Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- validation systole, diastole, mean ABP and pulse pressure
研究概览
简要总结
Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.
This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
详细描述
Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.
After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.
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
- 是
入选标准
- •Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac).
- •Patients older than 18, for elective general surgery.
排除标准
- •Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures
结局指标
主要结局
validation systole, diastole, mean ABP and pulse pressure
时间窗: within 1 hour
accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)
implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure
时间窗: time during surgery
Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve
次要结局
未报告次要终点
研究者
D.P.Veelo
Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)