Drainage Amount for Removal of Thoracostomy Tube (DARTT)

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax; Pleural Effusion
• Intervention / Treatment: Other: No drainage threshold; Other: Drainage <2 mL/kg

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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
Active Comparator: 2; 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; Other Names: Standard thoracostomy tube management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Invasive drainage procedure	Within 60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	60 days
Time to thoracostomy tube removal	Within 60 days
Pulmonary symptoms	60 days

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Garth H Utter, MD MSc, University of California, Davis

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 14, 2007
• First Submitted That Met QC Criteria: December 14, 2007
• First Posted (Estimate): December 18, 2007

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Trauma; Chest tubes
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax; Pleural Effusion
• Other Study ID Numbers: 200715709