Prospective Development and Validation of an Objective Classification for Difficult Facemask Ventilation: the MASCAN Score - Secondary Analysis of the Prospective Observational MASCAN Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Difficult facemask ventilation
研究概览
简要总结
Difficult facemask ventilation remains poorly classified. Existing definitions rely on expert opinion and subjective rating of surrogates. This lack of standardization has led to highly variable reported incidences and inconsistencies in clinical practice and research.
This secondary analysis of the prospective observational MASCAN study aims to develop and validate a data-driven objective classification system for difficult facemask ventilation and to determine its diagnostic performance and calibration. Facemask ventilation was facilitated after anaesthesia induction in all patients. An independent observer systematically assessed potential indicators for difficult facemask ventilation that serve as candidate predictor variables for the fitting of a diagnostic multivariable logistic regression model and simplified score to classify difficult facemask ventilation. Cross-validated LASSO regression will be used for variable selection. The area under the receiver operating characteristic curve (AUROC) and calibration curves will be used to quantify the diagnostic performance and calibration, and optimal decision thresholds will be defined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients scheduling for ENT or OMS surgery in general anaesthesia, who require facemask ventilation and tracheal intubation after induction of anesthesia
- •Patients aged at least 18 years
- •Ability to understand the patient information and to personally sign and date the informed consent to participate in the study
- •The patient is co-operative and available for the entire study
- •Provided informed consent/patient representative
排除标准
- •Pregnant or breastfeeding woman
- •Rapid sequence induction or other contraindications for facemask ventilation
- •Planned awake tracheal intubation
结局指标
主要结局
Difficult facemask ventilation
时间窗: 1 hour
Alert documented in patients' health records by the airway operator following facemask ventilation (y/n)
次要结局
- Impossible facemask ventilation(1 hour)
- Airway-related adverse events(1 hour)
