- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07035795
- Original Trial
Cardiovascular Physiological Signal Recording Project
Vital sign monitoring is important for patients, especially those with underlying cardiovascular diseases. Traditional monitoring including SaO2, blood pressure, pulse, rhythm monitoring can be cumbersome, with wires and cuff attached to a patient. This can lead to reduced compliance, especially in uncooperative patients or young kids. The use of photoplethysmography (PPG) is simple and is widely used clinically to achieve continuous monitoring of SaO2, respiratory rate and pulse rate. PPG also contains important physiological signals that can correlate with blood pressure.
Remote PPG (rPPG) with can be collected by cameras. This is being developed to achieve contactless monitoring. Theoretically, by analyzing video recording, the fluctuation of intensity of lights reflected from patients' body surface can be measured. Physiological parameters such as heart rate, SaO2, and blood pressure can then be calculated. However, because of environmental signal contamination, motion artefacts and other limitations, rPPG remains inaccurate for routine clinical use. To improve accuracy of PPG recordings, machine learning approach has been attempted. This study aims to gather physiological data from patients to train these models.
Study Overview
Status
Conditions
Detailed Description
This is an observational study. The physiological signal collected includes blood pressure, pulse rate, respiratory rate, SaO2, cardiac rhythm. PPG signals will be extracted from dedicated devices such as commercially available SaO2 monitors. Remote PPG signals will be collected if patient consent for video recording.
Patient demographic data, including age, sex, past medical history, medication history, body weight and height, etc, may be collected to validate training of this model.
After collection of these data, machine learning approach will be used to analyze these recordings and correlate them with PPG and rPPG data.
After their enrollment, during the duration of the study, patient's electronic record may be accessed in the next 5 years to explore any association of PPG or rPPG signals and long term outcome.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tsz Kin Mark Tam
- Phone Number: 852 35051750
- Email: marktam@cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- Prince of Wales Hospital
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Contact:
- Tammy Yeung
- Phone Number: 852 35051750
- Email: tammyooyeung@cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients > 18 years old
- Has a known medical disease
- Able to comply with recording of physiological signals
Exclusion Criteria:
1. Patients who are not able to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Recording of PPG and rPPG
The physiological signal collected includes blood pressure, pulse rate, respiratory rate, SaO2, cardiac rhythm.
PPG signals will be extracted from dedicated devices such as commercially available SaO2 monitors.
Remote PPG signals will be collected if patient consent for video recording.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of a model using PPG and rPPG
Time Frame: through study completion, an average of 4 years
|
To develop a model using PPG and rPPG to accurately measure physiological signals
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through study completion, an average of 4 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PPG study
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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