Drainage Amount for Removal of Thoracostomy Tube

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumothorax, Pleural Effusion

Intervention / Treatment
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* Other: No drainage threshold
* Other: Drainage <2 mL/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>No drainage threshold | Other: No drainage threshold<br>* Removal of the thoracostomy tube independently of the amount of fluid that drained from the tube in the prior 24 hours<br>|
| Active Comparator: 2<br>Drainage <2 mL/kg | Other: Drainage <2 mL/kg<br>* 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<br>* Other names: Standard thoracostomy tube management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive drainage procedure |  | Within 60 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest tubes, Trauma