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Effects of Pleural Effusion Drainage on Respiratory System Mechanics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Soroksky Arie, Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01652521
First Posted: July 30, 2012
Last Update Posted: July 30, 2012
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.
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center
  Purpose
The effects of pleural drainage on lung mechanics are unknown. Insertion of esophageal balloon will allow us to measure and assess pleural pressure, and thus assess any possible effects of pleural fluid drainage may have on lung mechanics.

Condition
Pleural Effusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Pleural Effusion Drainage on Respiratory System Mechanics in Mechanically Ventilated Patients, as Measured by Esophageal Balloon.

Further study details as provided by Soroksky Arie, Wolfson Medical Center:

Primary Outcome Measures:
  • chest wall and lung compliance [ Time Frame: 1 year ]
    The use of esophageal balloon allows us to partition respiratory system into its components, namely, chest wall and lung compliance. These measurements have not been described so far in patients undergoing pleural fluid drainage. Thus, assessment of esophageal pressure which is a surrogate of pleural pressure will allow us an accurate measurement of the effect of pleural fluid drainage on chest wall and lung mechanics.


Secondary Outcome Measures:
  • oxygenation [ Time Frame: 1 year ]
    We suspect that pleural fluid drainage will be associated with improved chest wall and lung mechanics. If this will be the case, then we expect a concomitant improvement in oxygenation.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
candidates for pleural fluid drainage
patients who are candidates for pleural fluid drainage.

Detailed Description:
Esophageal balloon will be inserted prior to pleural fluid drainage.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.
Criteria

Inclusion Criteria:

  • Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.who are candidates for pleural fluid drainage.

Exclusion Criteria:

  • Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652521


Contacts
Contact: Arie Soroksky, M.D. 972-50-4056787 soroksky@gmail.com

Locations
Israel
Wolfson MC Not yet recruiting
Holon, Israel
Principal Investigator: Arie Soroksky, MD         
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Arie Soroksky, MD Wolfson MC
  More Information

Publications:
Responsible Party: Soroksky Arie, M.D., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01652521     History of Changes
Other Study ID Numbers: 0083-12-WOMC
First Submitted: July 23, 2012
First Posted: July 30, 2012
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by Soroksky Arie, Wolfson Medical Center:
lung compliance
pleural effusion
esophageal pressure

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