Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room
IBPM
1 other identifier
observational
315
1 country
1
Brief Summary
This study aims to evaluate the feasibility and accuracy of a non-contact, camera-based physiological monitoring technology in a perioperative setting (including anesthesia induction, surgery, and recovery).Conventional vital sign monitoring tools-such as ECG leads, blood pressure cuffs, and pulse oximeters-require direct skin contact, which may pose risks of cross-infection or skin injury in vulnerable populations (e.g., newborns or elderly patients). This research utilizes remote Photoplethysmography (rPPG) technology to estimate vital signs, including heart rate, blood pressure, and blood oxygen saturation (SpO2), by analyzing facial video captured via standard camera devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra).The primary goal is to assess the consistency and stability of this non-contact system compared to clinical gold-standard monitors (Masimo Root, SedLine O3, and Radical-7) during actual surgical procedures. The findings will serve as a foundation for developing non-invasive, supplementary monitoring tools in dynamic clinical environments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2026
CompletedFirst Submitted
Initial submission to the registry
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
March 16, 2026
March 1, 2026
2 years
February 3, 2026
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Accuracy of Heart Rate (HR) monitoring
The success rate of non-contact HR measurement using the rPPG software compared to the reference values from the Masimo Root clinical monitoring platform. A "success" is defined as an absolute error within +/- 3 bpm. Unit of Measure: Percentage of successful measurements (%)
From anesthesia induction to recovery (approximately 2-6 hours).
Success rate of Systolic Blood Pressure (SBP) monitoring
The success rate of non-contact SBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 12 mmHg. Unit of Measure: Percentage of successful measurements (%)
From anesthesia induction to recovery (approximately 2-6 hours).
Success rate of Diastolic Blood Pressure (DBP) monitoring
The success rate of non-contact DBP measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 10 mmHg. Unit of Measure: Percentage of successful measurements (%)
From anesthesia induction to recovery (approximately 2-6 hours).
Success rate of Oxygen Saturation (SpO2) monitoring
The success rate of non-contact SpO2 measurement compared to the reference values from the Masimo Root platform. A "success" is defined as an absolute error within +/- 8% (when SpO2 \>/= 80%) or +/- 15% (when SpO2 \< 80%). Unit of Measure: Percentage of successful measurements (%)
From anesthesia induction to recovery (approximately 2-6 hours).
Secondary Outcomes (2)
Mean Absolute Error (MAE) of Heart Rate (HR) across hardware platforms
During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).
Mean Absolute Error (MAE) of Blood Pressure (SBP and DBP) across hardware platforms
During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).
Study Arms (1)
Perioperative Monitoring Group
Surgical patients who will be monitored simultaneously using both the investigational non-contact rPPG software (installed on laptop and mobile devices) and standard clinical monitoring systems (Masimo Root, SedLine O3, and Radical-7) across different surgical phases.
Interventions
A non-invasive, video-based software utilizing remote Photoplethysmography (rPPG) technology to estimate heart rate, blood pressure, and SpO2 by analyzing facial video captured via camera-enabled devices.
Eligibility Criteria
Surgical patients undergoing anesthesia and surgery at Taipei Veterans General Hospital who meet the specified inclusion and exclusion criteria.
You may qualify if:
- Patients aged \>18 years.
- Patients scheduled to undergo surgical procedures under general anesthesia.
- American Society of Anesthesiologists (ASA) Physical Status I, II, or III.
You may not qualify if:
- Patients aged \< 18 years.
- Pregnant patients.
- Patients whose facial images cannot be captured or recognized (e.g., due to surgical drapes, severe edema, or major trauma).
- Patients who refuse to participate or have not signed the informed consent form.
- Other cases deemed unsuitable for the study by the clinical physician or anesthesiologist.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Publications (8)
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PMID: 20588881BACKGROUNDWada M, Hara H, Nakamura M. A change in the pattern of vasospasm after stenting in a patient with vasospastic angina. Heart Vessels. 2006 Nov;21(6):388-91. doi: 10.1007/s00380-006-0920-6. Epub 2006 Nov 27.
PMID: 17143717BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui-Hsuan Ke
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2026
First Posted
March 16, 2026
Study Start
January 8, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2030
Last Updated
March 16, 2026
Record last verified: 2026-03