Protocol development and feasibility of the PEACH in Asia study: A pilot study on PEri-anesthetic morbidity in CHildren in Asia.

Abstract

Background: Comprehensive data on pediatric anesthesia outcomes, particularly severe critical events (SCEs), are scarce in Asia. This highlights the need for standardized research to assess anesthesia safety and quality in the diverse settings.

Aims: The PEACH in Asia pilot study aimed to test the feasibility of a standardized protocol for investigating SCEs in anesthesia practices across Asia, evaluate the data acquisition processes, and determine the sample size for a main study.

Methods: This multicenter pilot study involved ten institutions across nine Asian countries, including children from birth to 15 years undergoing diagnostic or surgical procedures. Data on SCEs were collected using standardized definitions. The study assessed the feasibility and estimated the sample size needed for the main study.

Results: The pilot study enrolled 330 patients, with a SCE incidence of 12.4% (95% CI: 9.2-16.4%). Respiratory events were observed in 7.0% of cases, cardiovascular instability in 4.9%, and drug errors in 0.6%. Based on the SCE incidence observed in the pilot study, the estimated sample size required for the main study is at least 10 958 patients. The pilot study demonstrated the feasibility of the study protocol but identified several challenges, particularly in resource-limited settings. These challenges included a significant burden associated with data collection, technical issues with electronic case report forms (e-CRFs), variability in patient enrollment across institutions (ranging from 4 to 86 patients per site), and incomplete data acquisition (24.8% of height data and 9.7% of disposition data were missing).

Conclusions: The PEACH in Asia pilot study successfully validated a protocol for investigating SCEs in pediatric anesthesia across Asia. Addressing the challenges identified in the pilot study will be crucial for generating robust data to improve pediatric anesthesia safety in the region. Key issues to address include improving data collection methods, resolving e-CRF technical difficulties, and ensuring consistent institutional support.