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临床试验/NCT01474824
NCT01474824终止不适用

Validation of the Nexfin Non-invasive Cardiac Output Monitor in Patients Undergoing Hip Fracture Repair

University of Nottingham2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus

研究概览

简要总结

Measurement of how much blood the heart pumps may be useful in guiding how much intravenous fluid to give patients during surgery. The current monitors either require special drips (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which may limit their use. Newer monitors are available which are completely non-invasive and seem to work well in younger patients. Patients with hip fracture are elderly and frail. The investigators wish to see whether the newer non-invasive monitor works well enough compared to the current monitors in this group of patients. If it does this may allow more of these patients to be monitored in this way.

详细描述

The investigators wish to compare the accuracy of the newer, non-invasive monitor (Nexfin) against a more established minimally invasive monitor (LiDCO). The LiDCO has a calibration system which allows the absolute accuracy of the Nexfin to be established.

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
80 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged over 80
  • Able to give their own informed consent

排除标准

  • Severe valvular heart disease
  • Taking lithium

结局指标

主要结局

Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus

时间窗: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia

Analysis of agreement between Nexfin cardiac output and the calibrated cardiac output measured by LiDCOplus

次要结局

  • Bias and limits of agreement for change in cardiac output measured by Nexfin compared with LiDCO(During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia)
  • Utility of Nexfin monitor(Intra-operative - average duration about 1 hour)
  • Adverse events associated with Nexfin monitor(Intra-operative - average duration about one hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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