Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax

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.

Conditions

• Pneumothorax

Interventions

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

PROCEDURE

thoracic tube drainage

thoracic tube drainage will be performed with a tube Ch 16 or ch 20

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• Belfort Hospital

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• Norman Bethune Medical Hospital

  collaborator OTHER

• St Philibert Hospital, Lomme

  collaborator UNKNOWN

• Hospital of Montfermeil

  collaborator UNKNOWN

• University Hospital, Brest

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Association Hospitalière Nord Artois Cliniques

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• CHU de Reims

  collaborator OTHER

• Centre hospitalier de Perpignan

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• Centre Hospitalier Universitaire de Saint Etienne

  collaborator OTHER

• Hospital of Roubaix

  collaborator UNKNOWN

• Hospital of Boulogne/mer

  collaborator UNKNOWN

• Assistance Publique Hopitaux De Marseille

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• Centre Hospitalier le Mans

  collaborator OTHER

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Hospital of Mulhouse

  collaborator UNKNOWN

• Hospital of Valence

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Besancon

  lead OTHER

Principal Investigators

• Thibaut TJ Desmettre · Hospital University of Besancon

• Thibaut DESMETTRE, MD · CHU Besançon

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2014-03-31

Completion

2015-12-31

Countries

• France

Study Locations