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Sponsored by: |
University of California, Davis |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00575198 |
The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube.
Condition | Intervention |
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Pneumothorax Pleural Effusion |
Other: No drainage threshold Other: Drainage <2 mL/kg |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Non-Inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low |
Estimated Enrollment: | 232 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
No drainage threshold
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Other: No drainage threshold
Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
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2: Active Comparator
Drainage <2 mL/kg
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Other: Drainage <2 mL/kg
Removal of the thoracostomy tube only if the drainage from the tube in the prior 24 hours is less than 2 mL/kg of the patient's ideal body weight
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Thoracostomy tubes are routinely used to drain the pleural space of fluid and gas to optimize pulmonary mechanics. Clinicians frequently postpone removal of thoracostomy tubes if the drainage from the tube exceeds a specific volume threshold for the prior 24 hours. However, there is substantial variability in the drainage volume threshold that different clinicians use, and no threshold has been established as clearly superior to any other. Removing tubes independently of the drainage volume may result in a greater risk of pleural effusion or pneumothorax requiring an invasive drainage procedure. However, removing tubes independently of the drainage volume might also expedite recovery by allowing earlier removal of the tube, thus diminishing pain and increasing patient mobility.
Thoracostomy tube management practices, including the drainage volume threshold used, may be dissimilar for different types of disease processes, so this study will be restricted to patients who required a thoracostomy tube for treatment of traumatic injury.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Garth H Utter, MD MSc | 916-734-1768 | garth.utter@ucdmc.ucdavis.edu |
United States, California | |
University of California, Davis, Medical Center | Recruiting |
Sacramento, California, United States, 95817 |
Principal Investigator: | Garth H Utter, MD MSc | University of California, Davis |
Responsible Party: | University of California, Davis ( Garth Utter, MD MSc ) |
Study ID Numbers: | UCDIRB-200715709 |
Study First Received: | December 14, 2007 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00575198 |
Health Authority: | United States: Institutional Review Board |
Chest tubes Trauma |
Pleural Effusion Respiratory Tract Diseases Pleural Diseases Wounds and Injuries Pneumothorax |