Clinical Efficacy of Ambu Aura Gain vs Laryngeal Mask Airway Proseal in Paediatric Patients Undergoing Elective Surgery under General Anaesthesia: A Randomised Controlled Trial

Abstract

Introduction: Laryngeal Mask Airway ProSeal (LMA-P) is considered a gold standard among second generation supra glottis airway devices as an effective, safe and reusable ventilatory device. Ambu Aura Gain (AAG) is a newer single use second generation airway device with a soft inflatable cuff and preformed shape. Aim: To compare the clinical effectiveness and oral pharyngeal seal pressures between LMA ProSeal and AAG in children receiving controlled ventilation. Materials and Methods: This study was conducted in 100 paediatric patients in age group of 1 to 12 years, weighing 5 to 30 kg, fulfilling the criteria of American Society of Anaesthesiologists (ASA) Physical Status I and II and undergoing elective surgical procedures. Patients were randomised into two groups. Secondary objective was to compare the ease, success and total time for achieving effective ventilation and ease of placement of gastric tube and fibreoptic visualisation of glottis view in both the groups. Quantitative variables were compared using Independent t-test/Mann-Whitney Test and qualitative variables were compared using Chi-Square test/Fisher’s-Exact test. Results: The median (IQR) Oropharyngeal Seal Pressure (OSP) was much higher with AAG 22 cm (21-23) of water as compared to LMA ProSeal 21 cm (20-22) of water and the difference was statistically significant (p-value <0.0001). Time taken for achieving effective ventilation {median (IQR)} was significantly less with AAG {18 (17-19) seconds} as compared to that with LMA ProSeal {19 (18-20) seconds} (p=0.0005). The two devices were comparable in terms of success and ease of insertion of device, ease of placement of gastric tube and fibreoptic visualisation of glottis view. Conclusion: The study suggests that AAG, a single use device, is a useful substitute to LMA ProSeal to ventilate paediatric patients undergoing elective surgical procedures.