Artificial Intelligence-Assisted Ultrasound Confirmation of Laryngeal Mask Airway Placement Using Fiberoptic Assessment as the Reference Standard: A Prospective Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Discrimination of Optimal Versus Suboptimal LMA Placement by the Multimodal Artificial Intelligence Model
研究概览
简要总结
This prospective observational study aims to develop and evaluate artificial intelligence-based models for the assessment of laryngeal mask airway (LMA) placement in adult patients undergoing elective surgery under general anesthesia. Following LMA insertion, standardized airway ultrasound images will be obtained and fiberoptic assessment will be performed as the anatomical reference standard. Fiberoptic findings will be classified as optimal (Brimacombe grades 3-4) or suboptimal (grades 1-2). Clinical and quantitative airway ultrasound variables will also be recorded. The predictive performance of tabular, image-only, and multimodal artificial intelligence models will be evaluated for identifying optimal versus suboptimal LMA placement.
详细描述
Laryngeal mask airways are widely used for supraglottic airway management during general anesthesia. Although adequate ventilation can usually be achieved after insertion, satisfactory clinical ventilation does not necessarily indicate optimal anatomical placement. Fiberoptic assessment provides direct visualization of the relationship between the LMA and laryngeal structures but is invasive and not routinely available in all clinical settings.
Airway ultrasonography provides a non-invasive bedside method for evaluating LMA position. In this prospective observational study, standardized post-placement ultrasound images will be obtained in adult patients undergoing elective surgery with an LMA. Fiberoptic assessment will subsequently be performed and graded according to the Brimacombe fiberoptic scoring system. Grades 3-4 will constitute optimal placement and grades 1-2 suboptimal placement.
Three prediction approaches are planned. Model A will use prespecified clinical and quantitative ultrasound variables, including age, sex, body mass index, Mallampati class, mouth opening, thyromental distance, neck circumference, dentition status, tongue thickness, skin-to-epiglottis distance, and the hyomental distance ratio. Model B will use post-placement ultrasound images alone using a transfer-learning-based image model. Model C will integrate ultrasound image features with the prespecified tabular variables in a multimodal prediction model.
Model performance will be assessed using patient-level resampling procedures. The primary performance measure will be the area under the receiver operating characteristic curve (AUROC), with additional assessment of sensitivity, specificity, positive and negative predictive values, F1 score, precision-recall performance, and calibration. Images obtained from the same participant will remain within the same data partition to prevent information leakage
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing elective surgery under general anesthesia in whom LMA use is clinically planned; ASA physical status I-III; ability to provide written informed consent.
排除标准
- •Emergency surgery; pregnancy; anticipated difficult airway; major upper airway or neck anatomical abnormality or previous major neck surgery; clinically significant aspiration risk or contraindication to LMA use; inability to obtain adequate ultrasound images or fiberoptic assessment.
结局指标
主要结局
Discrimination of Optimal Versus Suboptimal LMA Placement by the Multimodal Artificial Intelligence Model
时间窗: During the intraoperative assessment following LMA insertion, approximately within 15 minutes after placement
The ability of the multimodal artificial intelligence model combining post-placement ultrasound images with prespecified clinical and quantitative ultrasound variables to discriminate optimal from suboptimal LMA placement, using fiberoptic assessment as the reference standard. Optimal placement will be defined as Brimacombe grades 3-4 and suboptimal placement as grades 1-2. Model discrimination will primarily be quantified using the area under the receiver operating characteristic curve (AUROC).
次要结局
未报告次要终点
研究者
Gizem Demir Şenoğlu
Ass.Prof
Duzce University