A Randomized Trial Comparing the Ambu® Aura-i™ and the Ambu® Aura Gain™ Laryngeal Mask As Conduit for Tracheal Intubation in Children

Background: The Ambu Aura Gain is a newer second-generation supraglottic airway device designed for fibreoptic bronchoscopy (FOB)-guided tracheal intubation.

Methods: 57 patients between 18 months and six years of age were randomized to receive either the Ambu Aura-I (N.=29) or the Ambu Aura Gain (N.=28). Primary endpoint was the time for intubation. Secondary endpoints were the time and number of attempts for device insertion, the feasibility of FOB-guided intubation, the oropharyngeal leak pressure (OLP) the fibreoptic grade of laryngeal view and possible complications.

Results: No difference was found in the time for intubation, the time for device insertion or the fibreoptic grade of laryngeal view. First-attempt device insertion was successful in all (N.=28) patients with Aura Gain (100%) and in 27 (97%) with Aura-i. In the Aura-i group one insertion failed. A significant difference in successful intubation was seen between the Aura-i and the Aura Gain (79% vs. 100%, respectively, P=0.0011). Also found was a significant difference in the mean OLP (SD) between the Ambu Aura-i and the Ambu Aura Gain (18 [3] vs. 20 [3] cmH<inf>2</inf>O, respectively; mean difference [MD] 2 cmH<inf>2</inf>O; P=0.005).

Conclusions: The Ambu Aura Gain served as a reliable device for FOB-guided tracheal intubation. Even if the time for intubation, when intubation was possible did not differ, the Aura-i showed only 79% intubation success, making it a doubtful device for FOB-guided tracheal intubation in cases of emergency and severe hypoxemia in small children.