Development and Validation of Prediction Models for Difficult Mask Ventilation in Pediatric Anesthesia
Résumé fourni par la source
This registration describes a statistical analysis plan for a multicenter retrospective observational cohort study using the Japan Pediatric Difficult Airway in Anesthesia (J-PEDIA) database. The purpose of this study is to develop and validate prediction models for difficult mask ventilation during pediatric anesthesia using clinical variables available before or at induction of anesthesia. The analysis will include pediatric anesthetic cases from 12 participating institutions in Japan. The primary outcome is difficult mask ventilation, defined as difficulty achieving adequate ventilation despite maximal effort by a single board-certified anesthesiologist, based on insufficient chest wall movement, tidal volume less than 5 mL/kg, or absence of the phase III plateau on capnography. The study will develop a multivariable logistic regression prediction model and evaluate its discrimination, calibration, and clinically interpretable risk strata using a temporal validation cohort. Simplified clinical models and an integer point score will also be derived to support bedside risk assessment. Transportability across institutions will be evaluated using leave-one-center-out validation, and robustness will be assessed using sensitivity analyses and bootstrap optimism correction.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.