A Study to evaluate the efficacy and safety of I-GEL and Baska Mask in Adult patients posted for non-emergency surgeries under GA

Abstract

Background: Extraglottic airway devices (EADs) which are also known as supralaryngeal airways (SLA) or supraglottic airway devices (SADs, SGAs) are an integral part of modern anesthetic practice. After induction of anesthesia, SAD’s are inserted into oral cavity which helps to maintain airway patency. The Baska mask which is the third generation SAD is introduced recently in the SAD market. When compared to second generation SAD, Baska mask has several novel features. Objectives: To evaluate the efficacy and safety of I-GEL and Baska Mask in Adult patients posted for non-emergency surgeries under GA (General anesthesia) regarding oropharyngeal Leak Pressure. Materials and Methods: The present prospective Randomized Single Blind Comparative study was undertaken from November 2018 to April 2020 from the Department of Anesthesia in JSS Medical College and Hospital Mysore Taking a difference of 10 cmH2O sealing pressure between Baska mask and I Gel as significant based on our pilot studies and previous studies considering alpha and beta values, we got our sample size as 63 in Baska group and 63 in I-gel group. We studied a total of 300 patients and into two groups of 150 in order to increase the power of the study. Results: OLP of Baska mask which is our primary objective was 40.45cmH2O which provided better sealing pressure than I-gel (30.29cmH20), with statistical significance (p value less than 0.0001). There was a statistical significance (p < 0.001) in the Brimacombe scoring of Glottic view. The increase in pulse rate soon after insertion was more with Baska than with I-gel (p=0.005), though it was not significant clinically. Similarly, though there was a rise in SBP (systolic blood pressure) after inserting the device in group Baska more than in the group I-Gel, it was not clinically significant(p=0.0001). Conclusion: The OLP for Baska mask which was our primary objective is superior to that of I-Gel. The ease of insertion was better with I-gel requiring lesser time for insertion but a significantly better fiber-optic view was provided by Baska mask. However, Baska mask may have clinical advantage by providing a favorable Brimacombe scoring, better OLP and hence an improved safety profile.