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

This study is currently recruiting participants.
Verified February 2013 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Dijon
Hospital of Belfort
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
AHNAC - Hénin Beaumont
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
AHNAC - Divion
Hospital of Boulogne/mer
AHNAC - Liévin
Assistance Publique Hopitaux De Marseille
University Hospital, Rouen
University Hospital, Angers
University Hospital, Le Mans
Centre Hospitalier Universitaire de Nīmes
University Hospital, Grenoble
Hospital of Mulhouse
Hospital of Valence
Information provided by (Responsible Party):
DESMETTRE, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01008228
First received: September 9, 2009
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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 Intervention
Pneumothorax
Procedure: exsufflation
Procedure: thoracic tube drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • size of residual pneumothorax measured on chest radiography [ Time Frame: one day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • size of residual pneumothorax at one week [ Time Frame: one week ] [ Designated as safety issue: Yes ]
  • recidive of pneumothorax at one year [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: June 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008228

Contacts
Contact: Thibaut TJ DESMETTRE, PH 38168837 ext 0033 tdesmettre@chu-besancon.fr

Locations
France
Centre Hospitalier Intercommunal de la Haute Saône Recruiting
Vesoul, Franche Comté, France, 70000
Contact: Toufiq El Cadi, MD    03 84 96 60 31    t.elcadi@chi70.fr   
Contact: Laure Piller, MD    03 84 96 60 31    laurette.piller@free.fr   
Principal Investigator: Toufiq El Cadi, MD         
CHU Angers Recruiting
Angers, France, 49100
Contact: Betty Mazet, MD    02.41.35.79.47    BeMazet@chu-angers.fr   
Sub-Investigator: Thierry Urban, MD         
Hôpital Henri Mondor Recruiting
Aurillac, France, 15000
Contact: Jean-Marc Philippe, MD       jm.philippe@ch-aurillac.fr   
Sub-Investigator: Ali El Hassani, MD         
Centre Hospitalier Recruiting
Belfort, France, 90016
Contact: Jean-Bernard BRAUN, MD    03.84.98.50.02    jbbraun@chbm.fr   
Sub-Investigator: ALFREIJAT, MD         
CHU Besancon Recruiting
Besançon, France, 25030
Contact: Thibaut DESMETTRE, MD    03.81.66.88.37    tdesmettre@chu-besancon.fr   
Sub-Investigator: Jean-Charles DALPHIN, MD         
CH Bethune Recruiting
Bethune, France, 62400
Contact: Frédéric Bart, MD    03.21.64.43.36    fbart@ch-bethune.fr   
Sub-Investigator: Alain-Eric Dubart, MD         
CH Boulogne sur Mer Recruiting
Boulogne sur Mer, France, 62320
Contact: Gilles Cardot, MD    03.21.99.30.22    gilcar@worldonline.fr   
Sub-Investigator: Grégory Duncan, MD         
CHU Clermont Ferrand Recruiting
Clermont Ferrand, France, 63003
Contact: Christophe Perrier, MD    04.73.75.19.99    cperrier@chu-clermontferrand.fr   
Sub-Investigator: Jeannot Schmidt, MD         
CHU Dijon Recruiting
Dijon, France, 21033
Contact: Honnart, MD    03.80.29.53.04    catherine.thibaut@chu-dijon.fr   
Sub-Investigator: Nicolas Cheynel, MD         
Polyclinique de DIVION Withdrawn
Divion, France, 62460
CHU Grenoble Recruiting
Grenoble, France, 38043
Contact: Françoise Carpentier, MD    04.76.76.59.31    Fcarpentier@chu-grenoble.fr   
Sub-Investigator: Pr Pison, MD         
Clinique de HENIN BEAUMONT Recruiting
Henin Beaumont, France, 62110
Contact: Philippe Lestavel, MD    03.21.13.30.32    plestavel@ahnac.com   
Sub-Investigator: Eric Fournier, MD         
CH Lomme Recruiting
Lomme, France, 59160
Contact: Nathalie Bronet, MD    03.20.00.56.22    bronet.nathalie@ghicl.net   
Sub-Investigator: Françoise Roy Saint-Georges, MD         
CHU Marseille Terminated
Marseille, France, 13385
Chi Le Raincy/Montfermeil Recruiting
Montfermeil, France, 93370
Contact: Maurice Raphael, MD    01.41.70.82.79    mraphael@ch-montfermeil.fr   
Sub-Investigator: Emmanuelle Zamparini, MD         
CH Mulhouse Recruiting
Mulhouse, France, 68051
Contact: Bruno Goulesque, MD    03.89.64.61.49    goulesqueb@ch-mulhouse.fr   
Sub-Investigator: Odile Sizaret, MD         
CHU Nimes Recruiting
Nimes, France, 30029
Contact: Patrick Richard, MD    04.66.68.30.50    patrick.richard@chu-nimes.fr   
Sub-Investigator: Eric Picard, MD         
CH Perpignan Recruiting
Perpignan, France, 66046
Contact: Guy André Pelouze, MD    04.68.61.64.21    guyandrepelouze@gmail.com   
Sub-Investigator: Jean-Luc Barone, MD         
CHU Poitiers Recruiting
Poitiers, France, 86000
Contact: Jean-Claude Meurice, MD    05.49.44.44.74    meurice@chu-poitiers.fr   
Sub-Investigator: Jean Rouffineau, MD         
CHU Reims Recruiting
Reims, France, 54035
Contact: Xavier Schwartz, MD    03.26.78.76.03    xschwartz@chu-reims.fr   
Sub-Investigator: Xavier Schwartz, MD         
CHR Roubaix Recruiting
Roubaix, France, 59100
Contact: François Steenhouwer, MD    03.20.99.31.74    francois.steenhouwer@ch-roubaix.fr   
Sub-Investigator: Marie-anne Babe, MD         
CH Rouen Recruiting
Rouen, France, 76000
Contact: Luc-Marie Joly, MD    02.32.88.68.59    Luc-Marie.Joly@chu-rouen.fr   
Sub-Investigator: Jean Melki, MD         
CHU Saint Etienne Recruiting
Saint Etienne, France, 42050
Contact: Olivier Tiffet, MD    04.77.82.83.37    olivier.tiffet@chu-st-etienne.fr   
Sub-Investigator: Alain Viallon, MD         
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Dominique Lauque, MD       lauque.d@chu-toulouse.fr   
Sub-Investigator: Dr Pontier, MD         
CHU Tours Recruiting
Tours, France, 37040
Contact: Régis Lanotte, MD    02.47.47.81.09    r.lanotte@chu-tours.fr   
Sub-Investigator: Pascal Dumont, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire Dijon
Hospital of Belfort
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
AHNAC - Hénin Beaumont
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
AHNAC - Divion
Hospital of Boulogne/mer
AHNAC - Liévin
Assistance Publique Hopitaux De Marseille
University Hospital, Rouen
University Hospital, Angers
University Hospital, Le Mans
Centre Hospitalier Universitaire de Nīmes
University Hospital, Grenoble
Hospital of Mulhouse
Hospital of Valence
Investigators
Principal Investigator: Thibaut TJ Desmettre Hospital University of Besancon
Principal Investigator: Thibaut DESMETTRE, MD CHU Besançon
  More Information

Additional Information:
Publications:
Responsible Party: DESMETTRE, Dr Thibaut Desmettre, MD, PhD, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01008228     History of Changes
Other Study ID Numbers: R/2009/38
Study First Received: September 9, 2009
Last Updated: February 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Besancon:
spontaneous
primary
first episode

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014