exsufflation
Procedureexsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes
Other names: Turkel Kit
NCT Number: NCT01008228
Management of primary spontaneous pneumothorax (PSP) remains unclear. Primary therapeutic goals for PSP include removal of air from the pleural space an prevention of recurrences. The absence of generally accepted and methodologically sound recommendations may account for the extensive variation in practice for air evacuation techniques. Air evacuation may be achieved by simple aspiration (exsufflation) or conventional chest tube drainage. Chest tube thoracotomy remains the most popular technique.Aspiration is a more simple technique, that allows possibility of ambulatory management. The purpose of the present study is to compare simple aspiration performed with a specific thoracentesis device, versus conventional chest tube drainage. Comparison will be performed on immediate efficacity of resolution of the pneumothorax.The hypothesis is that simple aspiration performed with a specific device is not inferior to chest tube drainage for management of a first episode of large size primary spontaneous pneumothorax. A second goal is to measure the efficacy at one week, and the recidive at one year. The trial is randomized, controlled and will include 200 patients for each group. The patients will be enrolled in 29 hospitals in France. Emergency department, thoracic surgery and pulmonary departments of each hospital were primarily contacted for agreement to participate to the study.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Centre Hospitalier Intercommunal de la Haute Saône, Vesoul, Franche Comté, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
exsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes
Other names: Turkel Kit
thoracic tube drainage will be performed with a tube Ch 16 or ch 20
Other names: Monod Trocar, Chest Tube
Time frame: one day
Time frame: one week
Time frame: one year
Centre Hospitalier Universitaire de Besancon
Other
Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax
Acronym: EXPRED
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