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Completed

NCT Number: NCT00575198

Drainage Amount for Removal of Thoracostomy Tube

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No drainage threshold

Other

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

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

Other names: Standard thoracostomy tube management

Primary outcomes

  1. Invasive drainage procedure

    Time frame: Within 60 days

Secondary outcomes

  1. Time to thoracostomy tube removal

    Time frame: Within 60 days

  2. Pulmonary symptoms

    Time frame: 60 days

  3. Mortality

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Acronym: DARTT

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 18, 2007
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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