Oropharyngeal airways are used both to facilitate airway patency during mask ventilation as well as conduits for flexible scope intubation, though none excel at both. A novel device, the Articulated Oral Airway (AOA), is designed to facilitate flexible scope intubation by active displacement of the tongue. Whether this active tongue displacement also facilitates mask ventilation, thus adding dual functionality, is unknown. This study compared the AOA to the Guedel Oral Airway (GOA) in regards to efficacy of mask ventilation of patients with factors predictive of difficult mask ventilation. The hypothesis was that the AOA would be non-inferior to the GOA in terms of expiratory tidal volumes by a margin of 1 ml/kg, thus demonstrating dual functionality. In this randomized controlled clinical trial, fifty-eight patients with factors predictive of difficult mask ventilation were mask ventilated with both the GOA and the AOA. Video of the anesthetic monitors were evaluated by a blinded member of the research team, noting inspiratory and expiratory tidal volumes and expiratory CO2 waveforms. The AOA was found to be non-inferior to the GOA at a margin of 1 ml/kg with a mean weight-standardized expiratory tidal measurement 0.45 ml/kg lower (CI: 0.34–0.57) and inspiratory tidal measurement 0.109 lower (CI: − 0.26-0.04). There was no significant difference in expiratory waveforms (p = 0.2639). The AOA was non-inferior to the GOA for mask ventilation of patients with predictors of difficult mask ventilation and there was no significant difference in EtCO2 waveforms between the groups. These results were consistent in the subset of patients who were initially difficult to mask ventilate. ClinicalTrials.gov, NCT03144089 , May 2017.

中文翻译：

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铰接式口腔气道作为面罩通气的辅助手段：一项前瞻性、随机、干预性、非劣效性研究

口咽气道既可用于在面罩通气期间促进气道通畅，也可用于柔性内窥镜插管，但两者都不擅长。一种新型装置，铰接式口腔气道 (AOA)，旨在通过主动移动舌头来促进灵活的内窥镜插管。这种主动舌位移是否也有助于面罩通气，从而增加双重功能，尚不清楚。本研究将 AOA 与 Guedel Oral Airway (GOA) 比较了面罩通气对具有预测面罩通气困难的因素的患者的效果。假设是 AOA 在呼气潮气量方面不劣于 GOA 1 ml/kg，从而证明了双重功能。在这项随机对照临床试验中，58 名具有预测面罩通气困难因素的患者同时使用 GOA 和 AOA 进行面罩通气。麻醉监测器的视频由研究小组的一名盲人成员评估，记录吸气和呼气潮气量以及呼气 CO2 波形。发现 AOA 不劣于 GOA，边界为 1 ml/kg，平均体重标准化呼气潮汐测量值低 0.45 ml/kg（CI：0.34–0.57），吸气潮气测量值低 0.109（CI： - 0.26-0.04)。呼气波形没有显着差异（p = 0.2639）。对于具有困难面罩通气预测因素的患者的面罩通气，AOA 不劣于 GOA，并且各组之间的 EtCO2 波形没有显着差异。这些结果在最初难以进行面罩通气的患者亚组中是一致的。ClinicalTrials.gov，NCT03144089，2017 年 5 月。