Clinical performance evaluation of Ambu- Aura Gain versus I-gel in Obese female patients undergoing Short duration Surgeries under general anesthesia (CAAIOSS): a randomized controlled trial

Supraglottic airway devices (SAD) have been used to secure and maintain airways in patients during surgery or emergency situations, as well as in the management of expected and unexpected difficult airways. I-gel is a second-generation SAD which has a soft non-inflatable cuff and a gastric access port, has been widely used in patients undergoing surgery under general anesthesia. A third-generation SAD, AmbuAura Gain, has an inflatable cuff and a gastric port. One of the key features of the Ambu Aura Gain is the 90-degree angulated shaft, following the anatomy of the upper airway, which facilitates proper insertion and is associated with a high success rate for insertion. To compare the clinical performance of Ambu Aura Gain versus I-gel in patients undergoing breast surgery under general anesthesia. Patients who will undergo elective breast surgery will be randomized either to the Ambu Aura Gain group (group A) or the Igel group (Group B) (Sample size of 40 in each group). In both the groups, general anesthesia will be administered. For patients allocated to Group A, airway will be secured with Ambu Aura Gain of appropriate size (as per manufacturer’s recommendation). For patients allocated to Group B, airway will be secured with I-gel of appropriate size (as per manufacturer’s recommendation). Primary outcome to be observed will be oropharyngeal leak pressure (OLP) at 1 minute after insertion. Secondary outcome to be observed are: oropharyngeal leak pressure (OLP) at 30 minute after insertion, time and ease of insertion of SAD, no of insertion attempts, additional airway maneuvers during insertion and maintenance, fibreoptic bronchoscopic view score, ease of suction catheter placement, ventilation quality, complications. All statistical analyses will be performed using the Statistical Package for the Social Sciences software, v22.0 (SPSS Inc., Chicago, IL, USA).