Overview

This trial is active, not recruiting.

Condition pneumothorax
Treatments exsufflation, thoracic tube drainage
Sponsor Centre Hospitalier Universitaire de Besancon
Collaborator Centre Hospitalier Universitaire Dijon
Start date June 2009
End date March 2014
Trial size 400 participants
Trial identifier NCT01008228, R/2009/38

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
drainage performed with tube drainage CH 16 or ch 20
thoracic tube drainage Monod Trocar
thoracic tube drainage will be performed with a tube Ch 16 or ch 20
(Experimental)
exsufflation with a specific thoracentesis system
exsufflation 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

Primary Outcomes

Measure
size of residual pneumothorax measured on chest radiography
time frame: one day

Secondary Outcomes

Measure
size of residual pneumothorax at one week
time frame: one week
recidive of pneumothorax at one year
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax
Principal investigator Thibaut TJ Desmettre
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Besancon.