Clinical trial NCT01008228: Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax
Official title: Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Keywords: spontaneous
primary
first episode
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: Belfort Hospital
name: Central Hospital, Nancy, France
name: Norman Bethune Medical Hospital
name: St Philibert Hospital, Lomme
name: Hospital of Montfermeil
name: University Hospital, Brest
name: University Hospital, Clermont-Ferrand
name: Nantes University Hospital
name: Association Hospitalière Nord Artois Cliniques
name: Poitiers University Hospital
name: University Hospital, Tours
name: CHU de Reims
name: Centre hospitalier de Perpignan
name: Hospices Civils de Lyon
name: Centre Hospitalier Universitaire de Saint Etienne
name: Hospital of Roubaix
name: Hospital of Boulogne/mer
name: Assistance Publique Hopitaux De Marseille
name: University Hospital, Rouen
name: University Hospital, Angers
name: Centre Hospitalier le Mans
name: Centre Hospitalier Universitaire de Nīmes
name: University Hospital, Grenoble
name: Hospital of Mulhouse
name: Hospital of Valence
First posted: 2009-11-05
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: size of residual pneumothorax measured on chest radiography
timeFrame: one day
Secondary outcomes:
measure: size of residual pneumothorax at one week
timeFrame: one week
measure: recidive of pneumothorax at one year
timeFrame: one year
Other outcomes:
Locations:
city: Vesoul
country: France
facility: Centre Hospitalier Intercommunal de la Haute Saône
state: Franche Comté
city: Angers
country: France
facility: CHU Angers
city: Aurillac
country: France
facility: Hôpital Henri Mondor
city: Belfort
country: France
facility: Centre Hospitalier
city: Besançon
country: France
facility: CHU Besancon
city: Bethune
country: France
facility: CH Bethune
city: Boulogne sur Mer
country: France
facility: CH Boulogne sur Mer
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Henin Beaumont
country: France
facility: Clinique de HENIN BEAUMONT
city: Lomme
country: France
facility: CH Lomme
city: Marseille
country: France
facility: CHU Marseille
city: Montfermeil
country: France
facility: Chi Le Raincy/Montfermeil
city: Mulhouse
country: France
facility: CH Mulhouse
city: Nimes
country: France
facility: CHU Nimes
city: Perpignan
country: France
facility: CH Perpignan
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Roubaix
country: France
facility: CHR Roubaix
city: Rouen
country: France
facility: CH Rouen
city: Saint Etienne
country: France
facility: CHU Saint Etienne
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: Hospital University of Besancon
name: Thibaut TJ Desmettre
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Besançon
name: Thibaut DESMETTRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. No abstract available. French.