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临床试验/NCT02792855
NCT02792855已完成不适用

Randomized Study Comparing the "sniffing Position" , "Simple Head Extension" and "Neutral Position" for Awake Orotracheal Intubation With Fiberoptic in Anticipate Difficult Airway Patients

The First Hospital of Qinhuangdao1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Intubation Time

研究概览

简要总结

The simple head extension is recommended for optimization of glottic visualization during awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date has confirmed its superiority over "sniffing position" . In a prospective, randomized study, the authors compared the sniffing position , simple head extension and "Neutral Position" in awake orotracheal Intubation.

详细描述

The study included seventy-five patients with anticipated difficult airways. The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. The extension head position was obtained by by placement of a 7-cm cushion under the shoulder.

The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group) Randomization was performed by placing index cards with the letter NP or SP or EP into75 sealed envelopes , which were then placed in random order. At the time of a patient's enrollment, the next available envelope was placed with the patient's chart. At the time of intubation, the envelope was opened and the sequence was thus determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI greater than 30 kg/m2
  • ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

排除标准

  • Exclusion criteria included age younger than 18 yr
  • ASA class IV or V
  • Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

结局指标

主要结局

Intubation Time

时间窗: Ten minutes

The primary endpoints were the time to view the vocal cords (TVC) which was taken when the operator indicated verbally that he view the vocal cords and the time to successful tracheal intubation (TSI). TSI was defined as the time taken from insertion of the FOB between the teeth until the appearance of a capnograhy curve.

次要结局

  • Occurrence of throat pain measured by VAS(one day Postoperative)

研究者

发起方
The First Hospital of Qinhuangdao
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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