BACKGROUND: This prospective, randomized, controlled trial compares the performance of the pediatric i-gel (Intersurgical Ltd., Wokingham, United Kingdom) with the Ambu AuraOnce laryngeal mask (Ambu A/S, Ballerup, Denmark) in anesthetized and ventilated children. METHODS: With ethics committee approval and written informed consent, the authors included 208 children, aged 0-17 yr, scheduled for elective day-surgery under general anesthesia. The primary outcome variable was oropharyngeal leak pressure. Other outcome variables were first-attempt and overall success, time to sufficient ventilation, and adverse events. RESULTS: Demographic data did not differ between groups. The leak pressure of the i-gel was significantly higher than the leak pressure of the Ambu (mean ± SD: 22 ± 5 cm H₂O vs. 19 ± 3, P < 0.01). First-attempt success was 91% for the i-gel and 93% for the Ambu (P = 0.50). Overall success was 93% for the i-gel versus 98% for the Ambu (P = 0.10). Successfully inserted i-gels needed to be secured by taping in place to ensure the seal in 44% (0% with the Ambu, P < 0.01). Insertion was faster with the Ambu (24 ± 8 s vs. 27 ± 11, P = 0.02). There were no major side effects with either device. CONCLUSIONS: The leak pressure of the i-gel was statistically but not clinically significantly higher than the leak pressure of the Ambu. Time to insertion was longer with the i-gel. Both airway devices are suitable for positive pressure ventilation with high success rates in infants and children. Because the i-gel is prone to sliding out, it must be taped in place to avoid loss of the airway.
RCT Entities:
BACKGROUND: This prospective, randomized, controlled trial compares the performance of the pediatric i-gel (Intersurgical Ltd., Wokingham, United Kingdom) with the Ambu AuraOnce laryngeal mask (Ambu A/S, Ballerup, Denmark) in anesthetized and ventilated children. METHODS: With ethics committee approval and written informed consent, the authors included 208 children, aged 0-17 yr, scheduled for elective day-surgery under general anesthesia. The primary outcome variable was oropharyngeal leak pressure. Other outcome variables were first-attempt and overall success, time to sufficient ventilation, and adverse events. RESULTS: Demographic data did not differ between groups. The leak pressure of the i-gel was significantly higher than the leak pressure of the Ambu (mean ± SD: 22 ± 5 cm H₂O vs. 19 ± 3, P < 0.01). First-attempt success was 91% for the i-gel and 93% for the Ambu (P = 0.50). Overall success was 93% for the i-gel versus 98% for the Ambu (P = 0.10). Successfully inserted i-gels needed to be secured by taping in place to ensure the seal in 44% (0% with the Ambu, P < 0.01). Insertion was faster with the Ambu (24 ± 8 s vs. 27 ± 11, P = 0.02). There were no major side effects with either device. CONCLUSIONS: The leak pressure of the i-gel was statistically but not clinically significantly higher than the leak pressure of the Ambu. Time to insertion was longer with the i-gel. Both airway devices are suitable for positive pressure ventilation with high success rates in infants and children. Because the i-gel is prone to sliding out, it must be taped in place to avoid loss of the airway.