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临床试验/NCT05522049
NCT05522049已完成不适用

Videolaryngoscopy-guided Intubation Using Macintosh Versus Hyperangulated Blades in Patients With Expected Difficult Intubation Undergoing Ear, Nose and Throat Surgery or Maxillofacial Surgery a Randomized Controlled Trial

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2022年10月17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
182
试验地点
2
主要终点
Percentage of glottic opening (POGO)

研究概览

简要总结

Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery
  • Expected difficult intubation

排除标准

  • Pregnant or breastfeeding woman
  • Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents)
  • Required transnasal tracheal intubation (e.g. for surgical reasons)
  • Special tubes required for surgical reasons ( e.g. double lumen tube)
  • Denial of consent

结局指标

主要结局

Percentage of glottic opening (POGO)

时间窗: 1 hour

Grading of the best view obtained during laryngoscopy (%)

次要结局

  • Time to successful first attempt intubation (seconds)(1 hour)
  • Impaired view (vocal cords cannot be visualized by laryngoscopy)(1 hour)
  • Cormack-Lehane grade(1 hour)
  • Transition to a different tracheal intubation technique(1 hour)
  • Overall success of intubation(1 hour)
  • Difficulty of videolaryngoscope-guided intubation(1 hour)
  • Hypoxaemia(1 hour)
  • Time to successful tracheal intubation (seconds)(1 hour)
  • Tracheal introducer(1 hour)
  • Number of intubation attempts(1 hour)
  • Difficult laryngoscopy(1 hour)
  • Difficult intubation(1 hour)
  • Successful first attempt(1 hour)
  • Number of laryngoscopy attempts(1 hour)
  • Airway related adverse events(1 hour)
  • Hypotension(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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