Wearable Blood-Pressure Monitoring Comparison Study (WBPMCS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Agreement of wearable blood pressure measurement methods with clinical reference measurements
研究概览
简要总结
The goal of this clinical trial is to compare the accuracy, clinical applicability, and usability of different wearable blood pressure monitoring methods integrated in wearable devices, such as smartwatches, in hospitalized patients. The study evaluates novel photoplethysmography (PPG)-based and wrist-oscillometric blood pressure measurement methods against established clinical reference methods (upper-arm cuff measurements on the general ward and invasive arterial blood pressure monitoring (A-line) in the intensive care unit).
The main questions the study aims to answer are:
- Can novel blood pressure monitoring methods suitable for integration into wearable devices achieve clinically acceptable agreement with established reference measurements?
- How does the performance of calibration-dependent wearable devices change over time following calibration?
- How does the performance of the investigated methods compare with each other?
- How do the investigated methods perform for patients with different pre-existing conditions ?
To answer these questions, participants will undergo:
- blood pressure measurements using different wearable devices based on PPG and wrist oscillometry
- standardized reference blood pressure measurements using an upper-arm cuff (general ward) or an existing invasive arterial line (intensive care unit)
- repeated measurements over three consecutive days on the general ward to assess calibration stability and measurement reproducibility,
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Blood pressure measurements can be performed on at least one arm, for example no amputation, dialysis shunt, or obstructive dressing
- •Ability to understand the study information and provide written informed consent
- •For participants in the intensive care unit: an arterial line placed for clinical reasons
排除标准
- •Wrist circumference exceeds the size range of the investigated wearable devices
- •Physical or medical conditions preventing placement of the wearable devices, including relevant skin lesions, wounds, severe edema, or patient restraint
- •Inability to provide written informed consent
研究组 & 干预措施
Cohort at general ward
Cohort at ICU
结局指标
主要结局
Agreement of wearable blood pressure measurement methods with clinical reference measurements
时间窗: General ward: From the calibration day through two days after calibration ICU: During the single study measurement session
The mean difference and standard deviation of the differences in systolic and diastolic blood pressure, expressed in mmHg, between each investigated wearable blood pressure measurement method and the corresponding reference method.
Agreement of wearable blood pressure measurement methods with clinical reference measurements
时间窗: General ward: At each measurement session on study days 1, 2, and 3. ICU: At measurement session on study day 1, approx. 2 hours after device calibration
The mean difference and standard deviation of the differences in systolic and diastolic blood pressure, expressed in mmHg, between each investigated wearable blood pressure measurement method and the corresponding reference method.
次要结局
未报告次要终点
研究者
Moritz Herzog
Principal Investigator
Technische Universität Dresden