Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hyperinflation Assessment After Treatment
研究概览
简要总结
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema
详细描述
Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe emphysema (recent CT-scan (< 6 mois) )
- •Age > 35 ans
- •Modified Medical Research Council Scale (mMRC) > 2
- •Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45%
- •Residual volume > 175%
- •Total Pulmonary capacity > 100%
排除标准
- •Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator
- •Carbon Monoxide Diffusing Capacity (TLCO) < 20%
- •Recurrent respiratory infection Infections with clinics symptoms
- •Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg
- •Impossibility to walk more that 140 meter (6 min test)
- •Surgery history of volume reduction or pulmonary transplantation
- •Broncho-dilatation with clinic symptoms
研究组 & 干预措施
Patient with severe emphysema
Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy
干预措施: Bronchoscopy (Procedure)
Patient with severe emphysema
Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy
干预措施: Lung Volume Reduction Coil (HEAT-LVRC) (Device)
结局指标
主要结局
Hyperinflation Assessment After Treatment
时间窗: 3 months
Assessed by Lung Volume Reduction Coil
次要结局
未报告次要终点