Effects of Pleural Effusion Drainage on Respiratory System Mechanics

• Conditions: Pleural Effusion

• Registration Number: NCT01652521
• Lead Sponsor: 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.

Detailed Description

Esophageal balloon will be inserted prior to pleural fluid drainage.

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-25
• Last Update Submitted: 2012-07-25
• Study First Posted: 2012-07-30
• Last Update Posted: 2012-07-30
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
chest wall and lung compliance	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

Name	Time	Method
oxygenation	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.

Trial Locations

Locations (1)

Wolfson MC; 🇮🇱 Holon, Israel