The Physiological Changes Following Bronchoscopic Lung Volume Reduction Treatment for Chronic Obstructive Pulmonary Disease (COPD)

niversity of Adelaide0 个研究点目标入组 50 人开始时间: 2018年11月6日最近更新: 2019年7月15日

适应症

试验速览

暂无简介。

•Established diagnosis of COPD with hyperinflation: post-bronchodilator FEV1 <50% of predicted AND TLC > 100% AND RV>175%
•- The absence of any collateral ventilation between target lobe and ipsilateral lobe, diagnosed with quantitative CT fissure integrity of >90% and confirmation of integrity with Chartis measurement.
•- Age >18 and <75 at the time of enrolment.
•- 6-min walk test distance >150m following successful completion of a pulmonary rehabilitation program (or equivalent program).
•- No evidence of significant coexistent pulmonary pathology on HRCT
•- Able to safely undergo sedation or general anesthesia and bronchoscopy
•- Cessation of smoking for 3 months prior

•Any patient deemed not suitable for EBV insertion based on internationally accepted best-practice guidelines. Considerations include:
•- Significant co-existent pulmonary pathology
•- Severe Hypercapnia (pCO2 > 60mmHg on room air)
•- Unstable cardiovascular disease
•- Severe heart failure: EF <35%
•- Unstable cardiac arrhythmia, myocardial infarction or stroke within 6 months
•- Severe PAH: RVSP >45mmHg
•- Current Smoker
•- 6MWT distance less than 150m post pulmonary rehabilitation or equivalent program
•- FEV1 <15% predicted
•- Any device or foreign object deemed unsafe for MRI (e.g. Pacemaker, shrapnel etc.)
•- Pregnancy or potentially pregnant
•- Egg or protein allergies

发起方

niversity of Adelaide