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临床试验/NCT01170455
NCT01170455已完成不适用

Nasal Intubation Using the Blind Intubation Device:a Prospective,Randomized,Controlled Comparison With the Direct Laryngoscope

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年9月1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
50
试验地点
1
主要终点
Hemodynamic changes

研究概览

简要总结

The purpose of this study is to determine whether nasal tracheal intubation using Blind Intubation Device is safe and effective in anesthetized patients with Mallampati class 3

详细描述

The Blind Intubation Device (BID,Anhui Xiao Shan Hygienic Material Co.Ltd,Jixi County,China) is newly introduced for awake nasal intubation using a transillumination principle. For oral and maxillofacial surgery patients with anticipated difficult airways, the BID has a high rate of successful awake nasal intubation.Since the BID is more readily accessible,disposable and considerably less expensive,these advantages speak well for its use in China.However,to date,there is no study on its usage in anesthetized patients.The investigators hypothesized that a BID would be effective for nasal intubation in anesthetized patients with high Mallampati class and would result in fewer hemodynamic responses. To examine our hypothesis, the investigators would like to perform a prospective,randomized,controlled study to compare the effectiveness of the BID technique with a direct laryngoscope for nasal intubation in anesthetized patients with Mallampati class 3. The primary outcome measures are the hemodynamic changes during intubation. The investigators also would like to compare the intubation time required and associated airway complications in both groups as our second outcome.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status 1-2
  • Scheduled for oral and maxillofacial surgery under general anesthesia with nasotracheal intubation
  • mallampati score 3

排除标准

  • ASA physical status 3-4
  • Patients with a history of intraoral,upper airway and neck surgeries
  • Patients with a history of chronic respiratory, cardiovascular or any other systemic diseases
  • morbid obesity
  • neck scars
  • mallampati score 4,inter-incisor distance<3cm, thyromental distance<6cm
  • unstable cervical spine
  • relevant drug allergy

结局指标

主要结局

Hemodynamic changes

时间窗: 3 min after nasal intubation

hemodynamic changes

时间窗: 5 min from nasal intubation start

次要结局

  • intubation time required(0 min after nasal intubation)
  • immediate associated airway complications(5 min after nasal intubation)
  • 24h associated airway complications(24h after intubation)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other

研究点 (1)

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