Not Invasive Monitoring of Pleural Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
non invasive sensor pleural drainage
feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor in Ohm before and after pleura drainage, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume before and after pleura drainage. Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.
干预措施: Body Bioimpedance Sensor (Device)
non invasive sensor healthy control
the same measurements as in arm 1: feasibility data will be collected with thorax impedance measurements via body bioimpedance sensor before and after pleura drainage in Ohm, via impedance cardiography stroke volume and cardiac output will be calculated and also respiratory parameters determined via capnograph as carbon dioxide (CO2) in %/ml exhaled volume once in 25 healthy controls.
Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.
干预措施: Body Bioimpedance Sensor (Device)
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)