Clinical Trial: Detection of Pleural Effusion by Internal Thoracic Impedance Method
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Detection of Pleural Effusion by Internal Thoracic Impedance Method
Brief Summary:
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
Detailed Summary:
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.
Sponsor: Michal Roll PhD,MBA
Current Primary Outcome: Internal thoracic impedance [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Tel-Aviv Sourasky Medical Center
Dates:
Date Received: April 30, 2012
Date Started: June 2012
Date Completion: August 2013
Last Updated: May 16, 2012
Last Verified: May 2012
