Expired Study
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Sacramento, California 95817


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

200715709


NCT ID:

NCT00575198


Secondary ID:


Study Acronym:

DARTT


Brief Title:

Drainage Amount for Removal of Thoracostomy Tube


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

14 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

280


Enrollment Type:

Actual


Overall Contact Information

Official Name:Garth H Utter, MD MSc
Principal Investigator
University of California, Davis

Study Dates

Start Date:December 2007
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:September 2012
Primary Completion Type:Actual
Verification Date:June 2017
Last Changed Date:June 19, 2017
First Received Date:December 14, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Invasive drainage procedure
Time Frame:Within 60 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to thoracostomy tube removal
Time Frame:Within 60 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pulmonary symptoms
Time Frame:60 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mortality
Time Frame:60 days
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:No drainage threshold
Description:Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours
Arm Name:1
Intervention Type:Other
Name:Drainage <2 mL/kg
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
Arm Name:2
Other Name:Standard thoracostomy tube management

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:No drainage threshold
Study Arm Type:Active Comparator
Arm Name:2
Description:Drainage <2 mL/kg

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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