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临床试验/NCT02897518
NCT02897518已完成不适用

Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study

Federico II University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年1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
45
试验地点
2
主要终点
feasibility of endotracheal intubation

研究概览

简要总结

The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®.

Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm, mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 77 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>18 years
  • Mallampati class 3-4
  • inter-incisor distance < 30 mm
  • mental-thyroidal distance < 60 mm
  • large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility
  • reduced mental-jugular distance.

排除标准

  • < 1 criteria for predicted difficult airway
  • emergency surgery
  • age < 18 years
  • declined consent to participate

结局指标

主要结局

feasibility of endotracheal intubation

时间窗: within 60 seconds

次要结局

  • Cormack and Lehane score view(During endotracheal intubation)
  • use of adjunctive maneuvers to aid the endotracheal intubation(During endotracheal intubation)
  • Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope(wthin 120 seconds)
  • Intubation difficulty scale score(within 60 seconds)
  • Intubation time(wthin 120 seconds)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Vargas

MD

Federico II University

研究点 (2)

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