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Pneumothorax | Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax

Pneumothorax research study

What is the primary objective of this study?

We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.

Who is eligible to participate?

Inclusion Criteria: 1. Age between 15 and 50 years old. 2. First episode of spontaneous pneumothorax. 3. The rim of air is > 2cm on CXR requiring simple aspiration 4. Aspiration as the initial treatment 5. Failed to achieve lung expansion following repeat manual aspiration Exclusion Criteria: 1. Complete or nearly complete and persistent lung expansion immediately following manual aspiration 2. With underlying pulmonary disease (TB, asthma, etc) 3. With hemothorax or tension pneumothorax requiring chest tube insertion or operation 4. A history of previous pneumothorax 5. A history of previous ipsilateral thoracic operation 6. Pregnant or lactation female

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pneumothorax

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Video-assisted thoracoscopic surgeryVATS for bullectomy and mechanical pleurodesis

Procedure:chest tube drainageChest tube drainage for pneumothroax

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Surgery: Video-assisted thoracoscopic surgery

2Chest tube drainage

Study Status

Unknown status

Start Date: April 2008

Completed Date: September 2013

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Comparing the number of days in hospital, after intervention, of each group.

Secondary Outcome: Short-term outcome, including number of days with chest drainage, total hospital stay, short-term failure rate of assigned treatment, adverse events, pain score, mean dose of meperidine requested.

Study sponsors, principal investigator, and references

Principal Investigator: Yung-Chie Lee, MD, PhD

Lead Sponsor: National Taiwan University Hospital

Collaborator: Department of Health, Executive Yuan, R.O.C. (Taiwan)

More information:https://clinicaltrials.gov/show/NCT00713362

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