Lukas Gasteiger1, Helmuth Tauber2, Corinna Velik-Salchner1, Matthias Thoma1, Raffaella Fantin1, Vitaliy Pustilnik1, Sabrina Neururer3, Christian Keller4, Berthold Moser5. 1. Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße 35, A-6020, Innsbruck, Austria. 2. Department of Anesthesia and Intensive Care Medicine, Medical University Innsbruck, Anichstraße 35, A-6020, Innsbruck, Austria. Helmuth.tauber@tirol-kliniken.at. 3. Department of Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria. 4. Department of Anaesthesiology, Schulthess Klinik, Schulthess, Switzerland. 5. Department of Anaesthesiology, Spital Limmattal, Zurich, Switzerland.
Abstract
BACKGROUND: Supraglottic airway devices perform more poorly and have lower oropharyngeal leak pressure in edentulous patients than in patients with teeth. The Ambu Aura Gain is a newer second generation supraglottic airway device. OBJECTIVE: This randomized clinical trial assessed the oropharyngeal leak pressure in edentulous patients using the Ambu Aura Gain with a gastric tube for insertion guidance and without insertion guidance. MATERIAL AND METHODS: Patients with ASA (American Society of Anesthesiology) physical status I-III were recruited. Primary outcome was oropharyngeal leak pressure after insertion. Secondary outcome parameters were oropharyngeal leak pressure 15 min and 30 min after insertion, insertion time, insertion attempts and glottis view through flexible fiberscope. RESULTS: In this study 72 patients aged between 51 and 90 years (mean 73 years) were randomly allocated to the "with guidance" (n = 36) or the "without guidance" group (n = 36). Mean (SD) oropharyngeal leak pressure in "with guidance" and "without guidance" group was 24 cm H2O and 24 cm H2O (ns), respectively. A difference was found in mean insertion timewith guidance versus without guidance group 52 s (45 s) vs. 26 s (15 s) (p < 0.001). No difference was found in any of the other secondary outcome parameters. CONCLUSION: A guided insertion technique does not improve oropharyngeal leak pressure of the Ambu AuraGain™ in edentulous patients. As the only difference is an increase in insertion time this technique is of no benefit for this population.
RCT Entities:
BACKGROUND: Supraglottic airway devices perform more poorly and have lower oropharyngeal leak pressure in edentulous patients than in patients with teeth. The Ambu Aura Gain is a newer second generation supraglottic airway device. OBJECTIVE: This randomized clinical trial assessed the oropharyngeal leak pressure in edentulous patients using the Ambu Aura Gain with a gastric tube for insertion guidance and without insertion guidance. MATERIAL AND METHODS:Patients with ASA (American Society of Anesthesiology) physical status I-III were recruited. Primary outcome was oropharyngeal leak pressure after insertion. Secondary outcome parameters were oropharyngeal leak pressure 15 min and 30 min after insertion, insertion time, insertion attempts and glottis view through flexible fiberscope. RESULTS: In this study 72 patients aged between 51 and 90 years (mean 73 years) were randomly allocated to the "with guidance" (n = 36) or the "without guidance" group (n = 36). Mean (SD) oropharyngeal leak pressure in "with guidance" and "without guidance" group was 24 cm H2O and 24 cm H2O (ns), respectively. A difference was found in mean insertion time with guidance versus without guidance group 52 s (45 s) vs. 26 s (15 s) (p < 0.001). No difference was found in any of the other secondary outcome parameters. CONCLUSION: A guided insertion technique does not improve oropharyngeal leak pressure of the Ambu AuraGain™ in edentulous patients. As the only difference is an increase in insertion time this technique is of no benefit for this population.