A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- The duration of length of stay of each technique
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy:
- whether manual aspiration will shorten hospital admission.
- whether the lung will expand by means of clinical and radiological findings.
详细描述
No consensus has been defined concerning the exact treatment of a first episode of SP. Literature suggests similar immediate and long-term efficacy of manual aspiration and chest tube drainage. Morbidity of manual aspiration is low and the procedure is well tolerated. Manual aspiration is safe with a complication rate of only 1 % and can be performed in the outpatient clinic in the majority of patients reducing costs. Our aim is to re - evaluate these findings with a mono-centre study with 114 patients, set-up for the first time in the Netherlands with an expectancy to confirm the former findings.
Aim of the study:
To evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy:
- whether manual aspiration will shorten hospital admission.
- whether the lung will expand by means of clinical and radiological findings.
Study design: prospective single-centre, open randomised trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a first episode of a symptomatic pneumothorax admitted to the ER of the hospital (spontaneous or traumatic) or
- •patients with an asymptomatic pneumothorax with a size of ≥ 20 % as estimated by Light's formula
- •age ≥ 18 and < 85 years
- •smoking is tolerated
排除标准
- •recurrent pneumothorax
- •lung fibrosis
- •patients with (lung) cancer
- •pregnant women
- •comorbidity limiting decision making (psychiatric disease, alcohol or drug abuse)
- •prior randomisation
- •Marfan syndrome
- •COPD patients
- •tension pneumothorax
- •multitrauma patients
结局指标
主要结局
The duration of length of stay of each technique
时间窗: 1 year
次要结局
- The success rate of each technique(1 year)