Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Amsterdam、荷兰、1105AZ
- 招聘中
- Academic Medical Center
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接触：
- D.P. Veelo, Dr.
- 电话号码：0031205662533
- 邮箱：d.p.veelo@amc.uva.nl
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Cohort
Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform.
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A cuff is placed on a finger of the patient.
The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform.
Note: There will only be observational recordings, no interventions
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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validation systole, diastole, mean ABP and pulse pressure
大体时间：within 1 hour
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accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)
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within 1 hour
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implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure
大体时间：time during surgery
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Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve
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time during surgery
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合作者和调查者
调查人员
- 首席研究员：D.P. Veelo, Dr、inverstigator
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ClearSight feasibility testing的临床试验
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National University Hospital, Singapore招聘中