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临床试验/NCT01090726
NCT01090726已完成不适用

Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Success rate

研究概览

简要总结

The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. The investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the later, which the patient was randomized to.

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
Single (Participant)

入排标准

年龄范围
1 Month 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Elective surgical patients ASA-class 1-2 below the age of 2 years, with indication for intubation.
  • Informed consent from parent.
  • The parents must have legal custody of the child.
  • The parents must be able to read and understand Danish.

排除标准

  • Expected difficult airway.

结局指标

主要结局

Success rate

时间窗: 5 minutes

Succes is defined by intubation being executed in the first try.

次要结局

  • Time to Cormack evaluation(5 minutes)
  • Time to intubation(5 minutes)
  • Number of intubation attempts(5 Minutes)
  • Quality of laryngeal overview before intubation(5 Minutes)
  • Prevalence of post intubation stridor(12 hours)
  • Intubation conditions(5 Minutes)

研究者

申办方类型
Other

研究点 (2)

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