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
Information provided by (Responsible Party):
Soroksky Arie, Wolfson Medical Center
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Effects of Pleural Effusion Drainage on Respiratory System Mechanics in Mechanically Ventilated Patients, as Measured by Esophageal Balloon.
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:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
candidates for pleural fluid drainage
patients who are candidates for pleural fluid drainage.
Esophageal balloon will be inserted prior to pleural fluid drainage.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.
- Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.who are candidates for pleural fluid drainage.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652521
|Holon, Israel |
|Principal Investigator: Arie Soroksky, MD |
Wolfson Medical Center
||Arie Soroksky, MD
||Soroksky Arie, M.D., Wolfson Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 23, 2012
||July 25, 2012
||Israel: Ministry of Health
Keywords provided by Wolfson Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Respiratory Tract Diseases