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Effects of Pleural Effusion Drainage on Respiratory System Mechanics

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ClinicalTrials.gov Identifier: NCT01652521
Recruitment Status : Unknown
Verified July 2012 by Soroksky Arie, Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center

Brief Summary:
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 or disease
Pleural Effusion

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

Study Type : Observational
Estimated Enrollment : 20 participants
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.
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Group/Cohort
candidates for pleural fluid drainage
patients who are candidates for pleural fluid drainage.



Primary Outcome Measures :
  1. 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 :
  1. 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.



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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.

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

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 Posted: July 30, 2012    Key Record Dates
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