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Effects of Pleural Effusion Drainage on Respiratory System Mechanics

This study is not yet open for participant recruitment.
Verified July 2012 by Wolfson Medical Center
Sponsor:
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01652521
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • chest wall and lung compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 23, 2012
Last Updated: July 25, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 21, 2013