Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room (IBPM)

March 10, 2026 updated by: Taipei Veterans General Hospital, Taiwan
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Investigational Device (Non-contact): A software module utilizing rPPG technology installed on multiple platforms (Logitech C930 with Windows Laptop, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra). These devices capture facial video via front-facing cameras to calculate physiological parameters non-invasively.
  2. Reference Standard (Clinical Monitors): The Masimo Root monitoring platform, equipped with SedLine O3 regional oximetry and Radical-7 pulse oximetry, will provide the benchmark physiological data.

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.

Study Type

Observational

Enrollment (Estimated)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Recruiting
        • Department of Anesthesiology, Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Surgical patients undergoing anesthesia and surgery at Taipei Veterans General Hospital who meet the specified inclusion and exclusion criteria.

Description

Inclusion Criteria:

  1. Patients aged >18 years.
  2. Patients scheduled to undergo surgical procedures under general anesthesia.
  3. American Society of Anesthesiologists (ASA) Physical Status I, II, or III.

Exclusion Criteria:

  1. Patients aged < 18 years.
  2. Pregnant patients.
  3. Patients whose facial images cannot be captured or recognized (e.g., due to surgical drapes, severe edema, or major trauma).
  4. Patients who refuse to participate or have not signed the informed consent form.
  5. Other cases deemed unsuitable for the study by the clinical physician or anesthesiologist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Heart Rate (HR) monitoring
Time Frame: From anesthesia induction to recovery (approximately 2-6 hours).

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
Time Frame: From anesthesia induction to recovery (approximately 2-6 hours).

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
Time Frame: From anesthesia induction to recovery (approximately 2-6 hours).

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
Time Frame: From anesthesia induction to recovery (approximately 2-6 hours).

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Absolute Error (MAE) of Heart Rate (HR) across hardware platforms
Time Frame: During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).

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)
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
Time Frame: During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).

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
During the intraoperative phase (duration of the surgical procedure, approximately 2-6 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Hui-Hsuan Ke, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-07-019CC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will not be shared at this time to protect proprietary algorithmic information and ongoing technical development related to the monitoring software.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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