Oropharyngeal leak pressure of the Ambu® AuraGain™ versus Flexicare® LarySeal™ Pro in ophthalmic surgery: a randomized controlled trial

BACKGROUND: Laryngeal mask airways are commonly used for airway management during general anesthesia. Although numerous second-generation devices have been extensively evaluated, clinical comparisons for others remain limited. While the Flexicare® LarySeal™ Pro has been assessed in ophthalmologic surgery, no direct comparison with the Ambu® AuraGain™ has yet been conducted. This study aimed to compare the LarySeal™ Pro and the AuraGain™ in patients undergoing ophthalmologic surgery under general anesthesia.METHODS: In this single-center, randomized, single-blinded trial, 178 patients scheduled for ophthalmologic surgery were assigned to receive either the LarySeal™ Pro or the AuraGain™. The primary endpoint was oropharyngeal leak pressure. Secondary endpoints included success on first insertion attempt, number of attempts, insertion time, subjective difficulty, and need for replacement. Insertion-related adverse events were recorded.RESULTS: Of 178 randomized participants, 146 data sets were analyzed (AuraGain™: 76; LarySeal™ Pro: 70). Groups were demographically comparable. Oropharyngeal leak pressure was significantly higher with AuraGain™ (median 40.8 vs. 33.2 cmH2O; P=0.049; per-protocol: 40.8 vs. 30.6 cmH2O; P=0.035). First-attempt success was more frequent with AuraGain™ (84.2% vs. 60.1%; P=0.001), and fewer attempts were required for successful placement (P=0.023). Insertion time and subjective difficulty did not differ. A subsequent device change was more often necessary with the LarySeal™ Pro (33.8% vs. 8.5%; P<0.001). No significant differences in adverse events were observed.CONCLUSIONS: In patients undergoing ophthalmologic surgery, the AuraGain™ demonstrated a significantly higher oropharyngeal leak pressure and a more favorable performance than the LarySeal™ Pro. No safety concerns were observed with either device.