视频喉罩用于甲状腺手术中可视化喉返神经监测

文献信息

中文摘要

目的： 评估视频可弯曲喉罩（VFLMA）在甲状腺手术中同时实现通气和直接可视化喉返神经（RLN）监测的可行性。
方法： 这项前瞻性单臂研究连续纳入104例接受甲状腺手术的患者，在麻醉诱导后由VFLMA提供实时声门视野。主要结局为在RLN监测下成功通气。次要结局包括可视化RLN监测（刺激后声带运动）的诊断效能以及围手术期呼吸不良事件。
结果： 104例患者中有98例（94.2%）实现了在RLN监测下的有效通气。6例患者（5.8%）需要转为气管插管，其中仅2例（1.9%）发生在手术期间。在137条监测的RLN中，7条（5.1%）出现信号丢失，并与术后暂时性声带麻痹相关；观察到的敏感性、特异性和预测值均为100%（由于事件数少，95%置信区间较宽）。按意向性分析（n=104），暂时性通气障碍的发生率分别为21.2%（气道压升高）、8.7%（反射性喉痉挛）和1.9%（暂时性漏气），均通过简单措施得到解决。术后咽喉疼痛和吞咽痛为轻度，大多数患者在1周内缓解。
结论： 在这项探索性可行性研究中，VFLMA能够在甲状腺手术期间实现直接可视化RLN监测，且通气成功率可接受。这些初步发现具有假设生成性，需要在比较性研究中加以验证。在适当选择患者的情况下，VFLMA可能为RLN监测提供一种替代方法。
试验注册： 该研究已在www.chictr.org.cn注册（注册号：ChiCTR2500105012）。

英文摘要

OBJECTIVE: To evaluate the feasibility of a video flexible laryngeal mask airway (VFLMA) for simultaneous ventilation and direct visual RLN monitoring during thyroid surgery.
METHODS: This prospective single-arm study enrolled 104 consecutive patients undergoing thyroid surgery, in whom the VFLMA provided real-time glottic views after induction. The primary outcome was successful ventilation with RLN monitoring. Secondary outcomes included diagnostic performance of visual RLN monitoring (vocal cord movement upon stimulation) and perioperative respiratory adverse events.
RESULTS: Effective ventilation with RLN monitoring was achieved in 98 of 104 patients (94.2%). Six patients (5.8%) required conversion to endotracheal intubation with only 2 (1.9%) occurring during surgery. Among 137 monitored RLNs, loss of signal occurred in 7 (5.1%) and correlated with transient postoperative vocal fold palsy; observed sensitivity, specificity, and predictive values were 100% (95% CIs wide due to few events). Transient ventilatory disturbances occurred in 21.2% (elevated airway pressure), 8.7% (reflex laryngospasm), and 1.9% (transient air leakage) on ITT analysis (n = 104), all resolved with simple measures. Postoperative throat pain and odynophagia were mild and resolved within 1 week in most patients.
CONCLUSIONS: In this exploratory feasibility study, the VFLMA enabled direct visual RLN monitoring during thyroid surgery with an acceptable ventilation success rate. These preliminary findings are hypothesis-generating and require validation in comparative studies. With appropriate patient selection, the VFLMA may offer an alternative approach for RLN monitoring.
TRIAL REGISTRATION: The study was registered at www.chictr.org.cn (Identifier: ChiCTR2500105012).