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

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.