Comparison of clinical performance of i-gel® and Ambu® AuraGain™ in pediatric patients: A randomized controlled study

Sarayu Venkatesan, D. Dwivedi, M. Mateen, Saurabh Sud, Bhavna Hooda, Shalendra Singh
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Abstract

Background: I-gel® is a prototype among the second-generation supraglottic airway devices (SADs). The Ambu® AuraGain™ is a fairly new, single use, second-generation SAD with a preformed shape. Aim: To compare the oropharyngeal sealing pressure (OSP) of i-gel® and AuraGain™ in young children weighing between 5 and 20 kg. Materials and Methods: This study was conducted as a single-blinded randomized control trial at a tertiary care center over the period of 18 months. Forty children, aged between 6 months and 6 years, weighing 5–20 kg, belonging to the American Society of Anesthesiologists (ASA) Physical Status I, II, and III, undergoing elective surgical procedures, were randomized into two groups: the i-gel® group and Ambu® AuraGain™ group. The primary goal was measuring OSP at 1 min postinsertion and its change at 10 min. The secondary objectives were insertion time, success rate at first attempt, the degree of ease of gastric tube insertion, and perioperative adverse effects. Results: The mean OSP was significantly higher (P < 0.05) in the i-gel group (i.e., 20.0 ± 3.24 at 1 min and 23.45 ± 3.66 at 10 min) as compared to Ambu® AuraGain™ (16.70 ± 3.10 and 19.95 ± 3.1 at 1 and 10 min, respectively). The insertion time and success and complications rate for device placement were comparable. The resistance when inserting gastric tube was significantly higher in the i-gel® group (70%) as compared to the Ambu® AuraGain™ group (20%) in our study (P < 0.05). Conclusion: Our study suggests that i-gel® is superior in achieving OSP, whereas gastric tube insertion is easy with the use of Ambu® AuraGain™.
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i-gel®和Ambu®AuraGain的临床性能比较™ 儿科患者:一项随机对照研究
背景:I-gel®是第二代声门上气道装置(SAD)的原型。Ambu®AuraGain™ 是一种全新的一次性第二代SAD,具有预制形状。目的:比较i-gel®和AuraGain的口咽密封压力(OSP)™ 材料和方法:本研究在三级护理中心进行了为期18个月的单盲随机对照试验。40名儿童,年龄在6个月至6岁之间,体重5-20公斤,属于美国麻醉师协会(ASA)身体状况I、II和III,正在接受选择性手术,被随机分为两组:I-gel®组和Ambu®AuraGain™ 组主要目标是在插入后1分钟测量OSP,并在10分钟测量其变化。次要目标是插入时间、首次尝试的成功率、插管的容易程度和围手术期不良反应。结果:与Ambu®AuraGain相比,i-gel组的平均OSP显著更高(P<0.05)(即1分钟时为20.0±3.24,10分钟时为23.45±3.66)™ (1分钟和10分钟时分别为16.70±3.10和19.95±3.1)。植入时间、装置放置的成功率和并发症发生率具有可比性。与Ambu®AuraGain相比,i-gel®组插入胃导管时的阻力显著更高(70%)™ 结论:我们的研究表明i-gel®在实现OSP方面更为优越,而使用Ambu®AuraGain则更容易插入胃导管™.
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