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新型双通道喉罩气道,即 LMAGastro™ 气道,在上消化道内镜检查中的有效性:一项前瞻性观察研究。

Efficacy of a new dual channel laryngeal mask airway, the LMAGastro™ Airway, for upper gastrointestinal endoscopy: a prospective observational study.

机构信息

Department of Anaesthesia and Perioperative Medicine, Royal Hobart Hospital, Hobart, Tasmania, Australia; School of Medicine, University of Tasmania, Hobart, Tasmania, Australia; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.

Department of Gastroenterology, Royal Hobart Hospital, Hobart, Tasmania, Australia.

出版信息

Br J Anaesth. 2018 Feb;120(2):353-360. doi: 10.1016/j.bja.2017.11.075. Epub 2017 Dec 1.

DOI:10.1016/j.bja.2017.11.075
PMID:29406183
Abstract

BACKGROUND

Significant cardiorespiratory events are frequent in patients undergoing gastrointestinal endoscopy. Central to the occurrence of respiratory events is an unsecured airway. This study sought to determine the efficacy of a new laryngeal mask airway, the LMAGastro Airway (Teleflex Medical, Athlone, Ireland), in patients undergoing upper gastrointestinal endoscopy. New design features include a dedicated channel for oesophageal intubation and separate channel with terminal cuff for lung ventilation.

METHODS

In a prospective, open label, observational study, 292 ASA physical status classification 1 and 2 patients at low risk of pulmonary aspiration undergoing upper gastrointestinal endoscopy received i.v. propofol anaesthesia and standardized insertion of the LMAGastro Airway. Endoscopy outcomes included insertion success, first attempt success, and ease of endoscope insertion. LMAGastro Airway outcomes included insertion success, first attempt success, ease of insertion, lowest oxygen saturation, airway compromise, laryngospasm, bloodstained device, and sore throat.

RESULTS

Per protocol analysis (n=290), the endoscopy success rate amongst the cohort with successful LMAGastro Airway insertion was 99% [95% confidence interval (CI): 98, 100]. LMAGastro Airway insertion success rate (n=292) was 99% (95% CI: 98, 100). For endoscopy and LMAGastro Airway insertion success, the lower limit of the 95% CIs was at least 98%, indicating LMAGastro Airway efficacy. Median (inter-quartile range) lowest intraoperative oxygen saturation was 98% (98, 99). Only one serious adverse event occurred (re-admission for sore throat and inability to tolerate fluids) and was reported to the Tasmanian Health and Medical Human Research Ethics Committee.

CONCLUSIONS

The LMAGastro Airway appears effective for clinical use in upper gastrointestinal endoscopy.

CLINICAL TRIAL REGISTRATION

ACTRN12616001464459.

摘要

背景

在接受胃肠内窥镜检查的患者中,严重的心肺事件较为常见。呼吸事件的发生主要与气道未得到妥善保护有关。本研究旨在确定一种新型喉罩气道——LMAGastro Airway(Teleflex Medical,爱尔兰奥唐奈)在接受上消化道内窥镜检查的患者中的疗效。新的设计特点包括用于食管插管的专用通道和用于肺通气的带有终端袖口的单独通道。

方法

在一项前瞻性、开放标签、观察性研究中,292 名美国麻醉医师协会(ASA)身体状况分类 1 级和 2 级、低误吸风险的患者接受静脉注射异丙酚麻醉,并对 LMAGastro Airway 进行标准化插入。内窥镜检查结果包括插入成功率、首次尝试成功率和内窥镜插入的难易程度。LMAGastro Airway 的结果包括插入成功率、首次尝试成功率、插入的难易程度、最低血氧饱和度、气道受损、喉痉挛、设备有血迹、咽喉痛。

结果

根据方案分析(n=290),在成功插入 LMAGastro Airway 的患者中,内窥镜成功率为 99%[95%置信区间(CI):98,100]。LMAGastro Airway 插入成功率(n=292)为 99%(95%CI:98,100)。对于内窥镜检查和 LMAGastro Airway 插入成功率,95%CI 的下限至少为 98%,表明 LMAGastro Airway 有效。术中最低血氧饱和度中位数(四分位距)为 98%(98,99)。仅发生 1 例严重不良事件(因咽喉痛和无法耐受液体而再次入院),并向塔斯马尼亚州健康和医学人类研究伦理委员会报告。

结论

LMAGastro Airway 似乎可有效用于上消化道内窥镜检查。

临床试验注册

ACTRN12616001464459。

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