Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax

Pneumothorax Clinical Trial

— EXPRED  

Official title:

Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008228
• Other study ID #: R/2009/38
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: December 2015

Study information

• Verified date: February 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Procedure:
• exsufflation
exsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes
• thoracic tube drainage
thoracic tube drainage will be performed with a tube Ch 16 or ch 20

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpital Henri Mondor	Aurillac
France	Centre Hospitalier	Belfort
France	CHU Besancon	Besançon
France	CH Bethune	Bethune
France	CH Boulogne sur Mer	Boulogne sur Mer
France	CHU Clermont Ferrand	Clermont Ferrand
France	CHU Dijon	Dijon
France	CHU Grenoble	Grenoble
France	Clinique de HENIN BEAUMONT	Henin Beaumont
France	CH Lomme	Lomme
France	CHU Marseille	Marseille
France	Chi Le Raincy/Montfermeil	Montfermeil
France	CH Mulhouse	Mulhouse
France	CHU Nimes	Nimes
France	CH Perpignan	Perpignan
France	CHU Poitiers	Poitiers
France	CHU Reims	Reims
France	CHR Roubaix	Roubaix
France	CH Rouen	Rouen
France	CHU Saint Etienne	Saint Etienne
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours
France	Centre Hospitalier Intercommunal de la Haute Saône	Vesoul	Franche Comté

Sponsors (27)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire de Besancon

Assistance Publique Hopitaux De Marseille, Association Hospitalière Nord Artois Cliniques, Belfort Hospital, Central Hospital, Nancy, France, Centre Hospitalier le Mans, Centre Hospitalier Universitaire de Nimes, Centre Hospitalier Universitaire de Saint Etienne, Centre Hospitalier Universitaire Dijon, CHU de Reims, Hospices Civils de Lyon, Hospital of Boulogne/mer, Hospital of Montfermeil, Hospital of Mulhouse, Hospital of Perpignan, Hospital of Roubaix, Hospital of Valence, Nantes University Hospital, Norman Bethune Medical Hospital, Poitiers University Hospital, St Philibert Hospital, Lomme, University Hospital, Angers, University Hospital, Brest, University Hospital, Clermont-Ferrand, University Hospital, Grenoble, University Hospital, Rouen, University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

Desmettre T, Meurice JC, Mauny F, Woronoff MC, Tiffet O, Schmidt J, Ferretti G, Dalphin JC. [Comparison of simple aspiration versus standard drainage in the treatment of large primary spontaneous pneumothorax]. Rev Mal Respir. 2011 Mar;28(3):336-43. doi: 10.1016/j.rmr.2010.10.030. Epub 2011 Mar 10. French. — View Citation

Desmettre T, Meurice JC, Tapponnier R, Pretalli JB, Dalphin JC. [The EXPRED study: where are we?]. Rev Mal Respir. 2013 Jan;30(1):18-21. doi: 10.1016/j.rmr.2012.09.019. Epub 2012 Nov 13. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	size of residual pneumothorax measured on chest radiography		one day
Secondary	size of residual pneumothorax at one week		one week
Secondary	recidive of pneumothorax at one year		one year