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Completed

NCT Number: NCT01008228

Comparison of Exsufflation Versus Drainage in 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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal de la Haute Saône, Vesoul, Franche Comté, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exsufflation

Procedure

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

thoracic tube drainage

Procedure

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

Other names: Monod Trocar, Chest Tube

Primary outcomes

  1. size of residual pneumothorax measured on chest radiography

    Time frame: one day

Secondary outcomes

  1. size of residual pneumothorax at one week

    Time frame: one week

  2. recidive of pneumothorax at one year

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Assistance Publique Hopitaux De Marseille
  • Association Hospitalière Nord Artois Cliniques
  • Belfort Hospital
  • CHU de Reims
  • Central Hospital, Nancy, France
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier Universitaire de Nīmes
  • Centre Hospitalier Universitaire de Saint Etienne
  • Centre Hospitalier le Mans
  • Hospices Civils de Lyon
  • Hospital of Boulogne/mer
  • Hospital of Montfermeil
  • Hospital of Mulhouse
  • Hospital of Roubaix
  • Hospital of Valence
  • Nantes University Hospital
  • Norman Bethune Medical Hospital
  • Perpignan Hospital Center
  • Poitiers University Hospital
  • St Philibert Hospital, Lomme
  • University Hospital, Angers
  • University Hospital, Brest
  • University Hospital, Clermont-Ferrand
  • University Hospital, Grenoble
  • University Hospital, Rouen
  • University Hospital, Tours

Registry information

Official study title

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

Acronym: EXPRED

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Nov 5, 2009
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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