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新型视频辅助插管喉罩Totaltrack与插管喉罩Fastrach的比较——一项对照随机人体模型研究

The novel video-assisted intubating laryngeal mask Totaltrack compared to the intubating laryngeal mask Fastrach - a controlled randomized manikin study.

作者信息

Ott T, Barth A, Kriege M, Jahn-Eimermacher A, Piepho T, Noppens R R

机构信息

Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.

Institute of Medical Biostatistics, Epidemiology and Informatics, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.

出版信息

Acta Anaesthesiol Scand. 2017 Apr;61(4):381-389. doi: 10.1111/aas.12872.

Abstract

BACKGROUND

The novel Totaltrack combines a supraglottic airway device with video laryngoscopic tracheal intubation. The intubation laryngeal mask Fastrach is an established device without visual control of intubation. We hypothesized that supraglottic ventilation success with Totaltrack would be similar to Fastrach, but intubation would be performed faster due to visual control of the procedure.

METHODS

Fifty-five anaesthesiologists were randomized into one of two study arms: Fastrach Totaltrack. After a standardized introduction, six consecutive attempts of supraglottic ventilation and intubation attempts with each of one of the devices were performed on an airway manikin. The combined primary outcome was: time to supraglottic ventilation and time to ventilation after intubation. Additionally, success rate and learning curves were evaluated.

RESULTS

Supraglottic time to ventilation was shorter when using the Fastrach compared to the Totaltrack (median: 7.8 s [confidence interval [CI]: 7.0-8.6 s] vs. 11 s [CI: 7.8-14.2 s], P < 0.001). Intubation was faster using the Fastrach compared to Totaltrack (median: 12.5 s, [CI: 10.1-14.9 s] vs. 23.3 s [CI: 21.5-25.1 s], P < 0.001). Success rate for supraglottic ventilation was comparable between Fastrach and Totaltrack (86-96%). Successful intubation via the device was 100% in Fastrach and ranged from 61% to 93% in Totaltrack, with a higher probability of successful intubation after four applications.

CONCLUSION

In this manikin-based study the novel Totaltrack did not prove superior to Fastrach despite a similar design. Video laryngoscopic control of supraglottic ventilation and endotracheal intubation was prolonged using the Totaltrack. Clinical trials are mandatory to evaluate the role of the Totaltrack in airway management.

摘要

背景

新型Totaltrack将声门上气道装置与视频喉镜气管插管相结合。插管喉罩Fastrach是一种成熟的装置,但插管过程无视觉控制。我们假设使用Totaltrack进行声门上通气的成功率与Fastrach相似,但由于该操作有视觉控制,插管速度会更快。

方法

55名麻醉医生被随机分为两个研究组之一:Fastrach组和Totaltrack组。在进行标准化介绍后,使用其中一种装置在气道模型上连续进行6次声门上通气尝试和插管尝试。综合主要结局指标为:声门上通气时间和插管后通气时间。此外,还评估了成功率和学习曲线。

结果

与Totaltrack相比,使用Fastrach时声门上通气时间更短(中位数:7.8秒[置信区间[CI]:7.0 - 8.6秒] vs. 11秒[CI:7.8 - 14.2秒],P < 0.001)。与Totaltrack相比,使用Fastrach时插管速度更快(中位数:12.5秒,[CI:10.1 - 14.9秒] vs. 23.3秒[CI:21.5 - 25.1秒],P < 0.001)。Fastrach和声门上通气成功率在Fastrach和Totaltrack之间相当(86% - 96%)。通过Fastrach装置成功插管率为100%,而Totaltrack的成功率在61%至93%之间,在应用4次后成功插管的概率更高。

结论

在这项基于模型的研究中,尽管设计相似,但新型Totaltrack并未证明优于Fastrach。使用Totaltrack进行声门上通气和气管插管的视频喉镜控制时间延长。必须进行临床试验以评估Totaltrack在气道管理中的作用。

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