- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165381
Contactless Vital Signs Measurement
Video Plethysmography for Contactless Vital Signs Measurement: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The huge impact of the COVID-19 pandemic on global healthcare systems has given rise to an increased need for virtual care. This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG)for contactless vital signs measurements such as blood pressure (BP), heartrate (HR), respiratory rate (RR) and heart rate variability (HRV) from surgical patients in preoperative care. We also aim to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.
This study aims to assess how video PPG technology can be implemented in a clinical and telemedicine. If proven to be effective, this technology can be integrated into any smartphone or tablet and will allow users to monitor their vital signs with just a 1.5-minute video.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5T2S8
- 399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
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Toronto, Ontario, Canada
- University Health Network, Toronto Western Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients undergoing elective ambulatory surgery with general and/or regional anesthesia;
- 18 years or older;
- able to comprehend study instructions in English
Exclusion Criteria:
- refusal to consent for the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Contactless vital signs and stress measurement.
Contactless vital signs and stress measurement.
Eligible participants will agree to have a 1.5-minute facial video recorded using an iPad.
Video will be processed through a specialized algorithm to obtain BP, HR, RR, HRV and stress index.
measurements.
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Contactless vital signs and stress measurement using video PPG technology.
An iPad will be used to record a video of the participant's, which can then be converted to vital signs using a specialized algorithm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vital signs measurement
Time Frame: 24 hours
|
Blood pressure will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively
|
24 hours
|
Vital signs measurement
Time Frame: 24 hours
|
Heart rate will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively.[
|
24 hours
|
Vital signs measurement
Time Frame: 24 hours
|
Breathing rate will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively
|
24 hours
|
HRV and stress index pressure
Time Frame: 24 hours
|
4. HRV and stress index pressure will be measured by video PPG, stress index will be measured with a validated questionnaire
|
24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frances Chung, MBBS FRCPC, University Health Network, Toronto Western Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-6075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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