NL-OMON52962已完成不适用
A prospective randomized controlled trial on the Systemic effects of bronchoscopic Lung Volume reduction in patients with severe Emphysema. - SOLVE study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- FEV1 <=45%pred AND FEV1/FVC <70%.
- •- TLC >100%pred AND RV>175%pred.
- •- CAT >=10.
- •- >50% emphysema destruction @-910HU.
- •- >95% complete major fissure measured by quantitative CT analysis.
- •- Non-smoking >6 months.
- •- Signed informed consent.
排除标准
- •- PaCO2>8.0 kPa, or PaO2<6.0kPa.
- •- 6-minute walk test <160m.
- •- Significant chronic bronchitis, bronchiectasis, or other infectious lung
- •- 3 or more hospitalizations due to pulmonary infection within last 12 months
- •before baseline assessments
- •- Previous lobectomy, LVRS, or lung transplantation.
- •- LVEF<45% and or RVSP>50mmHg.
- •- Anticoagulant therapy which cannot be weaned off prior to procedure.
- •- Patient is significantly immunodeficient.
- •- Involved in other pulmonary drug studies within 30 days prior to this study.
- •- Pulmonary nodule which requires intervention
- •- Any disease or condition that interferes with completion of initial or
- •follow-up assessments
研究者
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