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一项关于单次使用 i-view 与标准可重复使用视频喉镜在急诊插管成功率方面的前瞻性、务实的非劣效性研究。

A prospective, pragmatic non-inferiority study of emergency intubation success with the single-use i-view versus standard reusable video laryngoscope.

机构信息

US Army Institute of Surgical Research, JBSA Fort Sam Houston, Texas, USA.

Brooke Army Medical Center, JBSA, JBSA Fort Sam Houston, Texas, USA.

出版信息

Transfusion. 2024 May;64 Suppl 2:S201-S209. doi: 10.1111/trf.17790. Epub 2024 Mar 28.

Abstract

INTRODUCTION

Video laryngoscope (VL) technology improves first-pass success. The novel i-view VL device is inexpensive and disposable. We sought to determine the first-pass intubation success with the i-view VL device versus the standard reusable VL systems in routine use at each site.

METHODS

We performed a prospective, pragmatic study at two major emergency departments (EDs) when VL was used. We rotated i-view versus reusable VL as the preferred device of the month based on an a priori schedule. An investigator-initiated interim analysis was performed. Our primary outcome was a first-pass success with a non-inferiority margin of 10% based on the per-protocol analysis.

RESULTS

There were 93 intubations using the reusable VL devices and 81 intubations using the i-view. Our study was stopped early due to futility in reaching our predetermined non-inferiority margin. Operator and patient characteristics were similar between the two groups. The first-pass success rate for the i-view group was 69.1% compared to 84.3% for the reusable VL group. A non-inferiority analysis indicated that the difference (-15.1%) and corresponding 90% confidence limits (-25.3% to -5.0%) did not fall within the predetermined 10% non-inferiority margin.

CONCLUSIONS

The i-view device failed to meet our predetermined non-inferiority margin when compared to the reusable VL systems with the study stopping early due to futility. Significant crossover occurred at the discretion of the intubating operator during the i-view month.

摘要

简介

视频喉镜(VL)技术可提高首次插管成功率。新型 i-view VL 设备价格低廉且一次性使用。我们旨在确定 i-view VL 设备与每个站点常规使用的标准可重复使用 VL 系统相比的首次插管成功率。

方法

当使用 VL 时,我们在两个主要急诊科(ED)进行了前瞻性、实用研究。根据预先制定的计划,我们将 i-view 与可重复使用的 VL 作为当月首选设备进行轮换。进行了研究者发起的中期分析。我们的主要结局是根据方案分析,以 10%的非劣效性边界得出首次插管成功率。

结果

使用可重复使用的 VL 设备进行了 93 次插管,使用 i-view 进行了 81 次插管。由于达到预定非劣效性边界的无效性,我们提前停止了研究。两组操作者和患者的特征相似。i-view 组的首次插管成功率为 69.1%,而可重复使用的 VL 组为 84.3%。非劣效性分析表明,差异(-15.1%)及其相应的 90%置信区间(-25.3%至-5.0%)不在预定的 10%非劣效性边界内。

结论

与可重复使用的 VL 系统相比,i-view 设备未能达到我们预定的非劣效性边界,由于无效性,研究提前停止。在 i-view 月,根据插管操作者的判断,出现了明显的交叉。

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