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

Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax
• Intervention / Treatment: Procedure: thoracic tube drainage; Procedure: exsufflation

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers
  • Aurillac, France, 15000
    • Hôpital Henri Mondor
  • Belfort, France, 90016
    • Centre Hospitalier
  • Besançon, France, 25030
    • CHU Besançon
  • Bethune, France, 62400
    • CH Bethune
  • Boulogne sur Mer, France, 62320
    • CH Boulogne sur Mer
  • Clermont Ferrand, France, 63003
    • CHU Clermont Ferrand
  • Dijon, France, 21033
    • CHU Dijon
  • Grenoble, France, 38043
    • CHU Grenoble
  • Henin Beaumont, France, 62110
    • Clinique de HENIN BEAUMONT
  • Lomme, France, 59160
    • CH Lomme
  • Marseille, France, 13385
    • CHU Marseille
  • Montfermeil, France, 93370
    • Chi Le Raincy/Montfermeil
  • Mulhouse, France, 68051
    • CH Mulhouse
  • Nimes, France, 30029
    • CHU Nimes
  • Perpignan, France, 66046
    • Ch Perpignan
  • Poitiers, France, 86000
    • CHU Poitiers
  • Reims, France, 54035
    • CHU Reims
  • Roubaix, France, 59100
    • CHR Roubaix
  • Rouen, France, 76000
    • CH Rouen
  • Saint Etienne, France, 42050
    • Chu Saint Etienne
  • Toulouse, France, 31059
    • CHU Toulouse
  • Tours, France, 37040
    • Chu Tours
  • Franche Comté
    • Vesoul, Franche Comté, France, 70000
      • Centre Hospitalier Intercommunal de la Haute Saône

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Turkel Kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
size of residual pneumothorax measured on chest radiography	one day

Secondary Outcome Measures

Outcome Measure	Time Frame
size of residual pneumothorax at one week	one week
recidive of pneumothorax at one year	one year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Hospices Civils de Lyon; University Hospital, Angers; University Hospital, Rouen; Assistance Publique Hopitaux De Marseille; Centre Hospitalier Universitaire de Saint Etienne; Centre Hospitalier Universitaire Dijon; CHU de Reims; Central Hospital, Nancy, France; Poitiers University Hospital; University Hospital, Clermont-Ferrand; Centre Hospitalier Universitaire de Nīmes; University Hospital, Brest; University Hospital, Grenoble; Nantes University Hospital; University Hospital, Tours; Centre Hospitalier le Mans; Belfort Hospital; Norman Bethune Medical Hospital; St Philibert Hospital, Lomme; Hospital of Montfermeil; Association Hospitalière Nord Artois Cliniques; Hospital of Perpignan; Hospital of Roubaix; Hospital of Boulogne/mer; Hospital of Mulhouse; Hospital of Valence
• Investigators: Principal Investigator: Thibaut TJ Desmettre, Hospital University of Besançon; Principal Investigator: Thibaut DESMETTRE, MD, CHU Besançon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: November 4, 2009
• First Posted (Estimate): November 5, 2009

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: primary; first episode; spontaneous
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: R/2009/38