Different introducers are available to assist with tracheal intubation. Subtle differences in the design of introducers can have a marked effect on safety and performance. The Difficult Airway Society’s Airway Device Evaluation Project Team proposal states that devices should only be purchased for which there is at least a case–control study on patients assessing airway devices. However, resources are not currently available to carry out a case–control study on all introducers available on the market. This study comprised a laboratory and manikin-based investigation to identify introducers that could be suitable for clinical investigation. We included six different introducers in laboratory-based assessments (design characteristics) and manikin-based assessments involving the participation of 30 anaesthetists. Each anaesthetist attempted placement in the manikin’s trachea with each of the six introducers in a random order. Outcomes included first-time insertion success rate; insertion success rate; number of attempts; time to placement; and distance placed. Each anaesthetist also completed a questionnaire. First-time insertion success rate depended significantly on the introducer used (p = 0.0016) and varied from 47% (Armstrong and P3) to 77% (Intersurgical and Frova). Median time to placement (including oesophageal placement) varied from 10 s (Eschmann and Frova) to 20 s (P3) (p = 0.0025). Median time to successful placement in the trachea varied from 9 s (Frova) to 22 s (Armstrong) (p = 0.037). We found that the Armstrong and P3 devices were not as acceptable as other introducers and, without significant improvements to their design and characteristics, the use of these devices in studies on patients is questionable. The study protocol is suitable for differentiating between different introducers and could be used as a basis for assessing other types of devices.

中文翻译：

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用于气道管理的引入器的评估

不同的导引器可用于协助气管插管。引入器设计的细微差异会对安全性和性能产生显着影响。困难气道协会的气道设备评估项目小组提案指出，仅应购买至少对评估气道设备的患者进行病例对照研究的设备。然而，目前没有资源可用于对市场上所有可用的介绍人进行病例对照研究。这项研究包括实验室和基于人体模型的调查，以确定可能适合临床调查的介绍人。我们在基于实验室的评估（设计特征）和基于人体模型的评估中纳入了 6 个不同的介绍人，涉及 30 名麻醉师的参与。每个麻醉师都尝试将六个引入器中的每一个以随机顺序放置在人体模型的气管中。结果包括首次插入成功率；插入成功率；尝试次数; 安置时间；和放置的距离。每位麻醉师还完成了一份问卷调查。首次插入成功率显着取决于所使用的引入器 (p = 0.0016)，从 47%（Armstrong 和 P3）到 77%（Intersurgical 和 Frova）不等。中位放置时间（包括食管放置）从 10 秒（Eschmann 和 Frova）到 20 秒（P3）不等（p = 0.0025）。成功置入气管的中位时间从 9 秒（Frova）到 22 秒（Armstrong）不等（p = 0.037）。我们发现 Armstrong 和 P3 设备不如其他介绍人可接受，并且，如果不对它们的设计和特性进行重大改进，那么在对患者的研究中使用这些设备是值得怀疑的。该研究方案适用于区分不同的介绍人，并可用作评估其他类型设备的基础。