JPRN-jRCT1092220327已完成Unknown
Treatment of severe acute respiratory failure patients requiring Extracorporeal Membrane Oxygenation (ECMO)Study protocol No.: MJ-CP042-01-01 - MJ-CP042-01-01
Getinge Group Japan K.K.0 个研究点目标入组 20 人开始时间: 2018年2月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1.Patients who are able to provide written consent to participate in the study
- •2.Ages between 20 and 75 years old; no gender restriction
- •3.Longer than 6 hours of ECMO therapy is expected
- •4.Meets at least one of the 3 criteria below:
- •-FiO2 >0.8, PFR<100mmHg, PEEP>=10cmH2O
- •-Uncompensated hypercapnia (PaCO2 >80mmHg) in spite of PIP>=30cmH2O
- •-Serious air leak syndrome
排除标准
- •1.Cause of the severe respiratory failure is determined to be irreversible respiratory disease
- •2.Remaining on high ventilator settings (FiO2 >0.9, PIP >30cmH2O) for more than 7 days
- •3.Serious immunodeficiency (Neu<400mm3)
- •4.Pre-existing conditions (central nervous system disorder, end-stage malignancy, systemic bleeding risk due to ECLS anticoagulation) which may have significant impact on QOL
- •5.Severe aortic valve insufficiency in the case of VA circulation
- •6.Patients with known hypersensitivity to heparin
- •7.Patients currently suffering from, or with a history of type II antibody-related, heparin-induced thrombocytopenia (HIT)
- •8.Pregnant or possibility of pregnancy
- •9.Participating in another clinical trial or Postmarketing clinical study
- •10.Those patients determined by the investigator to be inappropriate to participate in the trial
研究者
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