The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.

Study Overview
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Brief Summary
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The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion

Detailed Description
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Determining and timing of chest tube removal has been a continuous topic of debate amongst both surgeons and pulmonologist. It is plausible that provocative clamping tests are no longer necessary when a digital continuous recording drainage device is used that demonstrates the absence of (intermittent) air leak. However, clamping trials are still performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent pneumothorax and no comparative studies exist. We hypothesize that chest tube removal exclusively based on digital drainage system data is as safe as adding a clamping test before removal in patients treated for pneumothorax or after lung surgery. The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.

Official Title
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The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.

Conditions
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Pneumothorax and Air Leak

Intervention / Treatment
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* Other: Digital drainage system
* Other: Digital drainage system + clamping trial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Digital chest tube drainage system Pneumothorax (primary, secondary, pulmonary surgery) Exclusion Criteria: Pleural effusion as primary indication for chest tube placement. Empyema Suspected chest tube malfunction (e.g., leaking, occlusion, malposition) Intubated during chest tube removal

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Digital drainage system group<br>chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. | Other: Digital drainage system<br>* In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data, the tube will not be clamped.<br>|
| Other: Digital drainage system + clamping trial group<br>In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. | Other: Digital drainage system + clamping trial<br>* In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent pneumothorax after chest tube removal | number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax | 0-24 hours after drain removal |