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亚洲儿童中1.5号Supreme™喉罩与Proseal™喉罩临床性能比较:一项随机对照试验。

Comparison of clinical performance of size 1.5 Supreme™ LMA and Proseal™ LMA among Asian children: a randomized controlled trial.

作者信息

Chaw Sook Hui, Shariffuddin Ina I, Foo Li Lian, Lee Pui Kuan, Paran Ramona Maya, Cheang Peak Chee, Chan Lucy

机构信息

Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.

Department of Anaesthesiology, University Malaya Medical Centre, Kuala Lumpur, Malaysia.

出版信息

J Clin Monit Comput. 2018 Dec;32(6):1093-1099. doi: 10.1007/s10877-018-0109-4. Epub 2018 Feb 5.

Abstract

To date, most of the studies on safety and efficacy of supraglottic airway devices were done in Caucasian patients, and the results may not be extrapolated to Asian patients due to the different airway anatomy. We conducted this study to compare Supreme™ LMA (SLMA) and Proseal™ LMA (PLMA) size 1.5 in anaesthetized children among an Asian population. This prospective randomized clinical trial was conducted in a tertiary teaching hospital from September 2013 until May 2016. Sixty children, weighing 5-10 kg, who were scheduled for elective surgery under general anaesthesia were recruited and completed the study. Patients were randomly assigned to have either SLMA or PLMA as the airway device for general anaesthesia, and standard anaesthesia protocol was followed. The primary outcome measured was the oropharyngeal leak pressure (OLP). The rate of successful insertion, insertion time, fibreoptic view of larynx and airway complications for each device were also assessed. There were no statistically significant differences between SLMA and PLMA size 1.5 in oropharyngeal leak pressure [19.1 (± 5.5) cmHO vs. 19.8 (± 4.5) cmHO, p = 0.68]. Secondary outcomes including time to insertion [20.8 (± 8.3) vs. 22.1 (± 8.3) s, p = 0.57], first attempt success rate for device insertion, fibreoptic view of larynx, and airway complications were also comparable between the two devices. We found that all the patients who had a failed device insertion (either PLMA or SLMA) were of a smaller size (5-6.2 kg). The oropharyngeal leak pressure of the SLMA 1.5 was comparable with the PLMA 1.5, and both devices were able to maintain an airway effectively without significant clinical complications in anaesthetized children from an Asian population.

摘要

迄今为止,大多数关于声门上气道装置安全性和有效性的研究是在白种人患者中进行的,由于气道解剖结构不同,研究结果可能无法外推至亚洲患者。我们开展这项研究以比较亚洲人群中麻醉儿童使用的1.5号Supreme™喉罩气道(SLMA)和1.5号Proseal™喉罩气道(PLMA)。这项前瞻性随机临床试验于2013年9月至2016年5月在一家三级教学医院进行。招募了60名体重5 - 10千克、计划在全身麻醉下进行择期手术的儿童并完成了研究。患者被随机分配使用SLMA或PLMA作为全身麻醉的气道装置,并遵循标准麻醉方案。测量的主要结局指标是口咽漏气压(OLP)。还评估了每种装置的成功插入率、插入时间、喉镜光纤视野和气道并发症。1.5号SLMA和1.5号PLMA在口咽漏气压方面无统计学显著差异[19.1(±5.5)cmH₂O对19.8(±4.5)cmH₂O,p = 0.68]。包括插入时间[20.8(±8.3)对22.1(±)8.3秒,p = 0.57]、装置插入首次尝试成功率、喉镜光纤视野和气道并发症等次要结局在两种装置之间也具有可比性。我们发现所有装置插入失败的患者(无论是PLMA还是SLMA)体型都较小(5 - 6.2千克)。1.5号SLMA的口咽漏气压与1.5号PLMA相当,两种装置都能够有效地维持气道,且在亚洲人群的麻醉儿童中无明显临床并发症。

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