NCT02090218终止不适用
I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial
Haukeland University Hospital8 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 550
- 试验地点
- 8
- 主要终点
- ventilation success
研究概览
简要总结
The main objective of this trial is to compare the effectiveness of a newer supraglottic airway method (the i-Gel), compared to current airway management practice in out-of-hospital cardiac arrests treated by Norwegian ambulance services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-of-hospital cardiac arrest patients requiring and receiving advanced airway management on ambulance missions. Advanced airway management is defined as the attempted insertion of an airway adjunct (I-Gel, laryngeal tube or ETI) or the administration of ventilatory assistance/support (including bag-mask ventilation (BMV) or other ventilatory support.
- •Adult patients (> 18 years).
排除标准
- •Non-adult patients / minors (< 18 years).
- •Traumatic cardiac arrest.
结局指标
主要结局
ventilation success
时间窗: up to 24 hours
ventilation success defined as successful insertion of device with visible chest movement with each ventilation, audible air passage on auscultation, and ETCO2 confirmation (if available) of tube placement
次要结局
- survival to hospital discharge / 30-day survival(up to 30 days)
- insertion related complications(up to 24 hours)
- cerebral function assessed by Glascow Outcome Score at discharge from hospital(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- levels of ETCO2 related to the presence and quality of bystander CPR(up to 24 hours)
研究者
研究点 (8)
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