Comparison of laryngeal mask airway supremeTM as non-inflatable cuff device and self-pressurized air-QTM in children: Randomized controlled non-inferiority study.

Abstract

Background: Supraglottic airway (SGA) device with non-inflatable cuff reduce the airway complications associated with cuff hyperinflation. The aim of the study is to determine whether the default setting of Supreme is as effective as the non-inflatable cuff devices. The oropharyngeal leak pressure was measured and compared between the Supreme and Air-Q, a typical non-inflatable cuff device. We hypothesized that the default setting of Supreme is non-inferior to the the Air-Q self-pressurized (SP) in respect to the oropharyngeal leak pressure.Methods: Eighty-four patients aged 1 to 7 years who were scheduled for general anesthesia, participated in the study. The patients were randomly assigned to Supreme group (n = 41) or Air-Q SP group (n = 43). We considered that the primary outcome, oropharyngeal leak pressure of Supreme group would be non-inferior to the Air-Q SP group, within 3 cmH2O. Other outcomes included tidal volume loss, difficulty of insertion, insertion time, and complications.Results: The oropharyngeal leak pressure of the Supreme and Air-Q SP was 19.9 ± 4.1 cm H2O and 17.4 ± 2.9 cm H2O, respectively. The mean differences of 2 devices (Air-Q SP—Supreme) were −2.5 cm H2O, (95% confidence interval [−4.0 to −0.9], P = .002). The upper CI was smaller than the non-inferiorty margin (3 cm H2O). This result suggested that the default setting of Supreme was superior to the Air-Q SP with respect to the oropharyngeal leak pressure. However, there were no significant differences in tidal volume loss over time, ease of device insertion score, insertion time, and complications.Conclusions: The Supreme can be used in the default setting in pediatric patients accordingly in terms of tolerable leak pressure and the stability for mechanical ventilation compared with Air-Q SP.