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Detection of Pleural Effusion by Internal Thoracic Impedance Method

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

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

Condition or disease Intervention/treatment Phase
Pleural Effusion Device: Pletysmograph Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Intervention Details:
  • Device: Pletysmograph
    Pletysmograph electrodes are applied to the thoracic wall
    Other Name: Edema Guard Monitor (EMG) model RS-207 (RS Medical Monitoring Ltd. Jerusalem, Israel

Primary Outcome Measures :
  1. Internal thoracic impedance [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michal Roll PhD,MBA, Director, Research and Development, Tel-Aviv Sourasky Medical Center Identifier: NCT01601444    
Other Study ID Numbers: TASMC-11-CG-504-CTIL
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012
Keywords provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:
To assess pleural effusion by measuring internal thoracic impedance
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases