Detection of Pleural Effusion by Internal Thoracic Impedance Method
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|ClinicalTrials.gov Identifier: NCT01601444|
Recruitment Status : Unknown
Verified May 2012 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : May 18, 2012
Last Update Posted : May 18, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Device: Pletysmograph||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Pleural Effusion by Internal Thoracic Impedance Method|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||August 2013|
- Device: Pletysmograph
Pletysmograph electrodes are applied to the thoracic wallOther Name: Edema Guard Monitor (EMG) model RS-207 (RS Medical Monitoring Ltd. Jerusalem, Israel
- Internal thoracic impedance [ Time Frame: 12 months ]