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临床试验/NCT02640196
NCT02640196已完成不适用

A Comparison of Three Videolaryngoscopes for Double-lumen Tubes Intubation in Simulated Easy and Difficult Airways

Imam Abdulrahman Bin Faisal University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Time to achieve successful double lumen tube intubation

研究概览

简要总结

The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. The investigators have considered to assess the efficacy of each device in manikins before considering to evaluate them in patients undergoing thoracic procedures.

Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT intubation participated in this randomised crossover study. Following a brief demonstration and two practice attempts, participants were volunteered to insert a DLT using the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an attempt took longer than 150 seconds, were recorded.

详细描述

Several regional surveys demonstrated that most thoracic anesthesiologists are using the double-lumen endobronchial tubes (DLT) as the first-choice lung separation technique. DLT, when compared with single lumen tracheal tube, can be more difficult to insert in patients with difficult airways. The videolaryngoscopes (VL) have the potential to facilitate the placement of the DLTs for lung separation in patients with predicted or unanticipated difficult airway.

The use of GlideScope® (Verathon Inc., Bothell, WA, USA), a VL with an angulated blade, has been associated with variable times to DLT intubation according to the prior experience of the operators, despite superior visualization of the glottis The channeled Airtraq® (Prodol Meditec S.A., Vizcaya, Spain) and standard non-channeled blade of the King Vision™ (Ambu, Ballerup, Copenhagen, Denmark), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT. Of note, the longer times to DLT intubation with the use of different VL could be shortened with building up the operator's experience.

To the best of the investigators knowledge, the comparison of the effects of the Macintosh, GlideScope®, Airtraq®, and King Vision™ VL on the time to DLT intubation in simulated easy and difficult airways has not yet been studied.

Two high-fidelity simulators (Airway Management Trainer, model AA-3100, Laerdal, Kent, UK) were prepared to simulate easy and difficult airway situations, as described by Marshall et al. and Wang et al. The "easy" airway was established with the manikin in a neutral position. The "difficult" airway setting was obtained by placing an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA) under the occiput and securing the head position with adhesive tape, object to replicate cervical-collar use. Positioning was confirmed after each attempt to ensure consistency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

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

入选标准

  • Staff anesthesiologists
  • Signed consent
  • Limited experience in using videolaryngoscopes for inserting double lumen tubes

排除标准

  • Decline to sign the consent
  • Non receiving the prior training demonstration
  • Non practicing once with each device tested on each simulator scenario

结局指标

主要结局

Time to achieve successful double lumen tube intubation

时间窗: for 6 min after using each device

defined as the time when the investigated laryngoscope passed the central incisors to when the tip of the bronchial lumen passed through the glottis, as confirmed visually by the operator (in the Macintosh group) or by the investigator, thanks to remote screens (in the VLs groups).

次要结局

  • Best view during laryngoscopy using the classification described by Cormack and Lehane(for 1 min after laryngoscopy)
  • Difficulty of intubation using a Visual Analog Scale (VAS)(for 6 min after using each device)
  • Number of first-pass success(for 3 min after using each device)
  • Number of the required optimisation manoeuvers(for 6 min after using each device)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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