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临床试验/NCT04566224
NCT04566224已完成不适用

Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial

Mackay Memorial Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Teeth trauma

研究概览

简要总结

Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the differences between Macintosh size 3 and 2 blades, we will analysis the data collected from airway and intubation condition.

详细描述

Selection the most appropriate size of laryngoscope blade size could not only increased intubation successful rate at the first time but also decrease the incidence of tissue trauma. Laryngoscope blade used in daily practice is usually Macintosh 3. However, compared with Caucasian people, Asian people are smaller and thinner especially in women. This study aims to confirm that the Macintosh 2 blade is not inferior to size 3 blade in laryngeal view and intubation rate.

Female patients without known difficult airway will be enrolled and allocated into Macintosh blade size 2 and size 3 groups. The age, body weight, body height, Mallampati classification, mouth opening, thyromental distance, neck circumference, intubation time, Cormack-Lehane grade, intubation difficulty scale scores and associated teeth or tissue traumas will be recorded.

研究设计

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

入排标准

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

入选标准

  • with American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
  • undergo elective surgery
  • receive endotracheal intubation

排除标准

  • with known difficult airway (i.e. pathology of the neck, upper airway or alimentary tracts)
  • with risks of pulmonary aspiration (i.e. emergent operation, pregnancy or inadequate nil per os)
  • with previous difficult intubation history
  • intubation attempts more than three times
  • patient refusal

结局指标

主要结局

Teeth trauma

时间窗: 0-10 minutes during induction

Any dental damage event related to intubation

Intubation difficulty scale scores

时间窗: 0-10 minutes during induction

Scoring system to assess the difficulty of intubation in each patient

Intubation time

时间窗: 0-10 minutes during induction

Time from laryngoscope insertion to the first adequate lung insufflation

Cormack-Lehane grade

时间窗: 0-10 minutes during induction

Classification of glottis view during intubation

Tissue trauma

时间窗: 0-10 minutes during induction

Any tissue trauma event related to intubation

次要结局

未报告次要终点

研究者

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

Ying-Chun Lin

attending physician, department of anesthesiology

Mackay Memorial Hospital

研究点 (1)

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