OPTImal Ventilation to Improve Pediatric Cardiac Arrest Outcomes (OPTI-VENT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,530
- 试验地点
- 40
- 主要终点
- Survival with a favorable neurologic outcome
研究概览
简要总结
Pediatric cardiac arrest is a life-threatening problem affecting >15,000 hospitalized children each year. Less than half of these children survive to hospital discharge, and neurologic morbidity is common among survivors. The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable neurological outcome (Pediatric Cerebral Performance Category Score 1-2 or no change from baseline) among children receiving at least 1 minute of CPR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 37 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invasive airway in place at the start of CPR or airway placed within the first 5 minutes
- •Received at least 1 minute of CPR.
排除标准
- •Lack of commitment to aggressive ICU therapies (e.g., CPR performed as part of end-of-life care.
- •Brain death determination prior to the CPR event.
- •Out-of-hospital cardiac arrest was the reason for initial admission to the hospital (known poor outcomes).
- •Supported by Veno-Arterial Extra Corporeal Membrane Oxygenation at the start of CPR
结局指标
主要结局
Survival with a favorable neurologic outcome
时间窗: From baseline (assessed prior to admission, or new in-hospital baseline assessed no more than 30 days prior to cardiac arrest for patients hospitalized >90 days) to the assessment at hospital discharge, estimated average of 6-12 months
Survival to hospital discharge with a favorable neurologic outcome (Pediatric Cerebral Performance Category (PCPC) score (scored on a scale of 1-6) at hospital discharge of 1 (normal), 2 (mild disability) or no worse than baseline). Percentage of subjects in control vs. intervention will be compared.
次要结局
- Ventilation rate(Two minutes after CPR start through end of CPR)