Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs MonitoringNCT05165381
Contactless Vital Signs Measurement
An observational study of Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs Monitoring and Vital Signs Monitoring, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs Monitoring, Vital Signs Monitoring
- What is being tested?
- Video PPG
- Type of treatment
- Medical device
- How many people
- 216 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Feb 2022to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
Who may be able to join
- patients undergoing elective ambulatory surgery with general and/or regional anesthesia;
- 18 years or older;
- able to comprehend study instructions in English
Who cannot join
- refusal to consent for the study
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
Toronto, Ontario, M5T2S8
University Health Network, Toronto Western Hospital
Toronto, Ontario
About this study
Official title: Video Plethysmography for Contactless Vital Signs Measurement: A Pilot Study
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.
Read the 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.
- Conditions
- Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs Monitoring, Vital Signs Monitoring
- Being tested
- Video PPG
- Keywords
- vital signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Video PPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs measurement
Blood pressure will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively
Measured: 24 hours
Vital signs measurement
Heart rate will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively.[
Measured: 24 hours
Vital signs measurement
Breathing rate will be measured by using both video PPG and standard medical grade blood pressure machine preoperatively
Measured: 24 hours
HRV and stress index pressure
- HRV and stress index pressure will be measured by video PPG, stress index will be measured with a validated questionnaire
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start11 Feb 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs MonitoringStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frances Chung, MBBS FRCPC, Principal investigator, University Health Network, Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165381
- Sponsor's protocol ID
- 21-6075
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37715858
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Plethysmography for Contactless Vital Signs Measurement: A Pilot Study
- ClinicalTrials.gov ID
- NCT05165381
- Acronym / sponsor ID
- 21-6075
- Conditions
- Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs Monitoring, Vital Signs Monitoring
- Keywords
- vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contactless vital signs and stress measurement. | – | Device: Video PPGContactless 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
Key inclusion criteria (3 listed)
- patients undergoing elective ambulatory surgery with general and/or regional anesthesia;
- 18 years or older;
- able to comprehend study instructions in English
Key exclusion criteria (1 listed)
- refusal to consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video PPGContactless 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. | Device | Contactless vital signs and stress measurement. |
Primary outcome
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
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.[
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 37715858Pham 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Chung, MBBS FRCPC principal investigator
University Health Network, Toronto Western Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs Monitoring and Vital Signs Monitoring, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital signs measurement (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05165381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.