Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Multicentric)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Distance from skin to Hyoid bone measured with lineal ultrasound probe
研究概览
简要总结
This multicentre observational study will collect clinical parameters, demographic data, and point-of-care airway ultrasound measurements from adult patients undergoing videolaryngoscopy across participating centres. The collected data will be analysed using artificial intelligence-based analytical approaches, including statistical and machine-learning techniques, to examine their association with predefined videolaryngoscopy-related outcomes.
详细描述
Videolaryngoscopy is widely used for tracheal intubation in anaesthesia and critical care; however, variability in patient anatomy, operator experience, and institutional practice may influence videolaryngoscopy performance and strategy selection. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decision-making, particularly in diverse clinical environments.
This multicentre observational study will collect clinical parameters, demographic data, and point-of-care airway ultrasound measurements from adult patients undergoing videolaryngoscopy across participating centres. The collected data will be analysed using artificial intelligence-based analytical approaches, including statistical and machine-learning techniques, to examine their association with predefined videolaryngoscopy-related outcomes.
The primary objective is to evaluate the performance and generalisability of multimodal predictive models developed using multicentre data. The study is designed to support the development and validation of data-driven decision-support tools for videolaryngoscopy planning. These tools are intended for research purposes and do not replace clinical judgement.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.
排除标准
- •Obesity class II defined as a BMI greater than
- •Pregnant.
- •Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
- •Abnormalities that condition anatomy alterations such as facial / cervical fractures.
- •Maxillofacial abnormalities
- •People who cannot give their consent
研究组 & 干预措施
Patient undergoing general anesthesia with videolaryngoscopy intubation
Patient undergoing general anesthesia with intubation We will explore clinical airway parameters and external ultrasound parameters of the airway.
干预措施: Ultrasound mesurements (Diagnostic Test)
结局指标
主要结局
Distance from skin to Hyoid bone measured with lineal ultrasound probe
时间窗: Immediately prior to induction of anesthesia
Distance from skin to Hyoid bone measured with lineal ultrasound probe
Distance from skin to epiglottis measured with lineal ultrasound probe
时间窗: Immediately prior to induction of anesthesia
Distance from skin to epiglottis measured with lineal ultrasound probe
Tongue Thickness measured with convex probe
时间窗: Immediately prior to induction of anesthesia
Tongue Thickness measured with convex probe
Distance from Jaw to Hyoid bone distance measured with convex probe
时间窗: Immediately prior to induction of anesthesia
Distance from Jaw to Hyoid bone distance measured with convex probe
次要结局
- Modified Mallampati Score Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible.(Immediately prior to induction of anesthesia)
- Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended(Immediately prior to induction of anesthesia)
- Sternomental distance the distance from the suprasternal notch to the mentum and is measured with the head fully extended on the neck and the mouth closed(Immediately prior to induction of anesthesia)
- Interincisor distance DIstance in centimeters between fornt incisors(Immediately prior to induction of anesthesia)
- Upper Lip Bite Test upper lip bite criteria-class I = lower incisors can bite the upper lip above the vermilion line, class II = lower incisors can bite the upper lip below the vermilion line, and class III = lower incisors cannot bite the upper lip(Immediately prior to induction of anesthesia)
- neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured(Immediately prior to induction of anesthesia)