Initial management of well tolerated but voluminous primary pneumothorax : intercostal chest tube versus needle aspiration.
Phase 3
Recruiting
- Conditions
- Respiratory
- Registration Number
- PACTR202002728476768
- Lead Sponsor
- nidhal belloumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
age above eighteen years old
normal neurological state
written informed consent
First episode of large pneumothorax defined by a volume surpassing 41% of thoracic volume, which correspond to an interpleural distance over 8 cm according to Collins Formula.
No radiological sign of an underlying pulmonary disease
No signs of a non tolerated pneumothorax
Exclusion Criteria
Past medical history of pneumothorax
Radiological sign of secondary pneumothorax
Hydropneumothorax
Bilateral pneumothorax
clinical signs of a non tolerated pneumothorax : oxymetry< 90% , schock index PAS/FC < 1
HIV infection
impossibility to consent due to mental impairement
incarceration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate 5 days after procedure of pneumothorax evacuation - Success for manual aspiration was defined as complete<br>or nearly complete and persistent lung expansion. Tolerated interpleural distance in the apex is less than 1 cm - Success for chest tube drainage was defined as complete lung expansion, absence of air leakage , and soft aspiration removal within 5 days after tube placement -<br><br>;recurrence rate over one year of follow up
- Secondary Outcome Measures
Name Time Method Immediate success rate after procedure of pneumothorax evacuation - Immediate success for manual aspiration was defined as complete<br>or nearly complete and persistent lung expansion immediately following manual aspiration. - Immediate success for chest tube drainage was<br>defined as complete lung expansion, absence of air leakage in less than 48 hours after tube placement -<br><br>;need for pleurodesis in case of persistence of pneumothorax;Hospitalization duration<br><br>