Comparison of BASKA Mask and Igel Supraglottic Airway devices in Patients undergoing Elective Surgery - Randomized Control Trail

1. INTRODUCTION:

Surgical procedures under general anaesthesia require a patent airway for safe and smooth conduction of anaesthesia . For such procedures, various supraglottic airway devices have been designed and are being used exceedingly. Although endotracheal intubation is the gold standard for airway management, it is being replaced by supraglottic airway devices because they are easy to introduce, better tolerated and results in a lesser haemodynamic response. Further these devices have lesser implications on airway and respiratory mechanics.

2. RESEARCH QUESTION: IS BASKA MASK BETTER THAN I GEL IN ELECTIVE SURGERIES ?

3.AIM AND OBJECTIVES:

Aim:

Compare the effectiveness of  I-gel and Baska mask in terms of Ease of Insertion and its success rate, sealing pressure, Quality of ventilation and incidence of post insertion complications.

Primary Objective:

1)    To assess and compare the overall success rate of airway management, including successful insertion and ventilation efficacy by using the Baska mask and I-gel in patients undergoing elective surgery.

2)    To compare the ease of use and handling by healthcare providers for the Baska mask and I-gel.

Secondary Objectives:

1. To evaluate the incidence of complications (e.g., airway leaks, desaturation events) associated with the use of the Baska mask and I-gel.

2. To investigate the impact of patient characteristics (e.g., age, BMI) on the performance of the Baska mask and I-gel in elective surgery scenarios.

 5.REVIEW OF LITERATURE:

 1)   According to a study by Sinasamy et Al, Group IG showed a significantly shorter median insertion time (13.3 [interquartile range, IQR 7.8] vs. 17.0 [IQR 9.6] s; P < 0.001), a higher percentage in the ’very easy’ ease of insertion category (62.5% vs. 10.0%; P < 0.001), a higher percentage in the no corrective manoeuvre category (92.5% vs. 72.5%; P = 0.003) and a higher percentage in the no post-operative throat pain category (67.5% vs. 32.5%; P = 0.011) than Group BM. However, Group BM showed a significantly higher generated PAP than Group IG (12.7 [1.8] and 11.5 [2.2] cm H2O, respectively; P = 0.010). There were no significant differences in other parameters. (1)

 2)   A similar study by Sachidananda et Al showed that the first-time insertion success rate of the Baska® mask was 21/24 (88%) when compared with the I-gel, which was 23/25 (92%) (p=0.585). The insertion time of the Baska® mask was 14.9±6.2 s, whereas that of the I-gel was 14.7±4.4 s (p=0.877). The mean sealing pressure of the Baska® mask was significantly higher when compared with the I-gel (28.9±3.5 vs. 25.9±2.5 cmH2O) (p=0.001). (2)

  3)   According to Kara et Al, compared to I-gel, the Baska mask required a longer time for insertion, and its airway pressure was higher. The median (minimum-maximum) duration of LMA insertion in the Baska and I-gel groups was 14 (6-25) and 7 (5-12) seconds, respectively (z=-10.934; P<.001). The mean (SD) airway pressures were significantly different between the two groups (15.8 [1.9] and 14.9 [1.7] cm/H2O for Baska and I-gel, respectively; t=3.668; P<.001). Seal pressure was not significantly different between the groups (0.08 [0.2] vs. 0.07 [0.2] cm/H2O in the Baska and I-gel groups, respectively, (t=1.35; P=.194).

 4)    Based on a study by Agarwal et Al,Oropharyngeal seal pressure was significantly higher at insertion (31.70±3.67 cmH2O versus 27.3±2.93 cmH2O respectively, p value<0.001) and after deflation of carboperitoneum (31.33±3.51 cmH2O and 28.20±3.07 cmH2O respectively, p value < 0.001) in group B than group I. Time for achieving effective airway in group B was comparable to that in group I (17.83±2.05 seconds vs17.86±1.041 seconds respectively, p value=0.937). Ease of insertion of device was comparable between the two groups (p value= 0.584). Upon fibreoptic assessment, anatomical alignment of the device to larynx was comparable between the two groups (p value =0.655).