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视频喉镜引导下左侧卧位双腔支气管插管用于胸腔镜手术:一项开放标签随机非劣效性试验

Video laryngoscope-guided double-lumen tube tracheal intubation in the left-lateral position for thoracoscopic surgery: an open-label randomized non-inferiority trial.

临床研究咽喉科IF 2Q3

文献信息

中文摘要

目的: 评估视频喉镜引导下左侧卧位双腔支气管导管(DLT)插管是否优于仰卧位插管。
方法: 一项前瞻性、单中心、开放标签、随机、非劣效性试验纳入2022年7月至2025年9月期间在左侧卧位下接受胸腔镜右肺手术的94例患者(年龄18-75岁)。患者被随机分配接受侧卧位或仰卧位DLT插管。主要结局为总插管时间(TNI),非劣效性界值(δ)为10秒。次要结局包括首次插管成功率、Cormack-Lehane评分、DLT调整次数、患者体位准备时间、体位摆放所需医务人员数量以及辅助操作次数。同时记录安全性结局。
结果: 所有患者均首次插管成功。侧卧位的TNI比仰卧位长7秒(97.5% CI,3至10)。与仰卧位组相比,侧卧位组所需的插管调整次数更少,体位摆放准备时间更短,体位摆放所需医务人员更少,且侧卧位组DLT错位更常见(P = 0.006)。此外,连续术后评估显示,两组气道不适(以NRS测量)均在拔管后6小时达到峰值。综合临床评估表明,侧卧位显著降低了气道管理难度评分,同时保持相当的操作顺畅指数,证实了其临床效率和可行性。
结论: 视频喉镜引导下左侧卧位DLT插管在操作可行性方面不劣于仰卧位。

英文摘要

OBJECTIVE: To evaluate whether double-lumen tube (DLT) intubation guided by video laryngoscope in the left-lateral position is superior to that in the supine position.
METHODS: A prospective, single-center, open-label, randomized, non-inferiority trial included 94 patients (aged 18-75 years) undergoing thoracoscopic right lung surgery in the left position from July 2022 to September 2025. Patients were randomized to receive DLT intubation in the lateral or supine position. The primary outcome was total intubation time (TNI), with a non-inferiority margin (δ) of 10s. Secondary outcomes included first-attempt intubation success, Cormack-Lehane score, number of DLT adjustments, preparation time for patient positioning, number of medical staff required for positioning, and number of facilitating maneuvers. Safety outcomes were also recorded.
RESULTS: All patients were successfully intubated on the first attempt. TNI in the lateral position was 7 s (97.5% CI, 3 to 10) longer than that in the supine position. Compared with the supine group, the lateral group required fewer intubation adjustments, had a shorter preparation time for postural placement, had fewer medical staff personnel for postural placement, and intubation misplacement of the DLT was more common in the lateral group (P = 0.006). Furthermore, serial postoperative assessment revealed that airway discomfort (measured by NRS) peaked at 6 hours after extubation in both groups. Comprehensive clinical evaluation demonstrated that the lateral position significantly reduced the airway management difficulty score, while maintaining a comparable procedure smoothness index, confirming its clinical efficiency and feasibility.
CONCLUSION: Video laryngoscope-guided DLT intubation in the left lateral position was non-inferior to the supine position in terms of operational feasibility.