NL-OMON49774已完成不适用
Conversion of collateral ventilation in CV-positive emphysema patients before endobronchial valve treatment - a pilot study (*MIND THE GAP CROSSING BORDERS*) - Mind the Gap Crossing Borders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Diagnosis of emphysema
- •2. Subjects of both genders of at least 35 years of age at the time of the
- •baseline visit.
- •3. Understand and voluntarily sign a patient informed consent form.
- •4. 15 % predicted <= FEV1 <= 50% predicted.
- •5. RV >= 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted.
- •6. 6MWD >= 140 meters.
- •7. Dyspnea score of >=2 on the mMRC scale of 0-4.
- •8. Non-smoker > 6 months prior to signing the informed consent.
- •9. Chartis CV positive between target and ipsilateral lobe
排除标准
- •1. Evidence of active pulmonary infection.
- •2. Evidence of clinically significant bronchiectasis.
- •3. History of more than 3 exacerbations with hospitalizations over the past 12
- •4. Subject has DLCO <20% of predicted.
- •5. Myocardial infarction or other relevant cardiovascular events in the past 6
- •6. Prior lung surgery, Lung volume reduction surgery, lung transplantation,
- •lobectomy, or pneumonectomy.
- •7. Prior endoscopic lung volume reduction.
- •8. Unstable pulmonary nodule requiring follow-up
- •9. Pregnant of nursing women.
- •10. Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 <
- •6.0kPa, both measured on room air.
- •11. Any disease with high probability of mortality within 24 months.
- •12. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant
- •therapy (such as LMWH or coumarins).
- •13. Patient was involved in other pulmonary drug studies within 30 days prior
- •to this study.
研究者
相似试验
已完成
不适用
Proactive treatment of collateral ventilation in CV-positive emphysema patients before EBV treatment.COPD10038716emphysemaNL-OMON41669niversitair Medisch Centrum Groningen20
已完成
不适用
Measuring collateral ventilation using Chartis® to select patients with severe emphysema for endobronchial valve treatment: conscious sedation versus general anesthesiaEmphysemaNL-OMON46522niversitair Medisch Centrum Groningen30
招募中
Unknown
Impact of continuous 'above cuff ventilation' on aspiration status in neurogenic dysphagiaR13.1DRKS00033639Helios Klinikum Krefeld GmbH56
已完成
不适用
The effect of spontaneous ventilation with mask on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia;otherwise healthy parturients planned for cesarean sectionAnaesthesiology - Other anaesthesiologyACTRN12616000625471Harran University School of Medicine, Research and Training Hospital60
已完成
不适用
Would continued ventilation during cardiopulmonary bypass reduce lung complications following cardiac surgery?ISRCTN25577630Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)23