Abstract
BACKGROUND: The Guardian Laryngeal Mask Airway (G-LMA) is a new silicone-based single-use extraglottic device with the drainage port and a cuff pilot valve with pressure indicator. The aim of this study is to compare the clinical performance of this laryngeal mask airway with ProSeal laryngeal mask airway (P-LMA). METHODS: In this prospective randomized study, we included adult patients with ASA grading I and II scheduled for elective surgery requiring supine position under total intravenous anesthesia. The patients were randomly allocated to two groups, 40 in each. G-LMA and P-LMA were used in groups G and P respectively. The cuff of each device was air inflated to 60 cmH2O. The primary outcome was to compare the airway sealing pressure and the secondary outcome was to compare the efficacy and safety of these two devices with respect to insertion success, insertion time, ease of insertion, volume of air for cuff inflation to 60 cmH2O, intracuff pressure measurement, gastric tube insertion attempt, gastric tube insertion time, Fiberoptic laryngeal view, and postoperative pharyngolaryngeal morbidity. RESULTS: The airway sealing pressure at 60 cmH2O cuff pressure was significantly greater in G-LMA than P-LMA (p = 0.04).The first successful attempt of both groups were comparable (p = 1.000). Insertion time was significantly shorter in G-LMA than P-LMA (p < 0.0001). The first successful attempt for the gastric tube insertion in both groups was comparable (p = 0.431). Gastric tube insertion time was less in G-LMA than in P-LMA (p < 0.0001). The volume of air for cuff inflation to 60 cmH2O was more in G-LMA than in P-LMA (<0.0001). The intracuff pressure measurement at 30, 60, 90 and 120 minutes were comparable (p = 0.823, 0.182, 0.870, 0.658).We did not find differences in ease of insertion (p = 0.60); Fiber-optic positions of airway devices were comparable (p = 0.83). In addition, blood staining (p = 1.00), sore throat and dysphagia at 1, 2 and 24 hour (p = 1.00) were comparable in both groups. CONCLUSION: The Guardian laryngeal mask airway was associated with high airway sealing pressure with a quicker insertion of the device as well as gastric tube. TRIAL REGISTRATION: Clinical Trial.gov Identifier: NCT02063516. Date: June 2013.