Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Unicentric)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Distance from skin to epiglottis measured with lineal ultrasound probe
研究概览
简要总结
This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.
详细描述
Tracheal intubation is a routine procedure in anaesthesia and critical care; however, difficulties during videolaryngoscopy may still occur despite advances in airway devices. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decisions, such as blade selection or anticipation of adjunct use.
This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.
The primary objective is to develop and internally evaluate a predictive model integrating multimodal data to support videolaryngoscopy strategy planning. The model is intended solely as a research and decision-support tool and does not replace clinician judgement. External validation in independent cohorts is planned.
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
结局指标
主要结局
Distance from skin to epiglottis measured with lineal ultrasound probe
时间窗: 5 minutes
Distance from skin to Hyoid bone measured with lineal ultrasound probe
时间窗: 5 minutes
Tongue Thickness measured with convex probe
时间窗: 5 minutes
Distance from Jaw to Hyoid bone distance measured with convex probe
时间窗: 5 minutes
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.(1minute)
- Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended(1minute)
- 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(1minute)
- Interincisor distance DIstance in centimeters between fornt incisors(1minute)
- neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured(1minute)
- 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(1minute)