- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01652521
Effects of Pleural Effusion Drainage on Respiratory System Mechanics
July 25, 2012 updated by: Soroksky Arie, Wolfson Medical Center
Effects of Pleural Effusion Drainage on Respiratory System Mechanics in Mechanically Ventilated Patients, as Measured by Esophageal Balloon.
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
Esophageal balloon will be inserted prior to pleural fluid drainage.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arie Soroksky, M.D.
- Phone Number: 972-50-4056787
- Email: soroksky@gmail.com
Study Locations
-
-
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Holon, Israel
- Wolfson MC
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Principal Investigator:
- Arie Soroksky, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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candidates for pleural fluid drainage
patients who are candidates for pleural fluid drainage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arie Soroksky, MD, Wolfson MC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
July 1, 2013
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
July 23, 2012
First Submitted That Met QC Criteria
July 25, 2012
First Posted (Estimate)
July 30, 2012
Study Record Updates
Last Update Posted (Estimate)
July 30, 2012
Last Update Submitted That Met QC Criteria
July 25, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0083-12-WOMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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