Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study - IMPACT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement
研究概览
简要总结
The aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist.
详细描述
Given the prevalence of hypertension in society and the current limitations associated with oscillometric cuffs, the need for a continuous cuffless alternative for blood pressure home monitoring at a global scale is paramount. Such a device would not only improve the global control of blood pressure, but more generally, it could have a larger social impact by improving the comfort and reducing the stress for the clinical management of hypertensive patients.
In the present study the investigators seek to investigate, as a primary purpose, to evaluate the accuracy of non-invasive blood pressure measurements via a watch-like optical sensor and compare these to standard monitoring (arterial line).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Scheduled for cardiac or vascular surgery, with presence of a radial arterial line for perioperative management;
- •Willing and able to provide Informed Consent.
排除标准
- •(Chronic) pace-maker/ defibrillator in situ at study inclusion;
- •Known severe aortic stenosis (mean gradient > 40 mmHg, valve area < 1 cm2);
- •Rhythmogenic heart disease (resting heart rate > 120/min) at time of study inclusion;
- •Emergency patient (i.e. unscheduled OR).
结局指标
主要结局
Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement
时间窗: 24 hours
Statistical comparison of both measures of diastolic blood pressure
次要结局
- Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach(24 hours)
- Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment)(24 hours)