Comparisons of clinical performance of guardian laryngeal mask with laryngeal mask airway ProSeal

Abstract

BackgroundThe 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).MethodsIn 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.ResultsThe airway sealing pressure at 60cmH2O 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.ConclusionThe Guardian laryngeal mask airway was associated with high airway sealing pressure with a quicker insertion of the device as well as gastric tube.Trial registrationClinical Trial.gov Identifier: NCT02063516. Date: June 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12871-015-0039-3) contains supplementary material, which is available to authorized users.

Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine

“…The presence of blood on the device upon removal of a SGA often indicates minor trauma associated with device insertion. The reported incidence of this for the cLMA is between 12 and 15% [ 55 ] and 9 and 22% in association with the PLMA [ 56 , 57 ], depending on insertion technique. An incidence of blood staining of 20% has been described with the Guardian CPV laryngeal mask [ 57 ].…”

“…The reported incidence of this for the cLMA is between 12 and 15% [ 55 ] and 9 and 22% in association with the PLMA [ 56 , 57 ], depending on insertion technique. An incidence of blood staining of 20% has been described with the Guardian CPV laryngeal mask [ 57 ]. The typical incidence of blood on the i-gel at removal is between 4% and 13% [ 58 – 60 ] but has been reported to be as high as 20%, albeit in novice users [ 61 ].…”

A Cross-Sectional Study Evaluating the GuardianCPVTM Supraglottic Airway Device in a Clinical Setting

“…Some limitations of this study include all patients being female and paralyzed, and all insertions having been performed by one of two consultant anesthetists experienced in the use of both models. The subsequent 2015 study by Pajiyar et al showed 95% success rates of Guardian insertion with an insignificant difference to rates of Proseal insertion (n=40 each, p>0.05) with slightly superior OLP (32 vs. 29 cmH 2 O, p<0.05) [11]. Limitations of this subsequent study were similar, with all patients being female and paralyzed.…”

“…The existing literature for the Guardian LMA reports 100% success rate. [10,11] Using G * Power [12], a sample size of at least 50 was needed to identify a statistically-significant difference (one-tailed, α=0.05, β=0.80) from an expected success rate of 95% to an actual success rate of 80%.…”

Second Generation Supraglottic Airway (SGA) Devices

“…The pilot balloon valve with pressure logo indicates visual intracuff pressure (Yellow <40 cmH2O, Green 40-60 cmH2O and Red >60 cmH2O) ( Figure 10). A study suggests that it provides sealing pressures as high as 32 cm H2o [72,73].…”