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Clinical Trials/NCT01008228
NCT01008228CompletedNot Applicable

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

Centre Hospitalier Universitaire de Besancon24 sites in 1 country402 target enrollmentStarted: June 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
402
Locations
24
Primary Endpoint
size of residual pneumothorax measured on chest radiography

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

tube thoracic drainage

Active Comparator

drainage performed with tube drainage CH 16 or ch 20

Intervention: thoracic tube drainage (Procedure)

exsufflation

Experimental

exsufflation with a specific thoracentesis system

Intervention: exsufflation (Procedure)

Outcomes

Primary Outcomes

size of residual pneumothorax measured on chest radiography

Time Frame: one day

Secondary Outcomes

  • size of residual pneumothorax at one week(one week)
  • recidive of pneumothorax at one year(one year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

DESMETTRE

Dr Thibaut Desmettre, MD, PhD

Centre Hospitalier Universitaire de Besancon

Study Sites (24)

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