Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07473687
Acronym
IBPM
Enrollment
315
Registered
2026-03-16
Start date
2026-01-08
Completion date
2030-06-30
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Cholelithiasis, Inguinal Hernia, Liver Neoplasms

Keywords

General anesthesia, Intraoperative monitoring, Camera-based monitor, Non-contact Physiological Monitoring, Total Extraperitoneal Approach (TEP), Remote Sensing, Perioperative Care

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.

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.

Interventions

DEVICENon-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.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Heart Rate (HR) monitoringFrom 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 (%)
Success rate of Systolic Blood Pressure (SBP) monitoringFrom 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 (%)
Success rate of Diastolic Blood Pressure (DBP) monitoringFrom 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 (%)
Success rate of Oxygen Saturation (SpO2) monitoringFrom 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 (%)

Secondary

MeasureTime frameDescription
Mean Absolute Error (MAE) of Heart Rate (HR) across hardware platformsDuring 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)
Mean Absolute Error (MAE) of Blood Pressure (SBP and DBP) across hardware platformsDuring 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

Countries

Taiwan

Contacts

CONTACTHui-Hsuan Ke
kehuihsuan0221@gmail.com+886-939-196-809
PRINCIPAL_INVESTIGATORHui-Hsuan Ke

Taipei Veterans General Hospital, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026