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临床试验/NCT01091948
NCT01091948已完成不适用

GlideScope Video Laryngoscope vs Fiberoptic Intubation

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2008年2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
75
试验地点
2
主要终点
Time to Intubation (TTI) as Measured in Seconds

研究概览

简要总结

Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years old
  • scheduled for elective surgery requiring orotracheal intubation.

排除标准

  • known, difficult airway
  • loose teeth
  • require a rapid sequence induction,
  • Body Mass Index under 30
  • unable to give consent
  • if special endotracheal tube (ETT) is needed for the case.

结局指标

主要结局

Time to Intubation (TTI) as Measured in Seconds

时间窗: from start of intubation to successfully intubated up to 100 seconds

Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).

次要结局

  • Intubation Difficulty Score(from start of intubation to successfully intubated)
  • Successful Intubation on 1st Attempt(from start of first intubation to end of first intubation attempt)
  • Occurrence of Hypoxaemia(at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after)
  • Trace Bleeding(Right after intubation)
  • Sore Throat Grade(On the first postoperative day)
  • Number of Intubation Attempts(from start of intubation to successfully intubated)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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