Overview

This trial is active, not recruiting.

Conditions pneumothorax, pleural effusion
Treatments no drainage threshold, drainage <2 ml/kg
Sponsor University of California, Davis
Start date December 2007
End date September 2012
Trial size 280 participants
Trial identifier NCT00575198, UCDIRB-200715709

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
No drainage threshold
no drainage threshold
Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
(Active Comparator)
Drainage <2 mL/kg
drainage <2 ml/kg Standard thoracostomy tube management
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

Primary Outcomes

Measure
Invasive drainage procedure
time frame: Within 60 days

Secondary Outcomes

Measure
Time to thoracostomy tube removal
time frame: Within 60 days
Pulmonary symptoms
time frame: 60 days
Mortality
time frame: 60 days

Eligibility Criteria

Male or female participants at least 14 years old.

Inclusion Criteria: - Thoracostomy tube in place for <72 hours - Age at least 14 years - Hospitalized for traumatic injury or elective operation Exclusion Criteria: - Thoracostomy tube already removed from the pleural cavity of interest - 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 - Thoracostomy tube drainage already <2 mL/kg

Additional Information

Official title Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low
Principal investigator Garth H Utter, MD MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of California, Davis.