NCT02996149终止不适用
Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Changes in PaCO2
研究概览
简要总结
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) < 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed
- •Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)
- •Informed consent
排除标准
- •Therapeutic anticoagulation
- •Anti-platelet therapy exceeding the use of acetylsalicylic acid
- •Severe pulmonary hypertension
结局指标
主要结局
Changes in PaCO2
时间窗: 3 months after endoscopic lung volume reduction (ELVR)
次要结局
- Changes in PaCO2(6 and 12 months after ELVR)
- Changes in FEV1(3, 6 and 12 months after ELVR)
- Changes in vital capacity(3, 6 and 12 months after ELVR)
- Changes in residual volume(3, 6 and 12 months after ELVR)
- Changes in 6-minute walk distance(3, 6 and 12 months after ELVR)
- Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)(3, 6 and 12 months after ELVR)
- Changes in BMI(3, 6 and 12 months after ELVR)
研究者
Dr. Hans Klose
Dr.
Universitätsklinikum Hamburg-Eppendorf
研究点 (1)
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