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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

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.

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: exsufflation Procedure: thoracic tube drainage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax
Study Start Date : June 2009
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 2015


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 Name: Turkel Kit




Primary Outcome Measures :
  1. size of residual pneumothorax measured on chest radiography [ Time Frame: one day ]

Secondary Outcome Measures :
  1. size of residual pneumothorax at one week [ Time Frame: one week ]
  2. recidive of pneumothorax at one year [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008228


Locations
Show Show 24 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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
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Principal Investigator: Thibaut TJ Desmettre Hospital University of Besancon
Principal Investigator: Thibaut DESMETTRE, MD CHU Besançon
Publications:
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Responsible Party: DESMETTRE, Dr Thibaut Desmettre, MD, PhD, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01008228    
Other Study ID Numbers: R/2009/38
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Keywords provided by DESMETTRE, Centre Hospitalier Universitaire de Besancon:
spontaneous
primary
first episode
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases