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内置压力指示器的新型声门上气道可减少术后咽喉症状:一项随机对照试验。

New supraglottic airway with built-in pressure indicator decreases postoperative pharyngolaryngeal symptoms: a randomized controlled trial.

机构信息

Department of Anesthesia, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada,

出版信息

Can J Anaesth. 2013 Dec;60(12):1197-203. doi: 10.1007/s12630-013-0044-2. Epub 2013 Oct 5.

DOI:10.1007/s12630-013-0044-2
PMID:24097301
Abstract

PURPOSE

Excessive supraglottic airway cuff pressure increases postoperative pharyngolaryngeal symptoms such as sore throat, dysphonia, and dysphagia. A new supraglottic airway, AES Ultra CPV™ (CPV), has a built-in intracuff pressure indicator. We hypothesized that using the CPV would reduce postoperative symptoms when compared with the LMA Classic™ (LMA) without intracuff pressure guidance.

METHODS

Ambulatory patients undergoing general anesthesia were randomized to either CPV or LMA. A size 3/4/5 was inserted according to manufacturer guidelines. Nitrous oxide was not used. In the LMA Group, the cuff was inflated according to manufacturer's guidelines. In the CPV Group, a CPV was inserted and the cuff inflated until the indicator was in the green zone (30-44 mmHg). Intracuff pressures were measured at five minutes and 20 min post-insertion in both groups. The primary outcome was the incidence of pharyngolaryngeal symptoms, defined as sore throat, dysphonia, and/or dysphagia at one, two, and/or 24 hr postoperatively. Continuous data were compared using Student's t test and categorical data were analyzed using Chi square analysis.

RESULTS

The study included 170 patients, 85 per group. The mean (SD) intracuff pressure in the CPV group was significantly lower [44 (4) mmHg] than in the LMA Group [87 (37) mmHg]; P < 0.001. The incidence of pharyngolaryngeal symptoms was significantly lower in the CPV Group than in the LMA Group (26% vs 49%; P = 0.002). The absolute risk reduction was 24%, and the number-needed-to-treat was 4.3.

CONCLUSION

The incidence of postoperative pharyngolaryngeal symptoms in the CPV Group with a cuff pressure-guided strategy was significantly lower than in the LMA Group with standard practice. (

CLINICAL TRIAL REGISTRATION NUMBER

NCT01800344).

摘要

目的

过度的声门上气道套囊压力会增加术后咽喉部症状,如咽痛、声音嘶哑和吞咽困难。一种新型的声门上气道装置 AES Ultra CPV™(CPV)内置有套囊内压力指示器。我们假设与没有套囊内压力指导的 LMA Classic™(LMA)相比,使用 CPV 会降低术后症状。

方法

择期全身麻醉的患者被随机分为 CPV 组或 LMA 组。根据制造商的指南插入 3/4/5 号器械。不使用一氧化二氮。在 LMA 组,根据制造商的指南充气套囊。在 CPV 组,插入 CPV 并充气直至指示器处于绿色区域(30-44mmHg)。在两组中,在插入后 5 分钟和 20 分钟测量套囊内压力。主要结局是咽喉部症状的发生率,定义为术后 1、2 和/或 24 小时时出现咽痛、声音嘶哑和/或吞咽困难。连续数据采用 Student's t 检验进行比较,分类数据采用卡方分析进行分析。

结果

该研究纳入了 170 例患者,每组 85 例。CPV 组的平均(SD)套囊内压力明显低于 LMA 组[44(4)mmHg] [87(37)mmHg];P < 0.001。CPV 组的咽喉部症状发生率明显低于 LMA 组(26%比 49%;P = 0.002)。绝对风险降低 24%,需要治疗的人数为 4.3。

结论

CPV 组采用套囊压力指导策略的术后咽喉部症状发生率明显低于 LMA 组采用标准操作。(临床试验注册号:NCT01800344)。

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