Efficacy and safety of three inflation methods of the laryngeal mask airway Ambu® Auraonce™: a randomized controlled study.

The laryngeal mask airway (LMA) is commonly used for airway management. Cuff hyperinflation has been associated with complications, poor ventilation and increased risk of gastric insufflation. This study was designed to determine the best cuff inflation method of AuraOnce™ LMA during bronchoscopy and EBUS (Endobronquial Ultrasound Bronchoscopy) procedure. We designed a Randomized controlled, doble-blind, clinical trial to compare the efficacy and safety of three cuff inflation methods of AuraOnce™ LMA. 210 consenting patients scheduled for EBUS procedure under general anesthesia, using AuraOnce™ LMA were randomized into three groups depending on cuff insufflation: residual volume (RV), half of the maximum volume (MV), unchanged volume (NV). Parameters regarding intracuff pressure (IP), airway leak pressure (OLP), leakage volume (LV) were assessed, as well as postoperative complications (PC). 201 (95.7%) patients completed the study. Mean IP differed between groups (MV: 59.4 ± 32.4 cm HO; RV: 75.1 ± 21.1 cm HO; NV: 83.1 ± 25.5 cmH0; P < 0.01). The incidence of IP > 60 cmHO was lower in the MV group compared to the other two (MV: 20/65(30.8%); RV:47/69 (68.1%); NV 48/67 (71.6%); p < 0.01). The insertion success rate was 89,6% (180/201) at first attempt, with no difference between groups (p = 0.38). No difference between groups was found either for OLP (p = 0.53), LV (p = 0.26) and PC (p = 0.16). When a cuff manometer is not available, a partial inflation of AuraOnce™ LMA cuff using MV method allows to control intracuff pressure, with no significant changes of OLP and LV compared to RV and NV insufflation method.Registration clinical trial: NCT04769791.