Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax
NCT ID: NCT01008228
Last Updated: 2020-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
402 participants
INTERVENTIONAL
2009-06-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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tube thoracic drainage
drainage performed with tube drainage CH 16 or ch 20
thoracic tube drainage
thoracic tube drainage will be performed with a tube Ch 16 or ch 20
exsufflation
exsufflation with a specific thoracentesis system
exsufflation
exsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Belfort Hospital
OTHER
Central Hospital, Nancy, France
OTHER
Norman Bethune Medical Hospital
OTHER
St Philibert Hospital, Lomme
UNKNOWN
Hospital of Montfermeil
UNKNOWN
University Hospital, Brest
OTHER
University Hospital, Clermont-Ferrand
OTHER
Nantes University Hospital
OTHER
Association Hospitalière Nord Artois Cliniques
OTHER
Poitiers University Hospital
OTHER
University Hospital, Tours
OTHER
CHU de Reims
OTHER
Centre hospitalier de Perpignan
OTHER
Hospices Civils de Lyon
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Hospital of Roubaix
UNKNOWN
Hospital of Boulogne/mer
UNKNOWN
Assistance Publique Hopitaux De Marseille
OTHER
University Hospital, Rouen
OTHER
University Hospital, Angers
OTHER_GOV
Centre Hospitalier le Mans
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
University Hospital, Grenoble
OTHER
Hospital of Mulhouse
UNKNOWN
Hospital of Valence
UNKNOWN
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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DESMETTRE
Dr Thibaut Desmettre, MD, PhD
Principal Investigators
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Thibaut TJ Desmettre
Role: PRINCIPAL_INVESTIGATOR
Hospital University of Besancon
Thibaut DESMETTRE, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Besançon
Locations
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Centre Hospitalier Intercommunal de la Haute Saône
Vesoul, Franche Comté, France
CHU Angers
Angers, , France
Hôpital Henri Mondor
Aurillac, , France
Centre Hospitalier
Belfort, , France
CHU Besancon
Besançon, , France
CH Bethune
Béthune, , 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
Hénin-Beaumont, , France
CH Lomme
Lomme, , France
CHU Marseille
Marseille, , France
Chi Le Raincy/Montfermeil
Montfermeil, , France
CH Mulhouse
Mulhouse, , France
CHU Nimes
Nîmes, , 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
Countries
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References
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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. No abstract available. French.
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.
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. No abstract available. French.
Marx T, Joly LM, Parmentier AL, Pretalli JB, Puyraveau M, Meurice JC, Schmidt J, Tiffet O, Ferretti G, Lauque D, Honnart D, Al Freijat F, Dubart AE, Grandpierre RG, Viallon A, Perdu D, Roy PM, El Cadi T, Bronet N, Duncan G, Cardot G, Lestavel P, Mauny F, Desmettre T. Simple Aspiration versus Drainage for Complete Pneumothorax: A Randomized Noninferiority Trial. Am J Respir Crit Care Med. 2023 Jun 1;207(11):1475-1485. doi: 10.1164/rccm.202110-2409OC.
Other Identifiers
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R/2009/38
Identifier Type: -
Identifier Source: org_study_id
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