A Pilot and Feasibility Study of a Four-Stage Neurological Staging Framework in Pediatric Tracheal Extubation During...

Postoperative tracheal extubation is a particularly high-risk period in pediatric anesthesia. Because emergence from anesthesia is a complex and complicated process, determining the optimal timing for safe tracheal extubation remains challenging.

To evaluate the feasibility and descriptive characteristics of a four-stage neuroanatomical framework for pediatric anesthesia emergence while providing exploratory incidence estimates of respiratory adverse events across these stages.

Children younger than 7 years undergoing general anesthesia were enrolled. Emergence stratified into four stages, defined by cranial nerve indicators: Stage 1 (Medulla: regular breathing, movement, excluding cough or swallowing); Stage 2 (Pons: tearing or grimacing); Stage 3 (Midbrain: conjugate gaze or eye-opening); and Stage 4 (Cerebrum: purposeful movement). Primary outcomes included feasibility metrics-such as protocol completion, recruitment flow, and data completeness-and successful assignment of emergence stages. Exploratory descriptive statistics summarized the incidence of respiratory adverse events. Risk ratios were calculated to compare the occurrence of respiratory adverse events in intermediate (Stages 2 and 3) and cortical (Stage 4) stages.

Of the 174 patients screened, 89 completed the protocol. Overall, 153 patients provided consent (91.6% consent rate). The overall data capture rate was 58.2% (89/153), while the worksheet processing rate-adjusted for protocol-ineligible cases, such as those with supraglottic airway use-was 73.2% (112/153). Among the 89 patients analyzed, there were no missing data for key variables, and stage assignment was achieved in all cases. Respiratory adverse events were observed in 16.9% of children; descriptive analysis showed an event rate of 25.0% during Stage 2, 25.0% during Stage 3, and 11.6% during Stage 4.

While stage assignment was possible among captured cases, the predefined data capture targets were not met. This pilot study successfully identified key workflow and feasibility barriers, which establish a foundation for refining protocols in the upcoming multicenter ExPEDIA registry.

Clinical Trial Registration: jRCT 1030250099.