Randomised comparison of the clinical performance of Ambu Auragain and Teleflex LMA Protector

This study was designed as a prospective randomised clinical study comparing two supraglottic airway (SGA) devices, the Ambu Auragain and the Teleflex LMA Protector, in elective patients with normal airway anatomy. Device characteristics evaluated were SGA insertion, functionality of SGA as a ventilatory device and as an intubation conduit, functionality of the gastric drainage channel, and oropharyngeal leak pressure (OLP). Additionally, a fibreoptic assessment, utilising the Ambu aScope 3 Slim, of the glottic view via the SGA device and signs of airway morbidity were investigated. The primary outcome was successful SGA insertion on first attempt, whereas secondary aims were SGA insertion time, number of insertion attempts, ease of SGA insertion, rate of successful ventilation and intubation (by using the SGA as an intubation conduit), anatomical fit of SGA (displacement, bloodstaining), and fibreoptic assessment of the glottic view via the SGA device. Patients included in this study were adult surgical candidates, ASA 1–3, age >18 yr, Mallampati I–III, BMI ≤ 30 kg m–2. The exclusion criteria included: ASA 4–5, age <18 yr, surgery in the prone position, planned operating time >4 h, high risk of regurgitation, exhibition of respiratory tract pathology, or preoperative sore throat. Once informed consent was obtained (IRB #2017-0449), the randomisation process was performed using an institutional software, CORe (Clinical Oncology Research System). In total, 53 patients were included in this study. The overall success rate of device insertion on the first attempt was 92%. The success rate was higher in the Ambu Auragain group than in the LMA Protector group (96% vs 88%, respectively; difference=0.09; 95% confidence interval [CI] [–0.06, 0.23]; P = 0.260). All patients in the Ambu Auragain group exhibited a POGO score of 100%, whereas patients in the LMA Protector group achieved a POGO score of 83% (P = 0.046 Fisher's exact test). There was no significant difference in the time to place the tracheal tube (∼90 s for both groups) or reported ease of use. Passage of a 16F gastric tube was significantly easier in the Ambu Auragain group (P=0.01; 100% vs 86% in LMA Protector group); there were six failures and one gastric tube passage with resistance in the LMA Protector group. This study showed that both the Ambu Auragain and the LMA Protector have a high successful first attempt placement success rate. In general, the Ambu Auragain had better performance scores and fewer adverse events, as compared with the LMA Protector. Future study is warranted in a larger patient population and in patients at higher risk for difficult airway management.