NCT01008228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

4.8 years

First QC Date

September 9, 2009

Last Update Submit

February 10, 2020

Conditions

Pneumothorax

Keywords

spontaneousprimaryfirst episode

Outcome Measures

Primary Outcomes (1)

  • size of residual pneumothorax measured on chest radiography

    one day

Secondary Outcomes (2)

  • size of residual pneumothorax at one week

    one week

  • recidive of pneumothorax at one year

    one year

Study Arms (2)

tube thoracic drainage

ACTIVE COMPARATOR

drainage performed with tube drainage CH 16 or ch 20

Procedure: thoracic tube drainage

exsufflation

EXPERIMENTAL

exsufflation with a specific thoracentesis system

Procedure: exsufflation

Interventions

exsufflationPROCEDURE

exsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes

Also known as: Turkel Kit
exsufflation
thoracic tube drainagePROCEDURE

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

Also known as: Monod Trocar, Chest Tube
tube thoracic drainage

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Centre Hospitalier Intercommunal de la Haute Saône

Vesoul, Franche Comté, 70000, France

Location

CHU Angers

Angers, 49100, France

Location

Hôpital Henri Mondor

Aurillac, 15000, France

Location

Centre Hospitalier

Belfort, 90016, France

Location

CHU Besancon

Besançon, 25030, France

Location

CH Bethune

Béthune, 62400, France

Location

CH Boulogne sur Mer

Boulogne-sur-Mer, 62320, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Dijon

Dijon, 21033, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Clinique de HENIN BEAUMONT

Hénin-Beaumont, 62110, France

Location

CH Lomme

Lomme, 59160, France

Location

CHU Marseille

Marseille, 13385, France

Location

Chi Le Raincy/Montfermeil

Montfermeil, 93370, France

Location

CH Mulhouse

Mulhouse, 68051, France

Location

CHU Nimes

Nîmes, 30029, France

Location

CH Perpignan

Perpignan, 66046, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CHU Reims

Reims, 54035, France

Location

CHR Roubaix

Roubaix, 59100, France

Location

CH Rouen

Rouen, 76000, France

Location

CHU Saint Etienne

Saint-Etienne, 42050, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CHU Tours

Tours, 37040, France

Location

Related Publications (4)

  • 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.

    PMID: 21277468BACKGROUND

  • 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.

    PMID: 21482337BACKGROUND

  • 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.

    PMID: 23318185BACKGROUND

  • 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.

    PMID: 36693146DERIVED

MeSH Terms

Conditions

Pneumothorax

Interventions

Chest Tubes

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Thibaut TJ Desmettre

    Hospital University of Besancon

    PRINCIPAL INVESTIGATOR

  • Thibaut DESMETTRE, MD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Thibaut Desmettre, MD, PhD

Study Record Dates

First Submitted

September 9, 2009

First Posted

November 5, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2014

Study Completion

December 1, 2015

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

FR(24)