Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Advent of pneumothorax within 90 days following valve implantation
研究概览
简要总结
Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.
详细描述
Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. All patients will undergo treatment at one study centre in Heidelberg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 < 50%, RV>150%, TLC>100%
- •emphysema confirmed by computed tomography
- •pO2 >60 mmHg (with supplemental oxygen), pCO2 < 55 mmHg (room condition)
- •no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement)
- •no COPD exacerbation within the past 8 weeks
- •daily use of < 20 mg Prednisolon
- •non-smoking for a minimum of 4 months prior to consent
- •Patient has provided written informed consent
排除标准
- •BMI < 18 kg/m²
- •clinically relevant bronchiectasis
- •failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure
- •Prior lung resection (e.g. lobectomy)
结局指标
主要结局
Advent of pneumothorax within 90 days following valve implantation
时间窗: 90 days following valve implantation
Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.
次要结局
- Lung function before and after valve therapy(30 and 90 days following valve implantation)
- Excercise capacity before and after valve therapy(30 and 90 days following valve implantation)
- Dyspnoe score before and after valve therapy(30 and 90 days following valve implantation)
研究者
Felix JF Herth
Prof. Dr. med.
Heidelberg University