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视频喉镜与直接喉镜用于小儿麻醉中择期气道管理的比较:一项前瞻性随机对照试验。

Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Paediatric Anaesthesia: A prospective randomised controlled trial.

机构信息

From the Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Czech Republic (E.K., J.K., M.K., M.T., R.S., M.K., L.M., P.S.), Faculty of Medicine, Masaryk University Brno, Czech Republic (E.K., J.K., M.K., M.T., R.S., M.K., L.M., P.J., M.U., P.S.), Institute of Biostatistics and Analyses Ltd., Brno, Czech Republic (M.S.), Department of Paediatric, University Hospital Brno, Czech Republic (P.J.) and Department of Paediatric ENT, University Hospital Brno, Czech Republic (M.U.).

出版信息

Eur J Anaesthesiol. 2021 Nov 1;38(11):1187-1193. doi: 10.1097/EJA.0000000000001595.

Abstract

BACKGROUND

The indirect visualisation of the glottic area with a videolaryngoscope could improve intubation conditions which may possibly lead to a higher success rate of the first intubation attempt.

OBJECTIVE

Comparison of videolaryngoscopy and direct laryngoscopy for elective airway management in paediatric patients.

DESIGN

Prospective randomised controlled trial.

SETTINGS

Operating room.

PARTICIPANTS

535 paediatric patients undergoing elective anaesthesia with tracheal intubation. 501 patients were included in the final analysis.

INTERVENTIONS

Patients were randomly allocated to the videolaryngoscopy group (n  = 265) and to the direct laryngoscopy group (n  = 269) for the primary airway management.

MAIN OUTCOME MEASURES

The first attempt intubation success rate was assessed as the primary outcome. The secondary outcomes were defined as: the time to successful intubation (time to the first EtCO2 wave), the overall intubation success rate, the number of intubation attempts, the incidence of complications, and the impact of the length of the operator's clinical practice.

RESULTS

The study was terminated after the planned interim analysis for futility. There were no significant demographic differences between the two groups. The first attempt intubation success rate was lower in the videolaryngoscopy group; 86.8% (n  = 211) vs. 92.6% (n  = 239), P = 0.046. The mean time to the first EtCO2 wave was longer in the videolaryngoscopy group at 39.0 s ± 36.7 compared to the direct laryngoscopy group, 23.6 s ± 24.7 (P < 0.001). There was no difference in the overall intubation success rate, in the incidence of complications nor significant difference based on the length of the clinical practice of the operator.

CONCLUSIONS

The first attempt intubation success rate was lower in the videolaryngoscopy group in comparison to the direct laryngoscopy group. The time needed for successful intubation with videolaryngoscopy was longer compared with direct laryngoscopy.

TRIAL REGISTRATION

Clinicaltrials.gov identifier: NCT03747250.

摘要

背景

视频喉镜间接可视化声门区可改善插管条件,可能提高首次插管尝试的成功率。

目的

比较视频喉镜与直接喉镜在小儿患者择期气道管理中的效果。

设计

前瞻性随机对照试验。

设置

手术室。

参与者

535 名接受择期全身麻醉并需气管插管的儿科患者。最终有 501 名患者纳入分析。

干预措施

患者被随机分配到视频喉镜组(n = 265)和直接喉镜组(n = 269)进行主要气道管理。

主要观察指标

首次尝试插管成功率作为主要结局。次要结局定义为:成功插管时间(首次 EtCO2 出现时间)、总体插管成功率、插管尝试次数、并发症发生率以及操作者临床实践经验的影响。

结果

在进行计划的无效性中期分析后,该研究提前终止。两组之间的人口统计学差异无统计学意义。视频喉镜组首次尝试插管成功率较低,为 86.8%(n = 211)比直接喉镜组的 92.6%(n = 239),P = 0.046。视频喉镜组首次 EtCO2 出现时间的平均值为 39.0 s ± 36.7,比直接喉镜组的 23.6 s ± 24.7 长(P < 0.001)。总体插管成功率、并发症发生率以及操作者临床实践经验的差异均无统计学意义。

结论

与直接喉镜组相比,视频喉镜组首次尝试插管成功率较低。使用视频喉镜成功插管所需时间长于直接喉镜。

试验注册

Clinicaltrials.gov 标识符:NCT03747250。

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