Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Accuracy of Heart Rate (HR) monitoring
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years.
- •Patients scheduled to undergo surgical procedures under general anesthesia.
- •American Society of Anesthesiologists (ASA) Physical Status I, II, or III.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Non-contact rPPG software (Device)
结局指标
主要结局
Accuracy of Heart Rate (HR) monitoring
时间窗: 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 (%)
Success rate of Systolic Blood Pressure (SBP) monitoring
时间窗: 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 (%)
Success rate of Diastolic Blood Pressure (DBP) monitoring
时间窗: 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 (%)
Success rate of Oxygen Saturation (SpO2) monitoring
时间窗: 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 (%)
次要结局
- 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).)