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临床试验/NCT01601444
NCT01601444Unknown不适用

Detection of Pleural Effusion by Internal Thoracic Impedance Method

Michal Roll PhD,MBA0 个研究点目标入组 100 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Internal thoracic impedance

研究概览

简要总结

Early detection of pleural effusion (PLE) would improve the treatment. However, preclinical detection of pleural effusion is often not possible.

Radiographic examination, widely used for detecting pleural effusion ,is not suitable for prolonged monitoring of patients at high risk of developing PLE especially ambulatory or at home The currently available methods for monitoring and early detection such as the measurement of pulmonary capillary wedge pressure or measurement by double indicator thermodilution, are not reliable enough and may themselves lead to complications.

Measuring internal thoracic impedance (ITI), the main component of which is lung impedance, is a noninvasive and safe method. PLE will be diagnosed in accordance with well-accepted clinical signs(dyspnea, cyanosis, pulmonary rales, crepitations, arterial hypoxemia) and roentgenological criteria

详细描述

Early detection of pleural effusion (PLE) would improve the treatment. However, preclinical detection of pleural effusion is often not possible.

Radiographic examination, widely used for detecting pleural effusion ,is not suitable for prolonged monitoring of patients at high risk of developing PLE especially ambulatory or at home (1-9).

The currently available methods for monitoring and early detection such as the measurement of pulmonary capillary wedge pressure or measurement by double indicator thermodilution, are not reliable enough and may themselves lead to complications(2-8).

Yu C-M et al.(9) recently reported successful prediction of CPE by a surgically implanted impedance plethysmograph integrated into a pacemaker . The system was shown to be sufficiently sensitive for cardiogenic pulmonary edema preceding. However this method is invasive and not suitable for wide use (9).

Therefore, these methods are seldom employed for the detection of PLE (3-7). Thus, a safe and accurate technique for early detection and monitoring of PlEf would be of great clinical value. The changes in the blood and extravascular fluid content in the lungs in humans and animals can be easily monitored using a noninvasive and totally safe procedure based on impedance plethysmography (5-12-). This method is based on the fact that the impedance of the lungs decreases with the increase in the fluid and free ions content in them (8,13,). However, it proved to be unsuitable for preclinical stage monitoring of PLE (2-8) for several reasons, mainly the low sensitivity of the existing impedance plethysmographs. This is due to the high skin-electrode contact resistance (13,14), which is of an order of magnitude high erthan the impedance of the lung.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Inclusion criteria for study group will be as follows: patients 40-90 year old with pleural effusion on chest X-ray of different etiologies:
  • coronary heart disease-(CHD)
  • valvular heart disease
  • renal failure
  • infectious disease malignant diseases( all complicated by pleural effusion).
  • The control group will be comprised of patients 40-90years old without pleural effusion established by chest X-ray.

排除标准

  • The exclusion criteria will be respiratory failure due to diseases, wearing a pacemaker,thoracic deformation, pulmonary edema and embolism

结局指标

主要结局

Internal thoracic impedance

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Michal Roll PhD,MBA
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Michal Roll PhD,MBA

Director, Research and Development

Tel-Aviv Sourasky Medical Center

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