Yahaya Zanahriah, Teoh Wendy H, Dintan Nora A, Agrawal Ravi
Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore.
Private Anaesthesia Practice, Wendy Teoh Pte. Ltd., Singapore.
Anesthesiol Res Pract. 2016;2016:4717061. doi: 10.1155/2016/4717061. Epub 2016 Oct 25.
. Manikin studies' data cannot accurately be extrapolated to real-life scenarios and inherent differences in design and materials of newer products may affect their clinical performance. . Hence, we compared the AMBU® Aura-i™ and LMA Supreme™ in this randomized trial involving 100 ASA 1-2 unparalysed anaesthetised patients undergoing minor gynaecological surgery. Investigators had <20 Aura-i insertions. Primary outcome was time to achieve effective ventilation and secondarily insertion parameters, oropharyngeal leak pressures (OLP), fibreoptic positioning, and pharyngeal morbidity. The position of the Ambu Aura-i was evaluated with the Ascope; the fiberoptic view of the glottis was scored on a five-point scale. . 43 (86%) AMBU Aura-i and 44 (88%) LMA Supremes were successfully inserted on first attempt ( = 0.59), with similar ease ( = 0.79), and comparable times to first capnogram, mean (SD) 18.2 (6.0) versus 17.3 (6.4) sec, = 0.9. The Aura-i needed significantly less volume of air to inflate its cuff to 60 cmHO on the manometer, 17.7 (3.5) versus 23.1 (4.4) mL, < 0.001. Both devices exhibited similar OLP, Aura-i versus LMA Supreme, mean (SD) 28.8 (7.1) versus 27.3 (5.3) cmHO, = 0.24. There was no difference in ease of insertion or adjustment manoeuvres to aid ventilation. 90% of patients had good positioning of Aura-i on fibreoptic check, yielding a view of the vocal cords and epiglottis. In 5 patients (10%), the vocal cords were not seen, but ventilatory function was unaffected. . The Aura-i handled well in novices hands, with comparable times to insert and establish ventilation, similar leak pressures, and successful first attempt insertion rates compared to the LMA Supreme.
人体模型研究的数据无法准确外推至实际临床场景,新产品在设计和材料上的固有差异可能会影响其临床性能。因此,我们在这项随机试验中对AMBU® Aura-i™和LMA Supreme™进行了比较,该试验纳入了100例接受小型妇科手术、美国麻醉医师协会(ASA)分级为1-2级且未使用肌肉松弛剂的麻醉患者。研究人员操作Aura-i的经验少于20次。主要结局指标为实现有效通气的时间,次要结局指标为插入参数、口咽漏气压(OLP)、纤维喉镜定位以及咽部并发症。使用Ascope评估Ambu Aura-i的位置;声门的纤维喉镜视野按五分制评分。43例(86%)AMBU Aura-i和44例(88%)LMA Supreme首次尝试即成功插入(P = 0.59),插入难度相似(P = 0.79),首次出现呼气末二氧化碳波形的时间相当,平均(标准差)分别为18.2(6.0)秒和17.3(6.4)秒,P = 0.9。在人体模型上,将Aura-i的套囊充气至压力计显示60 cmH₂O时所需的空气量显著更少,分别为17.7(3.5)毫升和23.1(4.4)毫升,P < 0.001。两种装置的OLP相似,Aura-i与LMA Supreme相比,平均(标准差)分别为28.8(7.1)cmH₂O和27.3(5.3)cmH₂O,P = 0.24。在辅助通气的插入或调整操作的难易程度上没有差异。纤维喉镜检查时,90%的患者Aura-i定位良好,可看到声带和声门。5例患者(10%)未看到声带,但通气功能未受影响。与LMA Supreme相比,新手操作Aura-i时效果良好,插入并建立通气的时间相当,漏气压相似,首次尝试插入成功率也相似。