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NCT01652521 Clinical Trial

Effects of Pleural Effusion Drainage on Respiratory System Mechanics

Pleural Effusion Clinical Trial

Official title:
Effects of Pleural Effusion Drainage on Respiratory System Mechanics in Mechanically Ventilated Patients, as Measured by Esophageal Balloon.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01652521
Other study ID # 0083-12-WOMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 23, 2012
Last updated July 25, 2012
Start date July 2012
Est. completion date July 2013

Study information
Verified date July 2012
Source Wolfson Medical Center
Contact Arie Soroksky, M.D.
Phone 972-50-4056787
Email soroksky@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Description:

Esophageal balloon will be inserted prior to pleural fluid drainage.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Wolfson MC Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Brown NE, Zamel N, Aberman A. Changes in pulmonary mechanics and gas exchange following thoracocentesis. Chest. 1978 Nov;74(5):540-2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary oxygenation 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 No
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