measures

Primary Outcomes (5)

• Vital signs measurement

  Blood pressure will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.

  24 hours

• Vital signs measurement

  Heart rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.

  24 hours

• Vital signs measurement

  Breathing rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.

  24 hours

• Vital signs measurement

  Heart rate variability will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.

  24 hours

• Vital signs measurement

  Oxygen saturation will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.

  24 hours

Interventions

Vital sign measurement DIAGNOSTIC_TEST

Vital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia

You may qualify if:

• Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
• years or older

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Interventions

Vital Signs

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 1, 2020
• Study Start: June 4, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)