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临床试验/NCT01778270
NCT01778270已完成不适用

Not Invasive Monitoring of Pleural Drainage

RWTH Aachen University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Change of thorax impedance (Ohm)

研究概览

简要总结

This study investigates if data about monitoring the drainage of pleural effusion can be collected by non invasive sensors (feasibility).

详细描述

25 patients > 18 years old with pleura effusion will be examined with regard to the feasibility of non invasive sensor measurements corresponding to the course of thorax impedance and respiration parameters during body fluids loss before and after pleural drainage. The measured data will be compared to standard routine reference measurements (heart rate, medication, brain natriuretic peptide (BNP), heart minute volume). Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.

Also 25 healthy controls will undergo the same measurements to receive standard values.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with pleural effusion undergoing pleural drainage
  • male and female patients aged at least 18 years

排除标准

  • pregnancy or breast feeding
  • implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / Implanted Cardioverter Defibrillator (ICD) except Medtronic Device "OptiVol".
  • patients not being able to consent

结局指标

主要结局

Change of thorax impedance (Ohm)

时间窗: once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour.

non invasive bioimpedance measurements to determine feasibility of body fluid loss before and after pleura drainage in 25 patients \> 18 years old; also 25 healthy controls are measured to receive standard values

次要结局

  • Change of Cardiac output ( l/min) via impedance cardiography(once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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