Extracorporeal Membrane Oxygenation (ECMO) and Neonatal Outcomes:a Retrospective Multicenters Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 28 days' mortality
研究概览
简要总结
Since the 1970s, extracorporeal membrane oxygenation (ECMO) support has been used to support gas exchange for children with severe acute respiratory failure who fail mechanical ventilation. ECMO is more expensive than each of these other procedures.But its action is unclear
详细描述
Since 1974, eight randomized controlled trials have been reported in ECMO for respiratory failure, and none have included non-neonatal pediatric patients. Cochrane systematic reviews of this evidence concluded that ECMO for neonatal respiratory failure had a survival advantage, but there was insufficient evidence to demonstrate a survival advantage for ECMO used to support respiratory failure in adults. Moreover, these trials were performed prior to 2009, and since then advances in ECMO technology have enhanced the delivery of ECMO support, and new research has changed conventional management of severe acute respiratory distress syndrome (ARDS)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Hour 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECMO group:
- •Oxygenation Index > 40 for >4 hours
- •Failure to wean from 100% oxygen despite prolonged (> 48h) maximal medical therapy or persistent episodes of decompensation
- •Severe hypoxic respiratory failure with acute decompensation (PaO2 <40) unresponsive to intervention
- •Severe pulmonary hypertension with evidence of right ventricular dysfunction and/or left ventricular dysfunction. The pulmonary artery pressure > 60mmHg evaluated by the Echo, arterial duct keeps open and the blood flow was either by-level shunt or completely shunt from right side to left side.
- •Non-ECMO group:
- •Oxygenation Index > 16 and reach the Montreux definition of severe respiratory distress syndrome
- •Vasoactive-inotropic score (VIS) ≥ 40 [VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100]
排除标准
- •Gestational age < 36 weeks, birth weight < 2 kg, day post-birth > 28 days.
- •lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly
- •irreversible brain damage
- •uncontrolled bleeding
- •Grade III or greater intraventricular hemorrhage
- •ventilator days ≥ 15 days.
结局指标
主要结局
28 days' mortality
时间窗: 28 days
the patients died
in-hospital mortality
时间窗: 36 weeks' gestational age or before discharge from hospital
the patients died
次要结局
- Intraventricular hemorrhage(36 weeks' gestational age or before discharge from hospital)
- Neonatal necrotizing enterocolitis(36 weeks' gestational age or before discharge from hospital)
- bronchopulmonary dysplasia(36 weeks' gestational age or before discharge from hospital)
研究者
Chen Long,MD
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University