Birgit Stögermüller1,2, Sigrid Ofner1, Bernhard Ziegler1, Christian Keller3, Berthold Moser3, Lukas Gasteiger4. 1. Department of Anaesthesia and Intensive Care Medicine, Paracelsus Medical University, Salzburg, Austria. 2. Department of Anaesthesia and Intensive Care, General Hospital Schwaz, Schwaz, Austria. 3. Department of Anaesthesia, Schulthess Klinik, Zurich, Switzerland. 4. Department of Anaesthesia and Intensive Care, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria. lukas.gasteiger@tirol-kliniken.at.
Abstract
PURPOSE: The Ambu® Aura Gain™ is a new second-generation supraglottic airway device that-because of a wider curvature and a wide airway tube-allows fibreoptic intubation. The purpose of this study was to assess the oropharyngeal leak pressure of the Ambu® Aura GainTM compared with the Ambu® Aura Once™. METHODS: In this randomized non-blinded crossover trial with 50 patients aged 18 months to six years (10-20 kg), we compared the Ambu®Aura Gain™ and the Ambu® Aura Once™ for airway maintenance in anesthetized, non-paralyzed participants. Our primary outcome was oropharyngeal leak pressure. Time of insertion, success rates for each device, evaluation of fibreoptic view and ventilation quality during anesthesia, as well as possible complications (e.g., blood staining) were assessed. RESULTS: There were no differences in first and overall insertion attempt rates (Ambu® Aura Once™ 50/50 (100%) vs Ambu® Aura Gain™ 50/50 (100%). Mean (standard deviation) oropharyngeal leak pressure was found to be significantly higher for Ambu® Aura Gain™ than it was for Ambu® Aura Once™ [21 (7) vs 19 (6) cmH2O, respectively; mean difference [MD] - 2 cmH2O; 95% confidence interval [CI], - 3.8 to - 1.0; P = 0.001]. Mean (SD) insertion time was faster for Ambu® Aura Once™ than for Ambu®Aura Gain™ [8 (3) vs 10 (4) seconds, respectively; MD, - 2 sec; 95% CI, - 2.9 to - 1.2; P < 0.001]. There were no differences in ventilation quality, fibreoptic view, or blood staining. CONCLUSION: We conclude that Ambu® Aura Gain™ is a good alternative to the Ambu® Aura Once™ and an efficient device for children in this age group. TRIAL REGISTRATION: www.clincaltrials.gov (NCT02811042). Registered 23 June 2016.
RCT Entities:
PURPOSE: The Ambu® Aura Gain™ is a new second-generation supraglottic airway device that-because of a wider curvature and a wide airway tube-allows fibreoptic intubation. The purpose of this study was to assess the oropharyngeal leak pressure of the Ambu® Aura GainTM compared with the Ambu® Aura Once™. METHODS: In this randomized non-blinded crossover trial with 50 patients aged 18 months to six years (10-20 kg), we compared the Ambu® Aura Gain™ and the Ambu® Aura Once™ for airway maintenance in anesthetized, non-paralyzedparticipants. Our primary outcome was oropharyngeal leak pressure. Time of insertion, success rates for each device, evaluation of fibreoptic view and ventilation quality during anesthesia, as well as possible complications (e.g., blood staining) were assessed. RESULTS: There were no differences in first and overall insertion attempt rates (Ambu® Aura Once™ 50/50 (100%) vs Ambu® Aura Gain™ 50/50 (100%). Mean (standard deviation) oropharyngeal leak pressure was found to be significantly higher for Ambu® Aura Gain™ than it was for Ambu® Aura Once™ [21 (7) vs 19 (6) cmH2O, respectively; mean difference [MD] - 2 cmH2O; 95% confidence interval [CI], - 3.8 to - 1.0; P = 0.001]. Mean (SD) insertion time was faster for Ambu® Aura Once™ than for Ambu® Aura Gain™ [8 (3) vs 10 (4) seconds, respectively; MD, - 2 sec; 95% CI, - 2.9 to - 1.2; P < 0.001]. There were no differences in ventilation quality, fibreoptic view, or blood staining. CONCLUSION: We conclude that Ambu® Aura Gain™ is a good alternative to the Ambu® Aura Once™ and an efficient device for children in this age group. TRIAL REGISTRATION: www.clincaltrials.gov (NCT02811042). Registered 23 June 2016.