NCT05165381

Brief Summary

This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG) for contactless vital signs and str5ess index measurements from surgical patients in preoperative care. Our primary objective is to determine the feasibility and validity of using video PPG to collect contactless BP, HR and RR measurements when compared medical-grade instruments. Our secondary objective is to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

December 10, 2021

Last Update Submit

December 18, 2023

Conditions

Keywords

vital signs

Outcome Measures

Primary Outcomes (4)

  • Vital signs measurement

    Blood pressure will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively

    24 hours

  • Vital signs measurement

    Heart rate will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively.\[

    24 hours

  • Vital signs measurement

    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

    4\. HRV and stress index pressure will be measured by video PPG, stress index will be measured with a validated questionnaire

    24 hours

Study Arms (1)

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.

Device: Video PPG

Interventions

Video PPGDEVICE

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.

Contactless vital signs and stress measurement.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients undergoing elective ambulatory surgery with general and/or regional anesthesia;
  • years or older;
  • able to comprehend study instructions in English

You may not qualify if:

  • refusal to consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Toronto, Ontario, M5T2S8, Canada

Location

University Health Network, Toronto Western Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Pham C, Poorzargar K, Panesar D, Lee K, Wong J, Parotto M, Chung F. Video plethysmography for contactless blood pressure and heart rate measurement in perioperative care. J Clin Monit Comput. 2024 Feb;38(1):121-130. doi: 10.1007/s10877-023-01074-6. Epub 2023 Sep 16.

Study Officials

  • Frances Chung, MBBS FRCPC

    University Health Network, Toronto Western Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 21, 2021

Study Start

February 11, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

December 19, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations