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预期直接喉镜检查困难患者首次尝试视频喉镜插管成功率:一项多中心随机对照试验,比较C-MAC D型镜片与GlideScope在混合医疗人员和多样化患者群体中的应用

First-Attempt Intubation Success of Video Laryngoscopy in Patients with Anticipated Difficult Direct Laryngoscopy: A Multicenter Randomized Controlled Trial Comparing the C-MAC D-Blade Versus the GlideScope in a Mixed Provider and Diverse Patient Population.

作者信息

Aziz Michael F, Abrons Ron O, Cattano Davide, Bayman Emine O, Swanson David E, Hagberg Carin A, Todd Michael M, Brambrink Ansgar M

机构信息

From the Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, Portland, Oregon; Department of Anesthesia, University of Iowa, Iowa City, Iowa; and Department of Anesthesiology, University of Texas at Houston, Houston, Texas.

出版信息

Anesth Analg. 2016 Mar;122(3):740-750. doi: 10.1213/ANE.0000000000001084.

Abstract

BACKGROUND

Intubation success in patients with predicted difficult airways is improved by video laryngoscopy. In particular, acute-angle video laryngoscopes are now frequently chosen for endotracheal intubation in these patients. However, there is no evidence concerning whether different acute-angle video laryngoscopes can be used interchangeably in this scenario and would allow endotracheal intubation with the same success rate. We therefore tested whether first-attempt intubation success is similar when using a newly introduced acute-angle blade, that is an element of an extended airway management system (C-MAC D-Blade) compared with a well-established acute-angle video laryngoscope (GlideScope).

METHODS

In this large multicentered prospective randomized controlled noninferiority trial, patients requiring general anesthesia for elective surgery and presenting with clinical predictors of difficult laryngoscopy were randomly assigned to intubation using either the C-MAC D-Blade or the GlideScope video laryngoscope. The hypothesis was that first-attempt intubation success using the new device (D-Blade) is no >4% less than the established device (GlideScope), which would determine noninferiority of the new instrument versus the established instrument. The secondary outcomes we observed included intubation success with multiple attempts and airway-related complications within 7 days of enrollment.

RESULTS

Eleven hundred patients were randomly assigned to either video laryngoscope. Intubation success rate on first attempt was 96.2% in the GlideScope group and 93.4% in the C-MAC D-Blade group. Although the absolute difference between the 2 groups was only 2.8%, the 90.35% upper confidence limit of the difference exceeded the predefined margin (4.98%), indicating a rejection of the noninferiority hypothesis for first-attempt intubation success. For attending anesthesiologists, and upon multiple attempts, intubation success did not differ between systems. Pharyngeal injury was noted in 1% of the patients, and the incidence did not differ between interventional groups.

CONCLUSIONS

Head-to-head comparison in this large multicenter trial revealed that the newly introduced C-MAC D-Blade does not yield the same first-attempt intubation success as the GlideScope in patients with predicted difficult laryngoscopy except in the hands of attending anesthesiologists. Additional research would be necessary to identify potential causes for this difference. Intubation success rates were very high with both systems, indicating that acute-angle video laryngoscopy is an exceptionally successful strategy for the initial approach to endotracheal intubation in patients with predicted difficult laryngoscopy.

摘要

背景

视频喉镜可提高预计气道困难患者的插管成功率。特别是,现在锐角视频喉镜常用于这些患者的气管插管。然而,尚无证据表明在这种情况下不同的锐角视频喉镜是否可以互换使用,并能达到相同的气管插管成功率。因此,我们测试了与成熟的锐角视频喉镜(GlideScope)相比,使用新推出的锐角喉镜(即扩展气道管理系统的一个组件,C-MAC D型喉镜)进行首次插管时成功率是否相似。

方法

在这项大型多中心前瞻性随机对照非劣效性试验中,因择期手术需要全身麻醉且具有喉镜检查困难临床预测因素的患者,被随机分配使用C-MAC D型喉镜或GlideScope视频喉镜进行插管。假设是使用新设备(D型喉镜)进行首次插管的成功率比成熟设备(GlideScope)低不超过4%,这将确定新器械相对于成熟器械的非劣效性。我们观察的次要结局包括多次尝试插管的成功率以及入组后7天内与气道相关的并发症。

结果

1100例患者被随机分配至两种视频喉镜组。GlideScope组首次插管成功率为96.2%,C-MAC D型喉镜组为93.4%。虽然两组之间的绝对差异仅为2.8%,但差异的90.35%置信上限超过了预先设定的界限(4.98%),表明首次插管成功率的非劣效性假设被拒绝。对于主治麻醉医生而言,在多次尝试后,不同系统的插管成功率没有差异。1%的患者出现咽部损伤,各干预组的发生率无差异。

结论

在这项大型多中心试验中的直接比较显示,除了主治麻醉医生使用外,新推出的C-MAC D型喉镜在预计喉镜检查困难的患者中首次插管成功率与GlideScope不同。需要进一步研究以确定造成这种差异的潜在原因。两种系统的插管成功率都非常高,表明锐角视频喉镜是预计喉镜检查困难患者初次气管插管的一种非常成功的策略。

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