Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation
赞助:
China-Japan Friendship Hospital
合作者:
信息的提供 (责任方):
Qingyuan Zhan，China-Japan Friendship Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 25, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | January 2017 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
incidence of avoid endotracheal intubation[ Time Frame: 30days ] avoid endotracheal intubation and Invasive mechanical ventilation |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Extracorporeal Carbon Dioxide Removal in Severe Chronic Obstructive Pulmonary Disease Exacerbation | ||
| 正式标题 ICMJE | Evaluation of Clinical Effectiveness of ECCO2R for the Treatment of Patients With Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease | ||
| 简要概况 | The conventional treatment for Severe acute exacerbation of Chronic obstructive pulmonary disease including noninvasive respiratory support, invasive respiratory support, etc, but there are many kinds of limitations and complications. Extracorporeal Carbon Dioxide Removal is a life support technology, which can effectively remove CO2. Recently some clinical studies have showed that ECCO2R can effectively improve the AECOPD patient's respiratory failure, avoid intubation and removal of endotracheal intubation. We performed a study to evaluate the clinical effectiveness of ECCO2R in the treatment of AECOPD patients. |
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| 详细说明 | With the development of technology, ECCO2R is not difficult to implement in intensive care unit. Many recently clinical studies have showed that ECCO2R can effectively remove CO2, reduce patient breathing work, improve the patient respiratory failure, and avoid endotracheal intubation. But there are also treated failure and high incidence of complications such as bleeding in the AECOPD patients with ECCO2R treatment, and the treatment related to airway management are less mentioned. Therefore, we set a more strict inclusion criteria in AECOPD patients and evaluate the clinical effectiveness and associated risk of ECCO2R in the treatment of AECOPD. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2020 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - NPPV treatment failure: 1. deterioration or no improvement after treatment with NPPV, pH < 7.25, PaCO2 > 70mmHg 2. Obvious respiratory distress, RR > 30 times/min 3. Breathing extreme fatigue Exclusion Criteria: - Older than 75 years - endotracheal intubation or tracheostomy - obviously a lot of pus yellow phlegm, expectorate difficult - Chest CT: obviously a wide range of consolidation - BMI < 20 kg/m2, - Dysfunction of other organ of extrapulmonary - serious hemodynamic instability - severe hypoxemia, PaO2 / FiO2 < 100mmHg - home noninvasive positive pressure ventilation for a long time - lung fungal infection - contraindication of anticoagulation - Platelet < 80000 per cubic millimeter - Serum creatinine > 200 umol/L - cardiac arrest - Hospice care - Refused to take part in the study | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：75 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: 研究涉及美国FDA监管的设备产品: |
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| IPD 共享声明 |
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| 责任方 | Qingyuan Zhan，China-Japan Friendship Hospital | ||
| 研究赞助商 ICMJE | China-Japan Friendship Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | China-Japan Friendship Hospital | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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