Manikin-based noninferiority simulation study of Airgency™: A novel automatic bag valve mask device for emergency respiratory support.

OBJECTIVES

This study evaluated the performance of Airgency™, an automated bag valve mask (BVM) ventilation device developed by Institut Teknologi Bandung and Padjadjaran University, Indonesia, using a manikin-based simulation model. Its performance was compared with conventional hand-squeezed bagvalvemask ventilation performed by medical professionals, with a focus on reducing operator-dependent variability and fatigue.

METHODS

A manikin-based simulation was conducted using an adult airway trainer connected to a lung simulator (ASL5000) set to mimic apneic respiratory failure with normal lung mechanics. The Ambu bag, connected to 15 L/min oxygen, was secured to the manikin. Airgency™ operated in normal mode (tidal volume [VT] 400 mL, 15 bpm) for 30 min, repeated 50 times. Seventy-eight anesthesiology residents performed manual BVM ventilation under identical conditions after standardized training. Breathing rate (BR), VT, and peak inspiratory pressure (PIP) were recorded every minute, whereas fatigue was rated using the Visual Analog Scale for Fatigue (VAS-F, 1-10).

RESULTS

Airgency™ demonstrated superior ventilation stability. BR remained consistent (14.77 ± 0.08 vs. 16.54 ± 7.05 bpm; P < 0.0001), with much lower variability (coefficient of variation [CV] 0.47% vs. 46.1%-121.2%). VT delivery was steady (397.8 ± 3.1 vs. 406.9 ± 85.4 mL; P < 0.0001; CV 2.2% vs. 13.9%-25.7%), and PIP was more uniform (29.4 ± 0.9 vs. 23.1 ± 8.2 cmH2O; P < 0.00001; CV 2.5% vs. 28.3%-41.1%). Operator fatigue increased progressively during manual ventilation (VAS-F 1.83-5.09; P < 0.0001).

CONCLUSION

Airgency™ maintained consistent, precise ventilation with minimal variability and eliminated operator fatigue, supporting its potential as a reliable alternative to manual BVM ventilation in emergency care.