Introduction Failure to secure an airway during general anesthesia is a major cause of adverse events (AEs) in children. The safety of peddiatric anesthesia may be improved by identifying the incidence of AEs and their attributed risk factors. However, previous large cohort studies have not been appropriately designed to explore such aspects. Thus, this study aims to deternine the incidence of AEs and the risk factors attributed to airway management under general anesthesia in children. Methods and design This prospective, multi-center, registry-based, observational study will be conducted in four tertiary care hospitals in Japan from June 2022 to May 2025. Children younger than 18 years of age undergoing surgical and/or diagnostic test procedures under general anesthesia or sedation by anesthesiologists will be enrolled in this study. Data on patient characteristics, discipline of anesthesia providers, and methodology of airway management will be collected through a standardized verification system under monitoring by institutional research leaders among the recruited institutions to minimize the loss of collected data. The primary outcome and exposure are AEs and presence of difficult airway features with potential confounders, which are related to the failure to secure the airway, and the variability in the anesthesia providers’ levels, adjusted using hierarchical multivariable regression models with mixed effects. Discussion This study will determine the incidence of AEs and the risk factors related to airway management under general anesthesia in children. Trial registration This study is registered as a prospective observational study in the University hospital Medical Information Network (UMIN) (registration number UMIN000047351, April 1, 2022).

The authors have declared no competing interest.

TK received a Grants-in-Aid for Scientific Research for this research (Kakanhi Grant) (grant number: 22K09085, April 1, ). URL:https://www.jsps.go.jp/j-grantsinURL: The sponsor has no relation to the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocol was reviewed and approved by the institutional review board at Aichi Children’s Health and Medical Center (approval number 2021051, September 29, 2021) and local ethical approval will be obtained from each recruited institution before initiating data collection. The institutional review board considered that written consent could be waived by performing the opt-out procedure in the current clinical study.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.