Comparison of the clinical performance of the Ambu®AuraGain™ laryngeal mask in children undergoing surgery in the supine and prone position - A prospective, non-inferiority clinical trial.

STUDY OBJECTIVE

Reports are limited regarding supraglottic airway (SGA) usage in children in the prone position. This study aimed to compare the clinical performance of the Ambu®AuraGain™, a 2nd generation SGA, in children undergoing surgery in the prone and supine positions. We hypothesized that oropharyngeal leak pressure (OLP) in the prone position would not be inferior to that in the supine position.

DESIGN

Single-center, prospective, non-randomized controlled study.

SETTING

Operating room.

PATIENTS

One hundred and twenty-six children, American Society of Anesthesiologists (ASA) physical status I-III, aged 2-12 years, undergoing elective surgery for 2 h or less in the supine or prone position.

INTERVENTIONS

After induction of general anesthesia and insertion of the AuraGain, patients were positioned either supine or prone, according to type of surgery.

MEASUREMENTS

OLP immediately after surgical positioning was measured as the primary outcome. The anatomical position of the AuraGain was evaluated using a flexible fiberoptic bronchoscope (Olympus LF-DP Tracheal Intubation Fiberscope, Melville, New York, USA). Airway maneuvers performed during placement and maintenance of the AuraGain and airway-related adverse events were recorded.

MAIN FINDINGS

The mean difference in OLP immediately after positioning was 0.048 cmHO (95 % confidence interval: -1.521 to 1.616), and the non-inferiority hypothesis was accepted (P < 0.001 for non-inferiority). There was no significant difference in the anatomical position of the SGA and adverse events. Airway maneuvers were significantly more commonly performed during placement in the Prone group compared to the Supine group (51 (81.0 %) vs. 3 (4.8 %), respectively; P < 0.001).

CONCLUSION

OLP when using AuraGain in the prone position in children was not inferior to that in the supine position. This suggests that the AuraGain may be an effective option for children undergoing short surgical procedures in the prone position.