Pneumothorax | Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax
Pneumothorax research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - patients aged more than 18 years and less than 50 years - first episode of pneumothorax - primary pneumothorax (absence of known pulmonary disease) - large size of pneumothorax : presence of a visible rim of air between the lund margin and the chest wall, from the apex to pulmonary base Exclusion Criteria: - impossibility to obtain patient consent for psychiatric disease - patients under justice control - âgé less than 18 years, or more than 50 years - impossibility of medical follow de for geographic, social or psychic reasons - pregnant women - pneumothorax with acute respiratory insufficiency or bad tolerated - recidive of pneumothorax - traumatic pneumothorax - pneumothorax with pleural effusion - bilatéral pneumothorax - pneumothorax with pulmonary disease
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:exsufflationexsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes
Procedure:thoracic tube drainagethoracic tube drainage will be performed with a tube Ch 16 or ch 20
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
tube thoracic drainagedrainage performed with tube drainage CH 16 or ch 20
exsufflationexsufflation with a specific thoracentesis system
Start Date: June 2009
Completed Date: March 2015
Primary Outcome: size of residual pneumothorax measured on chest radiography
Secondary Outcome: size of residual pneumothorax at one week
Study sponsors, principal investigator, and references
Principal Investigator: Thibaut TJ Desmettre
Lead Sponsor: Centre Hospitalier Universitaire de Besancon
Collaborator: Centre Hospitalier Universitaire Dijon
Desmettre T, Meurice JC, Kepka S, Dalphin JC. [Treatment of first spontaneous pneumothorax: drainage or exsufflation?]. Rev Mal Respir. 2011 Jan;28(1):5-8. doi: 10.1016/j.rmr.2010.10.028. Epub 2011 Jan 12. Review. French.