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临床试验/NCT02967952
NCT02967952Unknown不适用

A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)

National Taiwan University Hospital0 个研究点目标入组 852 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
852
主要终点
survival to admission

研究概览

简要总结

In this 3-year successive research plan, investigators will conduct a prehospital randomized controlled trial to address the following question: In adult patients with non-traumatic cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation cause a better chance of sustained recovery of spontaneous circulation and other survival outcomes like neurologically favorable status, comparing to those who receiving supraglottic airway device.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 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; OHCA
  • •age ≥ 20 years old
  • •non-traumatic cause

排除标准

  • •signs of obvious death, eg. decapitation or rigor mortis
  • •theoretically not suitable for ETI, eg. facial deformity or third-trimester pregnancy
  • •theoretically not suitable for SGA, eg. foreign-body airway obstruction
  • •with "do not attempt resuscitation" order
  • •the occurrence of OHCA during ambulance transport
  • •ROSC in the field with clear consciousness and spontaneous adequate ventilation
  • •advanced airway being established before the arrival of paramedics

研究组 & 干预措施

supraglottic airway (SGA)

Active Comparator

Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of supraglottic airway (SGA).

干预措施: supraglottic airway (SGA) V.S. endotracheal intubation (ETI) (Device)

endotracheal intubation (ETI)

Active Comparator

Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of endotracheal intubation (ETI).

干预措施: supraglottic airway (SGA) V.S. endotracheal intubation (ETI) (Device)

结局指标

主要结局

survival to admission

时间窗: One month after event

Measurement of outcome by standard Utstein OHCA registry system in Taipei City

次要结局

  • survival to discharge(One month after event)
  • favorable neurologic outcome(One month after event)
  • any ROSC(One month after event)

研究者

申办方类型
Other
责任方
Sponsor

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