Clinical Validation Study of BP BAND: A continuous, cuffless blood pressure monitoring device
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Imedrix Systems Pvt Ltd
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Bland-Altman plot analysis will determine the Limits of Agreement (LoA) and their confidence intervals (CI). Agreement is concluded if the confidence intervals lie within the predefined boundary of ±7 mmHg.
概览
简要总结
This study aims to check the accuracy and reliability of the photoplethysmography (PPG) based cuffless blood pressure (BP) monitoring band in comparison to the gold standard mercury sphygmomanometer across a spectrum of BP readings, ranging from normotensive to hypertensive levels.
The proposed study design is an observational descriptive study to validate the cuffless BP monitoring device against the gold standard Mercury Sphygmomanometer. The study will be coordinated from the Centre for Chronic Disease Control in New Delhi and conducted at the Narayana Institute of Cardiovascular Sciences in Bangalore. The study population will comprise 360 participants aged between 21 and 65 years, with blood pressure levels ranging from normal to pre-hypertension, and stage I and stage II hypertension, ensuring equal representation across these categories. The procedure involves training 2 observers who will measure BP in a static position in a controlled environment. Follow-up tests will be conducted after 2 days not exceeding 28 days. During these tests, measurements will be obtained using both the BP Band and Mercury Sphygmomanometer, which will be used as a reference.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with normal BP, prehypertension, stage 1 hypertension, and stage 2 hypertension.
- •Participants who provide voluntary informed consent to participate in the study.
排除标准
- •Pregnant women, paediatric, or elderly individuals above the age of
- •Participants with present arrhythmias.
结局指标
主要结局
Bland-Altman plot analysis will determine the Limits of Agreement (LoA) and their confidence intervals (CI). Agreement is concluded if the confidence intervals lie within the predefined boundary of ±7 mmHg.
时间窗: Measured at baseline and again within 4 weeks
次要结局
- Mean differences in systolic & diastolic BP over repeated measurements using Bland-Altman analysis.(Measured at baseline & again within 4 weeks)
- Accuracy of BP Band in distinguishing BP ranges (normal, prehypertension, stage 1 & 2 hypertension).(Measured at baseline & again within 4 weeks)
- Participant adherence rates & feedback on usability through structured surveys.(Measured at baseline & again within 4 weeks)
研究者
Dr Arun P Jose
Centre for Chronic Disease Control (CCDC)