Epidemiology of adverse events attributed to airway management in pediatric anesthesia: A protocol for a Japan Pediatric Difficult Airway in Anesthesia study (J-PEDIA)

Abstract

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 Prevalence of Difficult Airway and Associated Risk Factors in Pediatric Patients: A Cross-sessional Observational Study

“…A prospectively, multicenter, registry-based study is ongoing in Japan, data not published yet. 26 Our data show the prevalence of difficult airways is significantly higher in patients of younger age, higher ASA classification grade, and presented for craniofacial and thoracic surgery. Further multivariable logistic regression reveals that age and type of surgery are the independent risk factors for difficult airways in pediatric patients.…”

“…Ideally, a long-term multicenter airway registry should be used to get a better picture. 19,25,26,31 However, there is no difficult airway registry in China till now.…”

“…The craniofacial soft tissue and bone structure differences between different races/ethnicities 11–13 may lead to different epidemiological data. A prospectively, multicenter, registry-based study is ongoing in Japan, data not published yet 26 …”

Registries in pediatric anesthesiology: A brief history and a new way forward

“…Recognizing that the findings from registries can be population-specific, investigators recently proposed creation of a Japanese pediatric difficult airway registry. 16 Similarly, findings from high-income countries may not be generalizable to low-and middle-income countries.…”

“…Generalizability is improved through the participation of multiple institutions and can include international collaboration; however, the strength of this generalizability depends on the composition of participating centers. Recognizing that the findings from registries can be population‐specific, investigators recently proposed creation of a Japanese pediatric difficult airway registry 16 . Similarly, findings from high‐income countries may not be generalizable to low‐ and middle‐income countries.…”