Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax (EXPRED)
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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 |
- size of residual pneumothorax measured on chest radiography [ Time Frame: one day ] [ Designated as safety issue: Yes ]
- 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:
|
|
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 |
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| Contact: Thibaut TJ DESMETTRE, PH | 38168837 ext 0033 | tdesmettre@chu-besancon.fr |
| 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 | |
| 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 May 19, 2013