Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT01008228
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2009-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Study Overview
Official Title:
Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPRED
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: