An observational study in Cholecystitis, Liver Neoplasms and Cholelithiasis, sponsored by Taipei Veterans General Hospital, Taiwan. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Taipei Veterans General Hospital, Taiwan · Observational
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.
Background and Rationale:
Perioperative vital sign monitoring is crucial for patient safety. However, current standard-of-care tools are predominantly contact-based or invasive. These devices can cause discomfort, limit patient mobility, and potentially damage fragile skin. While various non-contact sensing technologies (e.g., radar, thermal imaging) have been researched, high costs and poor adaptability to dynamic clinical settings have limited their routine use. Our team has previously validated a camera-based rPPG algorithm in clinical environments; this study seeks to further evaluate its feasibility within the rigorous conditions of an operating room (OR).
Study Objectives:
To evaluate the accuracy and consistency of a non-contact video monitoring system in measuring heart rate, blood pressure, and SpO2 across different surgical phases (pre-operative, intra-operative, and post-operative).To optimize algorithms using multi-point clinical data to enhance system robustness in dynamic surgical environments. To explore the potential of rPPG technology as a supplementary or alternative monitoring solution for patients unsuitable for traditional contact-based sensors.
Methodology:
This is a feasibility study conducted in a perioperative clinical environment. Participants will undergo simultaneous monitoring by two systems without interference with routine medical care:
Data Analysis:
The estimated physiological parameters from the non-contact software will be compared with the synchronized data from the Masimo Root system. Statistical analysis will focus on the correlation and limits of agreement between the two methods to determine the technical feasibility for future clinical translation.
192 studies on the registry are indexed under Cholecystitis; 36 are open to participants now.
This study's planned enrollment of 315 is above the median of 222 across 55 observational studies indexed under Cholecystitis.
Browse Cholecystitis studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 338 studies on the registry; 74 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Surgical patients undergoing anesthesia and surgery at Taipei Veterans General Hospital who meet the specified inclusion and exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Non-contact rPPG software
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.
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).
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).
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).
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).
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).
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).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Individual participant data will not be shared at this time to protect proprietary algorithmic information and ongoing technical development related to the monitoring software.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
Of 23 observational studies under Cholecystitis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's planned 23 months is below that.
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Taipei Veterans General Hospital, Taiwan →