A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer: Performance Evaluation in Stability and Blood Pressure Change Tracking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period
研究概览
简要总结
In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP100 start-to-end blood pressure calibration. The invasive arterial catheter (A-line) blood pressure measurement will be used as a reference invasive blood pressure monitor (BPM) equipment. The purpose of the study is to evaluate the stability of the device under evaluation (DUE) and its performance in blood pressure change tracking.
详细描述
- The primary goal (Stability Test): to validate the stability of the repeated measurements of DUE, and the corrected standard deviation of each analysis period shall not exceed 6 mmHg.
- The secondary goal (Blood Pressure Change Tracking): to validate the consistency of DUE vs. the reference BPM equipment in blood pressure change tracking during the change evaluation interval.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be over 22 years old on the date of informed consent.
- •Subject who has undergone radial artery cannulation (A-line) (for medical purposes, specifically for arterial pressure monitoring.
- •Subject or his/her legal representative understand the written informed consent and willing to participate as evidenced by signing the informed consent.
排除标准
- •Patients with an intra-aortic balloon pump
- •Patients with arm or finger injuries
- •Patients who have undergone vascular surgery for upper extremities or contraindications for local treatment upon upper extremities
- •Patients with A-line placement in the brachial artery
- •Participants are considered not suitable for inclusion after evaluation by the researchers (such as poor compliant mental status or health conditions, etc.)
- •Participants or his/her legal representative refuse to sign the informed consent form
结局指标
主要结局
Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period
时间窗: 4 hours
Confirm the consistency of SUT vs. the reference BPM equipment by calculating the blood pressure change during the change evaluation interval
时间窗: 4 hours
次要结局
未报告次要终点