ACTRN12608000408381进行中（未招募）未知
Evaluation of the Safety and Feasiblity of the Portaero System Used in Transthoracic Pneumonostomy Procedure to Treat Patients With Homogeneous Emphysema
Portaero, Inc.0 个研究点目标入组 50 人开始时间: 2008年8月19日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 45 Years 至 /A（—）
- 性别
- All
入选标准
- •1. CT (computed tomography) scan consistent with severe emphysema grade of greater than or equal to 2 (per NETT, National Emphysema Treatment Trial) involving both ipsilateral upper and lower lobes
- •2. Airflow obstruction as evidenced by FEV1/FVC ratio (Forced Expiratory Volume in the first second/Forced Vital Capacity ratio) < 70% post-bronchodilator
- •3. Patients with FEV1 > 20% and < 45% of predicted post bronchodilator
- •4. Patient with hyperinflation defined as
- •a) RV (Residual Volume) > 150% of predicted post bronchodilator
- •b) TLC (Total Lung Capacity) > 100% post bronchodilator
排除标准
- •1. PaCO2 (pressure of carbon dioxide) > 60mm Hg breathing room air
- •2. 6 minute walk test distance (6MWT) < 140m after completing pulmonary rehabilitation
- •3. Patient experienced 3 or more exacerbations of COPD requiring hospitalization over previous 12 months
- •4. Patient is currently using domiciliary noninvasive ventilation (NIV) with the exception of continuous positive airway pressure (CPAP) or biphasic positive airway pressure for the treatment of obstructive sleep apnea (OSA)
- •5. BMI (body mass index) < 17 or > 31
- •6. Patient with uncontrolled hypertension, defined as blood pressure > 200/110 mmHg
- •7. Patient with severe pulmonary hypertension defined as RVESP (right ventricular end systolic pressure) = 49 mmHg by echocardiography at Screening (or documented RVSP (right ventricular systolic pressure) > 45 mmHg by right heart catheterization)
- •8. Patient with myocardial infarction within 6 months, LVEF (left ventricular ejection fraction) < 45% or any other cardiac condition / arrhythmia that poses an anesthetic risk
- •9. Patient with bleeding risk, i.e., abnormal clotting, anticoagulants that cannot be ceased peri-operatively, or thrombocytopenia (platelet count < 100 X 103/µL )
- •10. Patient with known a-1 antitrypsin deficiency
- •11. Patient who underwent previous ipsilateral LVRS (lung volume reduction surgery), lobectomy or pleural surgery.
- •12. Patient has giant bulla that occupy more than >1/3 volume of lung
- •13. Patient has known lung cancer or pulmonary nodule(s) that require investigation
- •14. Patient is currently being treated with high dose corticosteroids defined as > 10mg/day prednisone or equivalent
- •15. Female patient with positive HCG (human chorionic gonadotropin) pregnancy test at Screening.
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