BACKGROUND: Supraglottic airway devices are commonly used in general anaesthesia in children. The AuraGain is a newly developed disposable second-generation supraglottic airway device with an inflatable cuff and a gastric port. OBJECTIVE: To confirm our hypothesis that the oropharyngeal leak pressure (OLP) of the AuraGain would be noninferior to that of the i-gel in paediatric patients. DESIGN: A single-blinded, randomised, noninferiority, clinical trial. SETTING: Single-centre trial from January to March 2017. PATIENTS: One hundred paediatric patients (American Society of Anesthesiologists' physical status 1 to 3), aged up to 12 years old, and body weight of 5 to 30 kg requiring a supraglottic airway for elective surgery with an expected surgery time of less than 2 h under general anaesthesia. INTERVENTION: The patients were randomised to allocation to the AuraGain group or the i-gel group. The device size (1.5 to 2.5) used in each group was based on the manufacturer's recommendation. MAIN OUTCOME MEASURES: The primary outcome measure was OLP immediately after insertion, with a predefined noninferiority margin of 3 cmH2O. RESULTS: The OLP immediately after insertion was lower for the AuraGain than for the i-gel (17.1 vs. 23.0 cmH2O; mean difference: -5.9 cmH2O; 95% confidence interval: -8.5 to -3.3 cmH2O; P = 0.98 and <0.001 for noninferiority and superiority, respectively). The first-attempt success rate (AuraGain, 96% vs. i-gel, 90%; P = 0.44) was comparable between the devices. The incidence of blood staining was lower (AuraGain, 6% vs. i-gel, 0%; P = 0.012) and time to insertion was shorter (AuraGain 21.3 vs. i-gel, 17.1 s; P < 0.001) for the i-gel compared with the AuraGain. CONCLUSION: Our noninferiority hypothesis was not adopted. The OLP of the i-gel may be higher than that of the AuraGain, but this superiority hypothesis should be investigated in future trials. The i-gel demonstrated a shorter time to successful placement and lower incidence of blood staining than the AuraGain. TRIAL REGISTRATION: University Hospital Medical Information Network identifier, UMIN000024222.
RCT Entities:
BACKGROUND: Supraglottic airway devices are commonly used in general anaesthesia in children. The AuraGain is a newly developed disposable second-generation supraglottic airway device with an inflatable cuff and a gastric port. OBJECTIVE: To confirm our hypothesis that the oropharyngeal leak pressure (OLP) of the AuraGain would be noninferior to that of the i-gel in paediatric patients. DESIGN: A single-blinded, randomised, noninferiority, clinical trial. SETTING: Single-centre trial from January to March 2017. PATIENTS: One hundred paediatric patients (American Society of Anesthesiologists' physical status 1 to 3), aged up to 12 years old, and body weight of 5 to 30 kg requiring a supraglottic airway for elective surgery with an expected surgery time of less than 2 h under general anaesthesia. INTERVENTION: The patients were randomised to allocation to the AuraGain group or the i-gel group. The device size (1.5 to 2.5) used in each group was based on the manufacturer's recommendation. MAIN OUTCOME MEASURES: The primary outcome measure was OLP immediately after insertion, with a predefined noninferiority margin of 3 cmH2O. RESULTS: The OLP immediately after insertion was lower for the AuraGain than for the i-gel (17.1 vs. 23.0 cmH2O; mean difference: -5.9 cmH2O; 95% confidence interval: -8.5 to -3.3 cmH2O; P = 0.98 and <0.001 for noninferiority and superiority, respectively). The first-attempt success rate (AuraGain, 96% vs. i-gel, 90%; P = 0.44) was comparable between the devices. The incidence of blood staining was lower (AuraGain, 6% vs. i-gel, 0%; P = 0.012) and time to insertion was shorter (AuraGain 21.3 vs. i-gel, 17.1 s; P < 0.001) for the i-gel compared with the AuraGain. CONCLUSION: Our noninferiority hypothesis was not adopted. The OLP of the i-gel may be higher than that of the AuraGain, but this superiority hypothesis should be investigated in future trials. The i-gel demonstrated a shorter time to successful placement and lower incidence of blood staining than the AuraGain. TRIAL REGISTRATION: University Hospital Medical Information Network identifier, UMIN000024222.