PEACH in Asia: PEri-Anesthetic morbidity in CHildren in Asia: A prospective multinational multicenter observational study to investigate epidemiology of severe critical events in pediatric anesthesia in Asia

Abstract

BackgroundDespite the introduction of better structured programs for pediatric anesthesia training and the development of some recommendations for pediatric anesthesia services, the incidence of severe critical events in children is still unknown in Asia. Considering that the major life threatening complications following general or regional anesthesia are uncommon, it is therefore crucial to consider a large multinational, multicenter trial in order to establish a realistic statistical estimation and identify the risk factors for severe critical events.Trial Objective and PurposeThe aims of the PEACH in Asia study are: (1) To establish the incidence of severe critical events in children undergoing anesthesia in Asia. (2) To describe the differences in pediatric anesthesia practice throughout Asia. (3) To study the potential impact of this variability on the occurrence of severe critical events.Type/ Design of StudyStudy Type: ObservationalObservational Model: CohortTime Perspective: Prospective(Planned) Study Start Date: 01 April 2023(Hopeful) Primary Completion Date: 03 March 2024(Hopeful) Study Completion Date: 30 September 2024This study is a prospective, descriptive study and only includes objective data collected as part of routine anesthetic care. As a consequence this study has to be referred to as an observational trial, where no intervention takes place. Apart from standardized data acquisition, no specific procedures are performed.Primary Outcome MeasuresIncidence of the following severe critical events defined as any incident occurring during and up to 60 minutes after anesthesia or sedation (PACU), requiring immediate intervention and that may lead to major disability and/or death: Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Peri-anesthetic cardiac arrest and post-anesthetic StridorSecondary Outcome Measures(1) Risk factors for the occurrence of severe critical events(2) Consequences of the critical events: irreversible damage, in-hospital mortality [Time Frame: in-hospital and up to 30 days]Sample sizeOn the basis of the European APRICOT (the rate of severe critical events: mean 5.2% [95% confidence interval (CI) 5.0-5.5] and considering the occurrence of the severe critical events studied in several Asian countries (all are single-center study: 3.3% in Singapore, 8.9% in India, and so on), we anticipate that a minimum of approximately 7,600 patients would provide a 95% CI of 1.0% for the overall incidence of severe critical events with an acceptable confidence width (assuming that the incidence of severe critical events is 5.2% with 95% CI of 4.7-5.7%). If we were able to recruit more patients as over 30,000, we could anticipate narrower CI such as 0.5%, assuming that the incidence of severe critical events is 5.2% with 95% CI of 5.0-5.5% as the European APRICOT. Thus, we plan to recruit at least 7,600 children over a period of two consecutive weeks including weekends and after-hours across the 15 Asian countries and regions represented at the Asian Society of Pediatric Anesthesiologists Council or part of geographical Asia. The 2-week recruitment period will be chosen by each site commencing on 01 April 2023 (as planned). The last possible inclusion date will be decided by the Study Steering Committee depending on the recruitment rate.StatisticsDescriptive statistical analysis will be performed for the primary endpoint (occurrence of severe critical events and 95% confidence interval). Univariate and multivariate analysis will be performed to test factors associated with the endpoint. Results of logistic regression will be reported as adjusted odds ratio (OR) with 95 % confidence intervals.DiscussionThis international prospective observational multicenter observational study is designated to identify the incidence and potential risk factors of severe critical events in children undergoing anesthesia and sedation in Asia, which will work as a powerful road map to develop and implement data driven pediatric surgery and anesthesia plans in Asia.Trial RegistrationThis study is registered as an international prospective observational multicenter observational study in the University hospital Medical Information Network (UMIN) (UMIN Clinical Trials Registry identifier # UMIN000046328: registered on December 28th, 2021)