Abstract
Objectives: The emergent need for ventilators amidst the COVID-19 pandemic has catalyzed the production of innovative ventilator designs in hopes to optimize supply, manufacturing, ease of use, and cost in disaster situations. We created a novel and low-cost ventilator called QuantumAir, which uses “choked flow” to perform volume assist-control ventilation. Material and Methods: To evaluate the efficacy and safety of QuantumAir, we tested the ventilator across eight test cases on a lung simulator, with each test case trial lasting for at least 24 breath cycles. Delivered tidal volumes, peak inspiratory pressures, and plateau pressures were measured, and linear regression models were used to assess for non-inferiority of the QuantumAir ventilator as compared to that of a Food and Drug Administration (FDA)-cleared ventilator. Results: For each of the test cases, the standard deviation for the tidal volumes delivered during the 24 measured breaths on the QuantumAir ranged from 0.11 to 0.80 mL. The QuantumAir was found to be non-inferior to the FDA-cleared ventilator for both delivered tidal volumes and plateau pressures across all test cases and non-inferior for peak inspiratory pressures in six of the eight test cases. Conclusion: Although future in vivo studies are still needed, our data shows promise to offer a more affordable solution to mechanical ventilation in resource-limited situations, as was experienced during the peak of the COVID-19 pandemic.
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