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

BackgroundPost-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. MethodsThis 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 <18 years undergoing surgical and/or diagnostic test procedures under general anesthesia or sedation by anesthesiologists. Data on the patient, surgery, and anaesthesia characteristics; provider discipline; airway management; and extubation methodology will be collected. The exposures of interest are the presence of clinical signs related to anesthesia emergence and features of difficult airway. The primary and secondary endpoints are AEs associated with extubation and reduced peripheral arterial oxygen saturation. Multilevel mixed-effects multivariable regression analysis will be performed to adjust for potential confounders associated with AEs attributed to extubation and variations related to the hospital type and institutional level. The required sample size was determined to be approximately 8500 based on the assumptions of a 99% probability of obtaining a 95% Wilson CI with a half-width of {+/-}0.3% and an incidence of any AE of 2.0%. DiscussionThis study is a prospective, registry-based, multicenter, cross-sectional study designed to describe the real-world incidence of AEs related to extubation and the associated risk factors in Japan. This study employs the validation system incorporating site-specific leaders and the REDCap(R) data registration system to minimize reporting and selection bias. We have conducted a pilot study to investigate feasibility and consulted research members regarding data collection and study methods. The findings will provide vital information on the risks associated with extubation-related AEs and contribute to the development of safer tracheal extubation strategies. Trail registration number: jRCT 1030250100