US Army Institute of Surgical Research, JBSA Fort Sam Houston, Texas, USA.
Brooke Army Medical Center, JBSA, JBSA Fort Sam Houston, Texas, USA.
Transfusion. 2024 May;64 Suppl 2:S201-S209. doi: 10.1111/trf.17790. Epub 2024 Mar 28.
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.
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.
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.
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.
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。
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。
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。
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。