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Drainage Amount for Removal of Thoracostomy Tube (DARTT)

Primary Purpose

Pneumothorax, Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No drainage threshold
Drainage <2 mL/kg
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring Chest tubes, Trauma

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis, Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

No drainage threshold

Drainage <2 mL/kg

Outcomes

Primary Outcome Measures

Invasive drainage procedure

Secondary Outcome Measures

Time to thoracostomy tube removal
Pulmonary symptoms
Mortality

Full Information

First Posted
December 14, 2007
Last Updated
June 19, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00575198
Brief Title
Drainage Amount for Removal of Thoracostomy Tube
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Pleural Effusion
Keywords
Chest tubes, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
No drainage threshold
Arm Title
2
Arm Type
Active Comparator
Arm Description
Drainage <2 mL/kg
Intervention Type
Other
Intervention Name(s)
No drainage threshold
Intervention Description
Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
Intervention Type
Other
Intervention Name(s)
Drainage <2 mL/kg
Other Intervention Name(s)
Standard thoracostomy tube management
Intervention Description
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 Outcome Measure Information:
Title
Invasive drainage procedure
Time Frame
Within 60 days
Secondary Outcome Measure Information:
Title
Time to thoracostomy tube removal
Time Frame
Within 60 days
Title
Pulmonary symptoms
Time Frame
60 days
Title
Mortality
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garth H Utter, MD MSc
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis, Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Drainage Amount for Removal of Thoracostomy Tube

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