ACTRN12611000184976进行中（未招募）未知
A randomised controlled trial of conservative versus interventional treatment of primary spontaneous pneumothorax
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 323
研究概览
简要总结
The novel treatment approach of observation was as good as intervention in people with a primary spontaneous pneumothorax. The observation group had fewer adverse events and were less likely to get another pneumothorax within the next 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 14 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Primary spontaneous pneumothorax that is 32% or larger (using method of Collins et al Am J Roentgenol. 1995; 165: 1127-30)
排除标准
- •Secondary pneumothorax, defined as pneumothorax occurring in the setting of acute trauma (including iatrogenic) or underlying lung disease including but not limited to COPD, pulmonary fibrosis, TB, cystic fibrosis, lung cancer and asthma that requires regular preventative medication or has been symptomatic within the last two years 2. Previous spontaneous pneumothorax on the same side 3. Coexistent haemothorax (i.e. spontaneous haemopneumothorax) 4. Bilateral pneumothorax 5. Clinical instability suggesting tension pneumothorax; respiratory distress persisting despite oxygen and parenteral narcotic analgesia (RR >30/min or SpO2 <90%), SBP <90 mmHg, HR greater than or equal to SBP. 6. Pregnancy at time of enrolment 7. Social circumstances whereby the patient either does not have adequate support after discharge to re-attend hospital if required, or is unlikely to present for study follow up. 8. Air travel within the next 12 weeks if this cannot be deferred should the pneumothorax be slow to resolve
研究者
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