Agreement and Reliability of a Newly Developed Tidal Volume Monitoring Device in Bag-Valve Ventilation and Intubation Scenarios: A Simulation-Based Study

Background: Manual bag-valve ventilation is a fundamental intervention in prehospital and emergency care but remains highly operator-related and frequently associated with inappropriate tidal volume delivery. Excessive or insufficient ventilation may adversely affect hemodynamics and clinical outcomes. Although real-time tidal volume monitoring has the potential to improve ventilation quality, its measurement performance across different airway conditions has not been sufficiently evaluated. Methods: This simulation-based repeated-measures study evaluated the measurement agreement and reliability of a newly developed tidal volume monitoring device during manual ventilation using an adult airway management manikin. Twenty emergency medical technicians performed bag-valve ventilation across three airway scenarios: face mask ventilation, endotracheal tube (ETT) intubation, and supraglottic airway (I-gel) insertion. For each scenario, 10 repeated breaths were recorded. Tidal volumes measured by the test device were compared with simulator-derived reference values. Measurement agreement was assessed using paired t-tests, Pearson correlation coefficients, effect sizes, and Bland–Altman analysis, while measurement reliability was evaluated using intraclass correlation coefficients (ICC). Mixed repeated-measures ANOVA was performed to examine interaction effects between airway scenario and operator characteristics. Results: The test device consistently overestimated tidal volume compared with the simulator reference across all airway scenarios (p < 0.001). Correlation between measurements was weak during mask ventilation (r = 0.174) but strong during ETT (r = 0.854) and I-gel (r = 0.709) ventilation, whereas Bland–Altman analysis demonstrated wider limits of agreement in mask ventilation and narrower limits under intubated conditions. ICC analysis revealed airway-dependent reliability, with minimal agreement in normal BVM ventilation but substantially higher agreement during ET-tube and I-gel intubation. Significant effects of airway scenario and operator characteristics (gender, age group, and clinical experience level) were observed, with notable interaction effects between airway scenario and clinical experience. Conclusions: Despite systematic overestimation, the tidal volume monitoring device demonstrated consistent and repeatable performance, particularly under secured airway conditions. Its primary clinical value may lie in reducing operator-related variability and supporting safer manual ventilation through real-time feedback, rather than replacing gold-standard measurement systems. Further algorithm refinement and clinical validation are warranted.