Abstract
Background and Objectives: Analgesia and sedation are a major challenge in pediatric intensive care. The COMFORT-B scale and the Bispectral Index (BIS) are commonly used to assess the degree of sedation. The aim of this study was to investigate the correlation between the COMFORT-B and BIS and to evaluate the predictive validity of the BIS scale. Materials and Methods: Mechanically ventilated children (n = 41) diagnosed with acute bronchiolitis and treated with fentanyl and midazolam were included in the study. COMFORT-B and BIS scores were recorded over a 7-day observation period. Patients were divided into subgroups based on chronological age, neuromuscular blocker use, and level of sedation. Statistical analyses included correlation analysis by subject and time, simple moving average trend analysis, linear mixed-effects modeling and random forest. Results: Conventional correlation analysis revealed a weak to moderate correlation between the two scales in the entire cohort (Spearman rho of patients' means 0.42, p = 0.007). The longitudinal correlation analysis by individual patient showed no significant relationship between the two scales in the entire cohort (CCF 0-lag 0.23; p = 0.33) or any subgroup. Linear mixed-effects model analysis showed that BIS score was associated with COMFORT-B score (slope = 0.799, p = 0.0002). The random forest model explained 19.6% of the variance. Both models yielded similar prediction errors (RMSE 10.6 and 11.3, respectively). Conclusions: We found a weak correlation between the two scales, which does not allow for reliable and valid predictions between the two scales. The BIS scale is suitable for the assessment of deep sedation, whereas the COMFORT-B scale is suitable for the assessment of moderate sedation.