Drainage Amount for Removal of Thoracostomy Tube

Pleural Effusion Clinical Trial

— DARTT  

Official title:

Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575198
• Other study ID #: 200715709
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: June 19, 2017
• Start date: December 2007
• Est. completion date: December 2012

Study information

• Verified date: June 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion
• Pneumothorax

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of California, Davis, Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive drainage procedure		Within 60 days
Secondary	Time to thoracostomy tube removal		Within 60 days
Secondary	Pulmonary symptoms		60 days
Secondary	Mortality		60 days