Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTaipei Veterans General Hospital, Taiwan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >18 years.
Patients scheduled to undergo surgical procedures under general anesthesia.
American Society of Anesthesiologists (ASA) Physical Status I, II, or III.
Disqualifiers
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.
Trial population
Surgical patients undergoing anesthesia and surgery at Taipei Veterans General Hospital who meet the specified inclusion and exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-contact rPPG software
DeviceA 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.
Treatment groups
315 Participants
are divided into 1 treatment groupGroup A: Perioperative Monitoring Group1 intervention
Trial outcomes
Primary outcomes
1
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 (%)
Time frame
From anesthesia induction to recovery (approximately 2-6 hours).2
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 (%)
Time frame
From anesthesia induction to recovery (approximately 2-6 hours).3
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 (%)
Time frame
From anesthesia induction to recovery (approximately 2-6 hours).4
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 (%)
Time frame
From anesthesia induction to recovery (approximately 2-6 hours).Secondary outcomes
1
Mean Absolute Error (MAE) of Heart Rate (HR) across hardware platforms
Evaluation of the Heart Rate measurement consistency among three devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra) compared to the Masimo Root monitor. The measurement tool is the rPPG software. Consistency will be assessed by calculating the Mean Absolute Error (MAE) of heart rate. Unit of Measure： Beats per minute (bpm)
Time frame
During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).2
Mean Absolute Error (MAE) of Blood Pressure (SBP and DBP) across hardware platforms
Evaluation of the Systolic and Diastolic Blood Pressure measurement consistency among three devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra) compared to the Masimo Root monitor. The measurement tool is the rPPG software. Consistency will be assessed by calculating the Mean Absolute Error (MAE) of blood pressure. Unit of Measure： mmHg
Time frame
During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).Sponsors and contacts
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Source ClinicalTrials.gov