Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pulmonary function improvemnt
研究概览
简要总结
Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.
Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an inflammatory airway and parenchymal injury and consequently fibrotic response resulting in LVR;
详细描述
Inclusion criteria:
- Age 40-75 unlimited sex. 20 subjects
- chronic obstructive pulmonary disease (COPD), GOLD 3-4 (global obstructive lung disease).
- CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- Pulmonary function tests results- total lung capacity(TLC)>110%, residual volume(RV)>150%, diffusion of lung CO(DLCO)<80%,forced expiratory volume 1 second(FEV1):15-45%.
- 6 minute walking distance (6MWD)> 140 meters.
Exclusion criteria:
- Active ischemic heart disease, significant arrhythmia. ejection fraction (EF) <40%.
- COPD that cause carbon bioxide(CO2) retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- Pulmonary hypertension> 45 mmHg, according to the Echo Test.
- . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.5. Pregnancy.
Methods: . A. Patient preparation and sedation as in diagnostic bronchoscopy. Sedation will be based on midzoln + demerol. The patients will be treated prior the treatment with Inhalation with salbutamol ans ipratropium bromide. Flexible bronchoscope with outer diameter 5 mm is introduced to the targated upper lobe, and placed in wedged position. This is followed by installion of 0.9% natriu, chloride(NaCl) at a temperature of 55ºC exit temperature 50ºC) in portions of 40 ml to 200 ml (in bronchoalveolar lavage up to 300 ml is acceptable. The patient is placed in horizontal position, and continuous ECG blood pressure. Oxygen saturation are monitored. This monitoring will be continue at least 2 hours after treatment. A chest x-ray is followed and the patient remain in the department for overnight.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-75 unlimited sex. 20 subjects
- •COPD, GOLD 3-4 (global obstructive lung disease).
- •CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- •Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%.
- •6 minute walking distance > 140 meters.
排除标准
- •Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%.
- •Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- •Pulmonary hypertension> 45 mmHg, according to the Echo Test.
- •. Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
- •Pregnancy -
研究组 & 干预措施
Endoscopic lung volume reduction
After usual sedation, bronchoscope is introduce to the lung and palced in segmental wedge position then hot salineis instilled. Same procedure to others affected segments.
干预措施: Endoscopic lung volume reduction (Procedure)
结局指标
主要结局
Pulmonary function improvemnt
时间窗: 6 months
Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .
次要结局
未报告次要终点