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临床试验/NCT06067204
NCT06067204招募中不适用

Prehospital Automatic Ventilation on Resuscitation Outcomes in Out-of-hospital Cardiac Arrest Patients: a Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2023年10月2日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
514
试验地点
1
主要终点
The percentage of any return of spontaneous circulation (ROSC)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. The intervention group is automatic ventilation and the control group is manual ventilation. The main questions it aims to answer are:

  1. How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation.
  2. What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Only the emergency medical service crew will know the intervention in each participant. The patient will not be aware of the type of ventilation strategy because of OHCA status. The investigator and outcomes assessor will not able to acquire the allocation results until the study ends.

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

  • •Age over 18 years old at the time of occurrence of out-of-hospital cardiac arrest (OHCA).
  • •Attended by the Hsinchu County Fire Department for emergency medical assistance.

排除标准

  • •Pregnant women.
  • •OHCA caused by trauma.
  • •Return of spontaneous circulation (ROSC) observed at the scene.
  • •Clearly deceased at the scene (reaching conditions such as decomposition, rigor mortis, severe burns, decapitation, evisceration, or trunk fracture).
  • •Refusal of medical transportation by family members.
  • •No placement of an advanced airway throughout the procedure.

结局指标

主要结局

The percentage of any return of spontaneous circulation (ROSC)

时间窗: 2 hours

The patient achieved ROSC in prehospital or inhospital resuscitation.

次要结局

  • The percentage of sustained ROSC in 24 hours(up to 24 hours)
  • The percentage of epinephrine injection(up to 1 hour)
  • The satisfaction of emergency medical technician (EMT) during the dispatch(up to 5 hours)
  • The percentage of intravenous catheter placement(up to 1 hour)
  • The percentage of survival to hospital discharge(up to 90 days)
  • The percentage of favorable neurological outcome after discharge(up to 90 days)
  • Chest compression fraction(up to 1 hour)
  • The percentage of pneumothorax(up to 3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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