Drainage Amount for Removal of Thoracostomy Tube - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00575198

Purpose

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
Pneumothorax Pleural Effusion	Other: No drainage threshold Other: Drainage <2 mL/kg

U.S. FDA Resources

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

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Invasive drainage procedure [ Time Frame: Within 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to thoracostomy tube removal [ Time Frame: Within 60 days ] [ Designated as safety issue: No ]
Pulmonary symptoms [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Mortality [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

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
1: Experimental No drainage threshold	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
2: Active Comparator Drainage <2 mL/kg	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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Thoracostomy tube in place for <72 hours
Age at least 18 years
Hospitalized for traumatic injury

Exclusion Criteria:

More than one thoracostomy tube in the pleural cavity of interest during the hospitalization
Mediastinal tubes
Death expected within 48 hours
Prisoner status
Severe congestive heart failure
End-stage liver disease
End-stage renal disease
History of or suspected empyema involving the pleural cavity of interest
History of or anticipated need for pleurodesis of the pleural cavity of interest
Malignant pleural effusion
Pregnancy
Previous participation in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575198

Contacts

Contact: Garth H Utter, MD MSc

916-734-1768

garth.utter@ucdmc.ucdavis.edu

Locations

United States, California
University of California, Davis, Medical Center	Recruiting
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Garth H Utter, MD MSc

University of California, Davis

More Information

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

Keywords provided by University of California, Davis:

Chest tubes
Trauma

Study placed in the following topic categories:

Pleural Effusion
Respiratory Tract Diseases
Pleural Diseases
Wounds and Injuries
Pneumothorax

ClinicalTrials.gov processed this record on January 16, 2009