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临床试验/NCT01691703
NCT01691703已完成不适用

Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation

Catharina Ziekenhuis Eindhoven2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年8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
40
试验地点
2
主要终点
Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.

研究概览

简要总结

A difficult tracheal intubation can be a problem, even if one has taken all precautions. A possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation scope. As such, the videolaryngoscope can be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.

详细描述

In this blinded, unrandomised trial the investigators would like to investigate the change in Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to record the success of intubation and the time needed until successful endotracheal intubation when using this technique as well as complications (trauma to the oral cavity, dental trauma, and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at the end of the procedure will be noted and adjuncts that are used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
Single (Outcomes Assessor)

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

  • Informed patient consent Age > 18 years History of difficult intubation (Cormack and Lehane III-IV)
  • One or more predictors of a difficult intubation:
  • restricted neck movement
  • thyromental distance < 60 mm
  • interincisor/interdental distance < 30mm
  • BMI > 35 kg.m-2 Elective surgery making endotracheal intubation necessary (other than head and/or neck surgery) Fasted (≥ 6 hours)

排除标准

  • No informed patient consent Age < 18 years Emergency surgery, head and/or neck surgery Fasted < 6 hours

结局指标

主要结局

Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.

时间窗: The patients will be followed during induction of anesthesia, an average of 10 minutes

The operator will score these grades during the process of intubation. Pictures will be taken of the first and the second Cormack and Lehane grade, and these pictures will later be scored by two anaesthesiologists, blinded for the technique used (videolaryngoscopy alone or videolaryngoscopy combined with the Bonfils®).

次要结局

  • Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.(The patients will be followed during induction of anesthesia, an average of 10 minutes)
  • Time until successful endotracheal intubation(The patients will be followed during induction of anesthesia, an average of maximal 3 minutes)
  • Complications rendered on during the procedure(The patients will be followed during induction of anesthesia, an average of 10 minutes)
  • Adjuncts being used(The patients will be followed during induction of anesthesia, an average of 10 minutes)

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbe Pieters

MD

Catharina Ziekenhuis Eindhoven

研究点 (2)

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