A prospective, randomized trial of the Ambu AuraGain™ laryngeal mask versus the LMA® protector airway in paralyzed, anesthetized adult men

BACKGROUND: We hypothesize that oropharyngeal leak pressures differ between the LMA (R) Protector (TM) and the AuraGain (TM), two novel supraglottic airway devices offering the possibility of intubation. METHODS: Ninety-eight male patients ASAI-II were randomly assigned to the AuraGain (TM) or Protector (TM) group. Oropharyngeal leak pressure was measured by incrementing cuff volume in 10 mL steps from 10 mL to 40 mL. The primary outcome was oropharyngeal leak pressure at 40 mL cuff volume. Secondary parameters such as transdevice intubation success, intubation time, the number of intubation attempts, and resistance during advancement of the endotracheal tube were determined. RESULTS: Mean (SD) oropharyngeal leak pressures at cuff volume of 40 mL was 30.1 (6) cmH(2)O for the AuraGain (TM) and 28.2 (7) cmH(2)O for the LMA Protector (TM) (P=0.142). The mean intracuff pressure for the AuraGain (TM) was 154 (41) cmH(2)O and 200 (43) cmH(2)O for the LMA Protector (P <= 0.001). The number of attempts to insert the laryngeal mask was higher for the AuraGain (TM) group (P=0.002). Intubation time was lower in the AuraGain (TM) group (15.7 s vs. 18.5 s [Protector (TM) group]; P=0.004), and less resistance in advancing the tracheal tube through the AuraGain (TM) compared to LMA Protector (TM) device (P<0.001). There were no differences in fiberoptic placement of the endotracheal tube, the number of intubation attempts or postoperative morbidity between the groups. CONCLUSIONS: Because of the higher success rate in first time insertion of the laryngeal mask and the gastric tube, respectively, as well as the lower resistance to insertion of the endotracheal tube we conclude a possible easier handling of the AuraGain (TM) in anesthetized male patients.