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经典型、Fastrach型和Supreme型喉罩气道三种声门上气道装置的比较:一项关于疗效、安全性和并发症的前瞻性随机临床试验

Comparison of the Supraglottic Airway Devices Classic, Fastrach and Supreme Laryngeal Mask Airway: A Prospective Randomised Clinical Trial of Efficacy, Safety and Complications.

作者信息

Kömür Erdal, Bakan Nurten, Tomruk Şenay Göksu, Karaören Gülşah, Doğan Zelin Topaç

机构信息

Clinic of Anaesthesiology and Reanimation, Ümraniye Training and Research Hospital, İstanbul, Turkey.

出版信息

Turk J Anaesthesiol Reanim. 2015 Dec;43(6):406-11. doi: 10.5152/TJAR.2015.97830. Epub 2015 Dec 1.

Abstract

OBJECTIVE

This prospective randomised study was designed to compare the Laryngeal Mask Airway (LMA) Classic, LMA Fastrach and LMA Supreme regarding ease of insertion and insertion time as primary outcomes and reposition, success rate of trials, effects on haemodynamic parameters, provision of an adequate and safe airway, amount of leakage and oropharyngeal and systemic complications as secondary outcomes.

METHODS

In this clinical trial, 90 patients aged 18-70 years of American Society of Anesthesiologists (ASA) group I-II were randomised into three groups as providing airway via LMA Classic, LMA Fastrach or LMA Supreme instead of tracheal intubation. No muscle relaxant was used. The allocated LMA was inserted by the same anaesthetist; bispectral index (BIS) was between 40% and 60%.

RESULTS

There was no statistical difference among the groups regarding the ease of insertion and insertion time as primary outcomes; the incidence of repositioning during placement was significantly higher in the LMA Classic group than that in other groups (p<0.05) and the rates of bloodstain on the device as well as oropharyngeal mucosal oedema were higher in the LMA Fastrach group than those in other groups (p<0.05) as secondary outcomes.

CONCLUSION

We suggest that LMA Classic, LMA Supreme and LMA Fastrach had similar effectiveness regarding efficiency and airway safety. However, LMA Supreme seems to be more advantageous as it is more appropriate for fewer oropharyngeal complications and there was no repositioning.

摘要

目的

本前瞻性随机研究旨在比较经典喉罩气道(LMA Classic)、Fastrach喉罩气道(LMA Fastrach)和至尊喉罩气道(LMA Supreme),将插入的难易程度和插入时间作为主要观察指标,将重新定位、置入尝试成功率、对血流动力学参数的影响、提供充足且安全的气道、漏气量以及口咽和全身并发症作为次要观察指标。

方法

在这项临床试验中,90例年龄在18至70岁的美国麻醉医师协会(ASA)I-II级患者被随机分为三组,分别通过LMA Classic、LMA Fastrach或LMA Supreme提供气道,而非气管插管。未使用肌肉松弛剂。由同一位麻醉医师插入分配的喉罩;脑电双频指数(BIS)维持在40%至60%之间。

结果

作为主要观察指标,各组在插入的难易程度和插入时间方面无统计学差异;作为次要观察指标,LMA Classic组在放置过程中的重新定位发生率显著高于其他组(p<0.05),LMA Fastrach组设备上的血迹发生率以及口咽黏膜水肿发生率高于其他组(p<0.05)。

结论

我们认为,LMA Classic, LMA Supreme和LMA Fastrach在效率和气道安全性方面具有相似的有效性。然而,LMA Supreme似乎更具优势,因为它引发的口咽并发症较少且无需重新定位。

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