Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology

Study Overview
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Brief Summary
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Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping. The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.

Detailed Description
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Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal). Incidence of 24hour pneumothorax after chest tube removal will be recorded.

Official Title
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Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases

Conditions
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Pneumothorax, Chest Tube, Pleural Diseases

Intervention / Treatment
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* Procedure: Clamping
* Procedure: Non Clampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 16 years and more. Patients hospitalized in the National Institute of Respiratory Diseases. Patients who had a chest tube placement during their stay at the hospital, by any cause. Exclusion Criteria: Patients who refuse to sign the informed consent and who refuse to participate in the study. Patients who die before randomization. Patients who gets chest tube removal before being randomized.

Ages Eligible for Study
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Minimum Age: 16 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: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with clamping of the chest tube<br>Patients with 6hour clamping prior to removal | Procedure: Clamping<br>* There will be a randomized selection of patients who will have a clamping of the chest tube 6 hours prior to chest tube removal.<br>|
| Sham Comparator: Patients without clamping of the chest tube<br>Patients will have chest tube removed immediately | Procedure: Non Clampling<br>* There will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pneumothorax after chest tube removal with chest tube clamping | Cases of pneumothorax after chest tube removal despite clamping | After 24 hours of procedure | 
| Incidence of pneumothorax after chest tube removal without chest tube clamping | Cases of pneumothorax after chest tube removal despite clamping | After 24 hours of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital days of stay | Hospital days of stay | Through study completion, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest tube, Pneumothorax, Pleural Diseases