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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008228
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Dijon
Belfort Hospital
Central Hospital, Nancy, France
Norman Bethune Medical Hospital
St Philibert Hospital, Lomme
Hospital of Montfermeil
University Hospital, Brest
University Hospital, Clermont-Ferrand
Nantes University Hospital
Association Hospitalière Nord Artois Cliniques
Poitiers University Hospital
University Hospital, Tours
CHU de Reims
Hospital of Perpignan
Hospices Civils de Lyon
Centre Hospitalier Universitaire de Saint Etienne
Hospital of Roubaix
Hospital of Boulogne/mer
Assistance Publique Hopitaux De Marseille
University Hospital, Rouen
University Hospital, Angers
Centre Hospitalier le Mans
Centre Hospitalier Universitaire de Nīmes
University Hospital, Grenoble
Hospital of Mulhouse
Hospital of Valence
Information provided by (Responsible Party):
DESMETTRE, Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date  ICMJE September 9, 2009
First Posted Date  ICMJE November 5, 2009
Last Update Posted Date February 11, 2020
Study Start Date  ICMJE June 2009
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2009)
size of residual pneumothorax measured on chest radiography [ Time Frame: one day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2009)
  • size of residual pneumothorax at one week [ Time Frame: one week ]
  • recidive of pneumothorax at one year [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax
Official Title  ICMJE Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumothorax
Intervention  ICMJE
  • 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 Name: Turkel Kit
  • Procedure: thoracic tube drainage
    thoracic tube drainage will be performed with a tube Ch 16 or ch 20
    Other Names:
    • Monod Trocar
    • Chest Tube
Study Arms  ICMJE
  • Active Comparator: tube thoracic drainage
    drainage performed with tube drainage CH 16 or ch 20
    Intervention: Procedure: thoracic tube drainage
  • Experimental: exsufflation
    exsufflation with a specific thoracentesis system
    Intervention: Procedure: exsufflation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2020)
402
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2009)
400
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008228
Other Study ID Numbers  ICMJE R/2009/38
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DESMETTRE, Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE
  • Centre Hospitalier Universitaire Dijon
  • Belfort Hospital
  • Central Hospital, Nancy, France
  • Norman Bethune Medical Hospital
  • St Philibert Hospital, Lomme
  • Hospital of Montfermeil
  • University Hospital, Brest
  • University Hospital, Clermont-Ferrand
  • Nantes University Hospital
  • Association Hospitalière Nord Artois Cliniques
  • Poitiers University Hospital
  • University Hospital, Tours
  • CHU de Reims
  • Hospital of Perpignan
  • Hospices Civils de Lyon
  • Centre Hospitalier Universitaire de Saint Etienne
  • Hospital of Roubaix
  • Hospital of Boulogne/mer
  • Assistance Publique Hopitaux De Marseille
  • University Hospital, Rouen
  • University Hospital, Angers
  • Centre Hospitalier le Mans
  • Centre Hospitalier Universitaire de Nīmes
  • University Hospital, Grenoble
  • Hospital of Mulhouse
  • Hospital of Valence
Investigators  ICMJE
Principal Investigator: Thibaut TJ Desmettre Hospital University of Besancon
Principal Investigator: Thibaut DESMETTRE, MD CHU Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP