Adverse events attributed to tracheal extubation in pediatric anesthesia: protocol for a multicenter prospective observational study (Ex-PEDIA; Extubation in Pediatric Anesthesia) in Japan

Abstract Background Post-anesthetic tracheal extubation can lead to critical adverse events (AEs) in children due to their intolerance to hypoxia. However, evidence from pediatric studies on the factors associated with safe tracheal extubation is limited. We will investigate the incidence and risk factors of AEs associated with tracheal extubation using real-world data from Japan. This study aims to test the following hypotheses: extubation-related AEs are associated with (a) several indicative signs of cranial nerve activity and upper airway reflexes, and (b) difficult airway features. Methods This prospective, multi-center, registry-based, cross-sectional study will be conducted at 17 hospitals in Japan from October 2025 to September 2028. It will include children aged