Drainage Amount for Removal of Thoracostomy Tube

NCT ID: NCT00575198

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Pneumothorax; Pleural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

No drainage threshold

Group Type: EXPERIMENTAL

No drainage threshold

Intervention Type: OTHER

Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours

2

Drainage \<2 mL/kg

Group Type: ACTIVE_COMPARATOR

Drainage <2 mL/kg

Intervention Type: OTHER

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

Interventions

No drainage threshold

Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Standard thoracostomy tube management

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Garth H Utter, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis, Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

200715709

Identifier Type: -

Identifier Source: org_study_id