Multicenter Assessment of the Ambu AuraGain Laryngeal Mask

Background: The new Ambu AuraGain is a second-generation supra-glottic airway device (SGAD) that combines the ability to evacuate gastric contents, deliver high seal pressure and facilitate tracheal intubation. However the evidence on its clinical use is limited. We are conducting a prospective observational study to assess the AuraGain performance in adult patients in 5 of Ambulatory Surgery Centers in Spain. 

Methods: Each local Ethics Committee approved the study. Exclusion criteria were: predicted difficult airway, high risk of regurgitation and morbid obesity. Expert investigators performed all insertions. Endpoints were success rate of insertion, time and number of insertion attempts, Oropharyngeal leak pressure (OLP), ventilation quality, ease of gastric tube passage and airway morbidity. A flexible scope was used to assess the anatomical alignment of the device with the larynx in 60 cases. Data was analyzed using the statistical software PASW Statistics 20.

Results: Data from 219 patients was analyzed. The median age was 52 ± 14 years, 52% were female and body mass index (IMC) was 26,5 ± 4,14 kg/m2. Overall success of insertion was 97% of the cases, with more than 85% succeeding at first attempt, and the median time to insertion was 21 ± 15 seconds, although, up to 60% of patients required additional maneuvers. Ventilation wasn’t optimal only in 2% of the patients. Persistent minor leaks were detected in two patients. The mean of seal pressure were 31 ± 7 and 33 ± 5 cm H2O for male and female, respectively. Insertion of a size 16 French gastric tube was easy in all cases. Endoscopic view showed complete vocal cords in 37 patients and non-obstructing epiglottis in 53. Severe complications rate were low.

Conclusions: This multicenter study suggest that, in expert hands, the Ambu AuraGain achieves a consistent high seal pressure resulting in an effective ventilation in most patients and provides an easy gastric access.  Success rate of insertion was high although adjusting maneuvers are frequently needed.

Multicenter assessment of the Ambu AuraGain laryngeal mask: preliminary results