Effects of Pleural Effusion Drainage on Respiratory System Mechanics
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 23, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 30, 2012
July 1, 2012
1 year
July 23, 2012
July 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
chest wall and lung compliance
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.
1 year
Secondary Outcomes (1)
oxygenation
1 year
Study Arms (1)
candidates for pleural fluid drainage
patients who are candidates for pleural fluid drainage.
Eligibility Criteria
Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.
You may qualify if:
- Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.who are candidates for pleural fluid drainage.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wolfson MC
Holon, Israel
Related Publications (1)
Brown NE, Zamel N, Aberman A. Changes in pulmonary mechanics and gas exchange following thoracocentesis. Chest. 1978 Nov;74(5):540-2. doi: 10.1378/chest.74.5.540.
PMID: 738092BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arie Soroksky, MD
Wolfson MC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
July 23, 2012
First Posted
July 30, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 30, 2012
Record last verified: 2012-07