跳至主要内容
临床试验/NCT02197858
NCT02197858已完成不适用

Clinical Comparison of Hemodynamic Parameters Using Invasive Versus Non-invasive Continuous Blood-pressure Technology During a Total Intravenous Anaesthesia (TIVA).

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Mean arterial pressure

研究概览

简要总结

During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called "extended hemodynamic monitoring" depending on the operation and patient. Frequently an invasive arterial cannula is used to provide continuous information on the blood pressure. This invasive method is very accurate and clinically established, but can be linked to adverse effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a non-invasive manner. It thus offers beat-to-beat information even about the extended hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform EV1000 (Edwards Lifescience).

Assuming that the two methods are equal we plan to measure extended hemodynamic parameters before, during induction and during ongoing anesthesia both invasive and non-invasive. Data will be recorded every 30sec.

Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters is to our knowledge rare and further assessment in this field is needed to offer patients a potentially equally reliable but less invasive monitoring. Furthermore the study should model the effect of remifentanil, propofol or its combination on haemodynamics .

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • elective surgery with the necessity of an arterial catheter

排除标准

  • patient not consented
  • peripheral vascular disease

结局指标

主要结局

Mean arterial pressure

时间窗: during anesthesia induction

次要结局

  • Stroke volume variation(during anaesthesia induction)
  • Stroke volume(during anesthesia induction)
  • Heart rate(during anaesthesia induction)
  • Cardiac output(during anesthesia induction)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tino Münster

Prof. Dr.

University of Erlangen-Nürnberg Medical School

研究点 (1)

Loading locations...

相似试验

Comparability of Invasive and Non-invasive... | 临床试验