泰国成年全身麻醉患者面罩通气期间需要气道辅助装置预测因素的前瞻性观察性研究

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中文摘要

背景： 面罩通气是全身麻醉期间气道管理的基石，然而当前术前评估对面罩通气期间是否需要气道辅助装置的预测能力仍然较差。我们旨在识别接受择期手术的泰国成年人中该结局的独立临床预测因素。
方法： 这项单中心前瞻性观察性研究纳入2018年9月至2019年10月在泰国一所大学医院接受择期全身麻醉的266名成年人。术前气道评估包括Mallampati分级、牙列状况、颈围、打鼾或阻塞性睡眠呼吸暂停（OSA）病史以及其他标准变量。主要结局是面罩通气期间需要气道辅助装置或优化，定义为Han分级≥2。选择Han分级≥2是因为在Han分级≥3的定义下仅发生10例3级事件，导致每变量事件数为2.5，不足以进行可靠的多变量回归。采用多变量logistic回归并结合向后逐步消除法识别独立预测因素。通过受试者工作特征（ROC）分析和曲线下面积（AUC）评估仅颈围以及完整四变量模型的区分能力。通过在每个重抽样内重复模型构建过程（包括单变量筛选和向后逐步消除），进行Bootstrap内部验证（1,000次重抽样）。
结果： 需要气道辅助装置（Han分级≥2）发生于48名患者（18.0%）；38名（14.3%）为Han分级2，10名（3.8%）为Han分级3。多变量logistic回归分析显示，四个变量与需要气道辅助装置独立相关：打鼾或OSA（aOR 5.27，95% CI 1.94-14.35）、缺失≥2颗上切牙（aOR 2.30，95% CI 1.08-4.89）、颈围≥35 cm（aOR 3.02，95% CI 1.42-6.44）以及Mallampati III-IV级（aOR 2.47，95% CI 1.22-4.97）。最终四变量模型的表观AUC为0.804（95% CI 0.745-0.862）。采用1,000次重抽样并在每个重抽样内重复模型构建过程的Bootstrap内部验证显示，平均乐观度为0.040，乐观度校正后的AUC为0.764（95% bootstrap区间0.708-0.820）。Hosmer-Lemeshow拟合优度检验未显示模型拟合不良的证据（P = 0.077）。一个简单的床旁整数风险评分（0-5分）的AUC为0.801。在探索性截断值≥3时，敏感性为0.85，特异性为0.63，PPV为0.34，NPV为0.95。
结论： 打鼾或OSA、颈围≥35 cm、Mallampati III-IV级以及缺失≥2颗上切牙与泰国成年患者面罩通气期间需要气道辅助装置独立相关。所有四个预测因素均可在床旁无需额外设备进行评估，提示可将其整合到常规术前气道评估中。作为一项单中心推导研究，这些发现具有假设生成性质，在临床采用前需要在独立的东南亚队列中进行外部验证。

英文摘要

BACKGROUND: Mask ventilation is a cornerstone of airway management during general anesthesia, yet the need for airway adjuncts during mask ventilation remains poorly predicted by current preoperative assessments. We aimed to identify independent clinical predictors of this outcome in Thai adults undergoing elective surgery.
METHODS: This single-center prospective observational study included 266 adults undergoing elective general anesthesia at a university hospital in Thailand between September 2018 and October 2019. Preoperative airway assessment included Mallampati classification, dentition status, neck circumference, history of snoring or obstructive sleep apnea (OSA), and other standard variables. The primary outcome was the need for airway adjuncts or optimization during mask ventilation, defined as Han grade ≥2. Han grade ≥2 was selected because only 10 grade-3 events occurred, yielding an events-per-variable ratio of 2.5 under the grade ≥3 definition - insufficient for reliable multivariable regression. Independent predictors were identified using multivariable logistic regression with backward stepwise elimination. Discriminative ability was evaluated using receiver operating characteristic (ROC) analysis and area under the curve (AUC) for both neck circumference alone and the complete four-variable model. Bootstrap internal validation (1,000 resamples) was performed by repeating the model-building procedure, including univariable screening and backward stepwise elimination, within each resample.
RESULTS: The need for airway adjuncts (Han grade ≥2) occurred in 48 patients (18.0%); 38 (14.3%) had Han grade 2 and 10 (3.8%) had Han grade 3. Four variables were independently associated with the need for airway adjuncts in the multivariable logistic regression analysis: snoring or OSA (aOR 5.27, 95% CI 1.94-14.35), absence of ≥2 upper incisors (aOR 2.30, 95% CI 1.08-4.89), neck circumference ≥35 cm (aOR 3.02, 95% CI 1.42-6.44), and Mallampati class III-IV (aOR 2.47, 95% CI 1.22-4.97). The final four-variable model had an apparent AUC of 0.804 (95% CI 0.745-0.862). Bootstrap internal validation with 1,000 resamples, repeating the model-building procedure within each resample, yielded a mean optimism of 0.040 and an optimism-corrected AUC of 0.764 (95% bootstrap interval 0.708-0.820). The Hosmer-Lemeshow goodness-of-fit test showed no evidence of poor model fit (P = 0.077). A simple bedside integer risk score (0-5 points) had an AUC of 0.801. At an exploratory cutoff of ≥3, the sensitivity was 0.85, specificity 0.63, PPV 0.34, and NPV 0.95.
CONCLUSION: Snoring or OSA, neck circumference ≥35 cm, Mallampati class III-IV, and absence of ≥2 upper incisors were independently associated with the need for airway adjuncts during mask ventilation in Thai adult patients. All four predictors can be assessed at the bedside without additional equipment, suggesting their integration into routine preoperative airway evaluation. As a single-center derivation study, these findings are hypothesis-generating and require external validation in independent Southeast Asian cohorts before clinical adoption.