Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Efficient ventilation
研究概览
简要总结
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR.
详细描述
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. This study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR. This study may provide information if paramedics in an emergency should ventilate as they do traditionally with bag-valve mask ventilation or if they should ventilate with a laryngeal tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Cardiac arrest
排除标准
- •Paramedic does not want to use laryngeal tube
- •Physician on site before paramedic
- •Foreign body airway obstruction
结局指标
主要结局
Efficient ventilation
时间窗: From start of paramedic ventilating the patient during CPR until emergency physician takes over ventilation or patient breathes again spontaneously after return of spontaneous circulation (ROSC)
Does chest rise clearly during CPR? Thus efficient ventilation will be assessed during CPR, which may last on average between 20 and 60min. Therefore efficient ventilation will be assessed from starting CPR at 0min to 20min or rarely 60min or longer.
次要结局
- Aspiration(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month after enrollment of the last patient at August 30th 2014)
研究者
Michael Baubin, MD
Prof. MD
Medical University Innsbruck