临床实践中的儿科声门上气道装置：一项前瞻性观察性研究。
Pediatric supraglottic airway devices in clinical practice: A prospective observational study.
作者信息
Kleine-Brueggeney Maren, Gottfried Anne, Nabecker Sabine, Greif Robert, Book Malte, Theiler Lorenz
机构信息
Department of Anaesthesiology and Pain Therapy, Inselspital, University Hospital Bern, University of Bern, Freiburgstrasse, 3010, Bern, Switzerland.
Present address: Department of Anaesthesia, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
出版信息
BMC Anesthesiol. 2017 Sep 2;17(1):119. doi: 10.1186/s12871-017-0403-6.
BACKGROUND
Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™.
METHODS
This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmHO ± 10%.
RESULTS
None of the SGA showed a mean airway leak pressure of 20 cmHO ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmHO, Air-Q® 15.9 (3.2) cmHO, Ambu® Aura-i™ 17.3 (3.7) cmHO, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™, <p = 0.005). Insertion was rated easiest with the LMA Supreme™ (very easy in 97% vs. Air-Q® 70%, Ambu® Aura-i™ 72%, p < 0.001). Fiberoptic view was similar between the SGA. Adverse events were rare.
CONCLUSIONS
Airway leak pressures ranged from 16 to 18 cmHO, enabling positive pressure ventilation with all successful SGA. The highest success rates were achieved by the LMA Supreme™, which was also rated easiest to insert.
TRIALS REGISTRATION
ClinicalTrials.gov , identifier NCT01625858 . Registered 31 May 2012.
背景
声门上气道装置（SGA）常用于小儿麻醉，是困难气道管理的主要或备用装置。大多数SGA在未经过适当临床评估的情况下上市。本研究的目的是评估小儿LMA Supreme™、Air-Q®和Ambu® Aura-i™的性能。
方法
这项前瞻性观察性研究在瑞士伯尔尼大学医院进行。经伦理委员会批准并豁免书面知情同意书，纳入了240例接受择期手术、美国麻醉医师协会（ASA）分级为I-III级且体重为5-30 kg的儿童。评估了三种不同的小儿声门上气道装置：LMA Supreme™、Air-Q®和Ambu® Aura-i™。主要结局参数是气道泄漏压力。次要结局参数包括首次尝试成功率和总体成功率、插入时间、通过SGA的纤维喉镜视野以及不良事件。主要假设是每个测试的SGA的平均气道泄漏压力为20 cmH₂O±10%。
结果
没有一种SGA的平均气道泄漏压力为20 cmH₂O±10%，但不同装置之间的平均气道泄漏压力有显著差异[LMA Supreme™为18.0（3.4）cmH₂O，Air-Q®为15.9（3.2）cmH₂O，Ambu® Aura-i™为17.3（3.7）cmH₂O，p<0.001]。首次尝试成功率（LMA Supreme™为100%，Air-Q®为90%，Ambu® Aura-i™为91%，p = 0.02）和总体成功率（LMA Supreme™为100%，Air-Q®为91%，Ambu® Aura-i™为95%，p = 0.02）也有显著差异。插入时间从20（7）秒（Air-Q®）到24（6）秒（LMA Supreme™，p<0.005）不等。LMA Supreme™的插入被评为最容易（97%为非常容易，而Air-Q®为70%，Ambu® Aura-i™为72%，p<0.001）。SGA之间的纤维喉镜视野相似。不良事件很少见。
结论
气道泄漏压力范围为16至18 cmH₂O，所有成功的SGA均可进行正压通气。LMA Supreme™的成功率最高，其插入也被评为最容易。
试验注册
ClinicalTrials.gov，标识符NCT01625858。2012年5月31日注册。
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