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PneumothoraxEXPREDNCT01008228

Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax

A study testing exsufflation and thoracic tube drainage in people with Pneumothorax, run by Centre Hospitalier Universitaire de Besancon at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Pneumothorax
What is being tested?
exsufflation and thoracic tube drainage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
24 sitesFrance
Study dates
Jun 2009to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • recidive of pneumothorax
  • traumatic pneumothorax
  • pneumothorax with pleural effusion
  • bilatéral pneumothorax
  • pneumothorax with pulmonary disease

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • CHU Angers

    Angers, 49100

  • Hôpital Henri Mondor

    Aurillac, 15000

  • Centre Hospitalier

    Belfort, 90016

  • CHU Besancon

    Besançon, 25030

  • CH Bethune

    Béthune, 62400

  • CH Boulogne sur Mer

    Boulogne-sur-Mer, 62320

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • CHU Dijon

    Dijon, 21033

  • CHU Grenoble

    Grenoble, 38043

  • Clinique de HENIN BEAUMONT

    Hénin-Beaumont, 62110

  • CH Lomme

    Lomme, 59160

  • CHU Marseille

    Marseille, 13385

  • Chi Le Raincy/Montfermeil

    Montfermeil, 93370

  • CH Mulhouse

    Mulhouse, 68051

  • CHU Nimes

    Nîmes, 30029

  • CH Perpignan

    Perpignan, 66046

  • CHU Poitiers

    Poitiers, 86000

  • CHU Reims

    Reims, 54035

  • CHR Roubaix

    Roubaix, 59100

  • CH Rouen

    Rouen, 76000

  • CHU Saint Etienne

    Saint-Etienne, 42050

  • CHU Toulouse

    Toulouse, 31059

  • CHU Tours

    Tours, 37040

  • Centre Hospitalier Intercommunal de la Haute Saône

    Vesoul, Franche Comté, 70000

Other trials in France

About this study

Official title: 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.

Conditions
Pneumothorax
Being tested
exsufflation, thoracic tube drainage
Keywords
spontaneous, primary, first episode
Medical subject headings
Pneumothorax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exsufflationProcedure or surgery

    Also called Turkel Kit

    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 drainageProcedure or surgery

    Also called Monod Trocar, Chest Tube

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

Study groups in NCT01008228
Study groupRoleWhat they receive
tube thoracic drainageActive comparatordrainage performed with tube drainage CH 16 or ch 20
Receives: Procedure: thoracic tube drainage
exsufflationExperimentalexsufflation with a specific thoracentesis system
Receives: Procedure: exsufflation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. size of residual pneumothorax measured on chest radiography

    Measured: one day

Secondary outcomes (2)

  1. size of residual pneumothorax at one week

    Measured: one week

  2. recidive of pneumothorax at one year

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionMar 2014
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008228
Sponsor's protocol ID
R/2009/38
Acronym
EXPRED
Status last verified
Feb 2020
First submitted
9 Sep 2009
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 21277468

  • 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.

    PubMed 21482337

  • 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.

    PubMed 23318185

  • 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.

    PubMed 36693146

Questions about this trial

What is this clinical trial studying?

A study testing exsufflation and thoracic tube drainage in people with Pneumothorax, run by Centre Hospitalier Universitaire de Besancon at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

size of residual pneumothorax measured on chest radiography (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01008228, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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