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临床试验/NCT02578992
NCT02578992已完成不适用

"Neutral Head Position" and "Head-lift Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults

Tri-Service General Hospital2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2014年12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
130
试验地点
2
主要终点
Intubation Time

研究概览

简要总结

The purpose of this study is to investigate two different patient's head and neck positions(neutral head position and head-lift position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.

详细描述

The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for various surgeries requiring general anesthesia with tracheal intubation
  • American Society of Anesthesiologists(ASA) physical status classification I-III

排除标准

  • pneumothorax
  • room air saturation by pulse oximeter saturation less than 96%
  • vocal cord palsy
  • craniofacial anomaly
  • congenital upper airway anomaly
  • upper airway disease
  • cervical spine pathology
  • head and neck tumor status post radiotherapy
  • an increased risk of regurgitation or pulmonary aspiration
  • a history of difficult tracheal intubation

结局指标

主要结局

Intubation Time

时间窗: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts

the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.

次要结局

  • Modified Cormack-Lehane Grade(during intubation, after epiglottis was identified on the video monitor)
  • Mean Arterial Pressure(before and after intubation, up to 5 minutes)
  • Visual Analog Scale of Sore Throat(after anesthesia emergence 30 minutest, at post-anesthesia care unit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei-Hung Chan

Dr.

Tri-Service General Hospital

研究点 (2)

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