Detection of Pleural Effusion by Internal Thoracic Impedance Method

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01601444
First received: April 30, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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 Intervention
Pleural Effusion
Device: Pletysmograph

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection of Pleural Effusion by Internal Thoracic Impedance Method

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Internal thoracic impedance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, Director, Research and Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01601444     History of Changes
Other Study ID Numbers: TASMC-11-CG-504-CTIL
Study First Received: April 30, 2012
Last Updated: May 16, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
To assess pleural effusion by measuring internal thoracic impedance

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014