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临床试验/NCT03226002
NCT03226002已完成不适用

Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial

Kocaeli University2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2017年4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
35
试验地点
2
主要终点
insertion time of the device

研究概览

简要总结

After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay aimed to compare the glottis visualization time, intubation time and total intubation times.

详细描述

After Ethics committee approval, investigators decided to enroll 40 pateints ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. In addition is the 90° anti-clockwise rotation of the tip of the tube helpful to insert the tube into the trachea. Patients were randomized into right and the left nostril groups. After standard anesthesia induction with propofol and fentanyl, rocuronium was used for muscle relaxation. Primary aim of this prospective study was to compare the glottis visualization time, intubation time and total intubation times. The Cormack-Lehane grades, the need for optimization, tube adjustment maneuvers, hemodynamic data, occurrence of epistaxis of the patients were recorded during the process.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years of age
  • undergoing elective maxillofacial surgery
  • dental surgery
  • plastic surgery requiring nasotracheal intubation

排除标准

  • >18 years and > 65 years
  • ASA III-IV
  • fasted patients
  • patients do not require nasotracheal intubation

结局指标

主要结局

insertion time of the device

时间窗: 20 seconds

handling the device till the optimal glottis visualization occurred

nasotracheal intubation time with the device

时间窗: 30 seconds

handling the device till the visualization of tracheal tube through the vocal cords

total nasotracheal intubation time with the device

时间窗: 40 seconds

handling the device till the confirmation of nasotracheal intubation with end-tidal carbodioxide

次要结局

  • minor complications related to the device(40 seconds)
  • optimisation maneuvers during intubation with the device(20 seconds)

研究者

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

Zehra Ipek ARSLAN

Assistant professor

Kocaeli University

研究点 (2)

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