卫氏喉罩与ProSeal喉罩气道的临床性能比较。
Comparisons of clinical performance of Guardian laryngeal mask with laryngeal mask airway ProSeal.
作者信息
Pajiyar Ajay Kumar, Wen Zhiting, Wang Haiyun, Ma Lin, Miao Lumin, Wang Guolin
机构信息
Department of Anesthesiology, Tianjin Medical University General Hospital, Tianjin Research Institute of Anesthesiology, No 154 Anshan Road, Heping District, Tianjin, 300052, China.
Department of Anesthesiology, Tianjin Children's Hospital, Tianjin, 300074, China.
出版信息
BMC Anesthesiol. 2015 May 1;15:69. doi: 10.1186/s12871-015-0039-3.
BACKGROUND
The 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).
METHODS
In 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.
RESULTS
The airway sealing pressure at 60 cmH2O 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.
CONCLUSION
The Guardian laryngeal mask airway was associated with high airway sealing pressure with a quicker insertion of the device as well as gastric tube.
TRIAL REGISTRATION
Clinical Trial.gov Identifier: NCT02063516. Date: June 2013.
背景
卫氏喉罩气道（G-LMA）是一种新型的一次性使用的基于硅胶的声门上气道装置，带有引流口和带压力指示器的套囊先导阀。本研究的目的是比较这种喉罩气道与食管引流型喉罩气道（P-LMA）的临床性能。
方法
在这项前瞻性随机研究中，我们纳入了计划在全静脉麻醉下仰卧位进行择期手术的美国麻醉医师协会（ASA）分级为I级和II级的成年患者。患者被随机分为两组，每组40例。G组和P组分别使用G-LMA和P-LMA。每个装置的套囊充气至60 cmH₂O。主要结局是比较气道密封压力，次要结局是比较这两种装置在插入成功率、插入时间、插入 ease、套囊充气至60 cmH₂O的空气量、套囊内压力测量、胃管插入尝试、胃管插入时间、纤维喉镜视野以及术后咽喉部发病率方面的有效性和安全性。
结果
在套囊压力为60 cmH₂O时，G-LMA的气道密封压力显著高于P-LMA（p = 0.04）。两组的首次成功尝试相当（p = 1.000）。G-LMA的插入时间显著短于P-LMA（p < 0.0001）。两组胃管插入的首次成功尝试相当（p = 0.431）。G-LMA的胃管插入时间少于P-LMA（p < 0.0001）。G-LMA套囊充气至60 cmH₂O的空气量多于P-LMA（<0.0001）。在30、60、90和120分钟时的套囊内压力测量相当（p = 0.823、0.182、0.870、0.658）。我们未发现插入 ease 方面的差异（p = 0.60）；气道装置的纤维光学位置相当（p = 0.83）。此外，两组的血染情况（p = 1.00）以及1、2和24小时时的咽痛和吞咽困难（p = 1.00）相当。
结论
卫氏喉罩气道具有较高的气道密封压力，且装置及胃管的插入更快。
试验注册
ClinicalTrials.gov标识符：NCT02063516。日期：2013年6月。
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