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Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax (EXPRED)

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ClinicalTrials.gov Identifier: NCT01008228
Recruitment Status : Unknown
Verified February 2015 by DESMETTRE, Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2009
Last Update Posted : February 24, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Pneumothorax Procedure: exsufflation Procedure: thoracic tube drainage

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax
Study Start Date : June 2009
Primary Completion Date : March 2014
Estimated Study Completion Date : March 2015

Arms and Interventions

Arm Intervention/treatment
Active Comparator: tube thoracic drainage
drainage performed with tube drainage CH 16 or ch 20
Procedure: thoracic tube drainage
thoracic tube drainage will be performed with a tube Ch 16 or ch 20
Other Names:
  • Monod Trocar
  • Chest Tube
Experimental: exsufflation
exsufflation with a specific thoracentesis system
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
Other Name: Turkel Kit

Outcome Measures

Primary Outcome Measures :
  1. size of residual pneumothorax measured on chest radiography [ Time Frame: one day ]

Secondary Outcome Measures :
  1. size of residual pneumothorax at one week [ Time Frame: one week ]
  2. recidive of pneumothorax at one year [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008228

Centre Hospitalier Intercommunal de la Haute Saône
Vesoul, Franche Comté, France, 70000
CHU Angers
Angers, France, 49100
Hôpital Henri Mondor
Aurillac, France, 15000
Centre Hospitalier
Belfort, France, 90016
CHU Besancon
Besançon, France, 25030
CH Bethune
Bethune, France, 62400
CH Boulogne sur Mer
Boulogne sur Mer, France, 62320
CHU Clermont Ferrand
Clermont Ferrand, France, 63003
CHU Dijon
Dijon, France, 21033
CHU Grenoble
Grenoble, France, 38043
Henin Beaumont, France, 62110
CH Lomme
Lomme, France, 59160
CHU Marseille
Marseille, France, 13385
Chi Le Raincy/Montfermeil
Montfermeil, France, 93370
CH Mulhouse
Mulhouse, France, 68051
CHU Nimes
Nimes, France, 30029
CH Perpignan
Perpignan, France, 66046
CHU Poitiers
Poitiers, France, 86000
CHU Reims
Reims, France, 54035
CHR Roubaix
Roubaix, France, 59100
CH Rouen
Rouen, France, 76000
CHU Saint Etienne
Saint Etienne, France, 42050
CHU Toulouse
Toulouse, France, 31059
CHU Tours
Tours, France, 37040
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire Dijon
Belfort Hospital
Central Hospital, Nancy, France
Norman Bethune Medical Hospital
St Philibert Hospital, Lomme
Hospital of Montfermeil
University Hospital, Brest
University Hospital, Clermont-Ferrand
Nantes University Hospital
Association Hospitalière Nord Artois Cliniques
Poitiers University Hospital
University Hospital, Tours
CHU de Reims
Hospital of Perpignan
Hospices Civils de Lyon
Centre Hospitalier Universitaire de Saint Etienne
Hospital of Roubaix
Hospital of Boulogne/mer
Assistance Publique Hopitaux De Marseille
University Hospital, Rouen
University Hospital, Angers
Centre Hospitalier le Mans
Centre Hospitalier Universitaire de Nīmes
University Hospital, Grenoble
Hospital of Mulhouse
Hospital of Valence
Principal Investigator: Thibaut TJ Desmettre Hospital University of Besancon
Principal Investigator: Thibaut DESMETTRE, MD CHU Besançon