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] cmH2O, respectively; mean difference [MD] 2 cmH2O; 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.