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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.
Methods and Material: 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.
References
- BCC Publishing. Global Medical Ventilators Market Wellesley, MA: BCC Publishing; 2020.
- Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States. Crit Care Med. 2010;38:1947-53.
- Al Husseini AM, Lee HJ, Negrete J, Powelson S, Servi AT, Slocum AH, et al. Design and prototyping of a low-cost portable mechanical ventilator. J Med Device. 2010;4:27514.
- Maclean R, Simon M. 10 African Countries Have No Ventilators. 2020. That's Only Part of the Problem. The New York Times; Available from: https://www.nytimes.com/2020/04/18/world/africa/africa-coronavirus-ventilators.html [Last accessed on 2021 Oct 08]
- Rubinson L, Vaughn F, Nelson S, Giordano S, Kallstrom T, Buckley T, et al. Mechanical ventilators in US Acute Care Hospitals. Disaster Med Public Health Prep. 2010;4:199-206.
- Mantena S, Rogo K, Burke TF. Re-examining the race to send ventilators to low-resource settings. Respir Care. 2020;65:1378-81.
- Meng L, Qiu H, Wan L, Ai Y, Xue Z, Guo Q, et al. Intubation and ventilation amid the COVID-19 outbreak. Anesthesiology. 2020;132:1317-32.
- COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU) 2021. Available from: https://www.gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 [Last accessed on 2021 Oct 08]
- Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for Quality improvement reporting excellence): Revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25:986-92.
- Chatburn RL, Mireles-Cabodevila E, Tobin MJ. Basic Principles of Ventilator Design, Principles and Practice of Mechanical Ventilation (3rd ed). Chicago, IL: McGraw-Hill Companies. Inc.; 2013. p. :65-100.
- ISO. ISO 80601-2-80: 2018, Medical Electrical Equipment-Part 2-80: Particular Requirements for Basic Safety and Essential Performance of Ventilatory Support Equipment for Ventilatory Insufficiency 2018.
- Mansournia MA, Nazemipour M, Naimi AI, Collins GS, Campbell MJ. Reflection on modern methods: Demystifying robust standard errors for epidemiologists. Int J Epidemiol. 2021;50:346-51.
- Knorr J, Sheehan M, Santana D, Samorezov S, Sammour I, Deblock M, et al. Design and performance testing of a novel emergency ventilator for in-hospital use. Can J Respir Ther. 2020;56:42-51.
- Kwon AH, Slocum AH, Varelmann D, Nabzdyk CG, Araki B, Abu-Kalaf M, et al. Rapidly scalable mechanical ventilator for the COVID-19 pandemic. Intensive Care Med. 2020;46:1642-4.
- VentilAid, Ventilaid Breathing Device Mk III. 2020. Available from: https://www.ventilaid.org/ventilaid-breathing-device-mk-iii [Last Accessed on 2021 Oct 08]
- Gohd C. Virgin Orbit Designs New Ventilator as Part of Virgin Group's Efforts to Combat Coronavirus. 2020. Available from: https://www.space.com/virgin-orbit-designs-ventilator-to-fight-coronavirus.html [Last Accessed on 2021 Oct 08]
- Good A. NASA Develops COVID-19 Prototype Ventilator in 37 Days. 2020. Available from: https://www.nasa.gov/feature/jpl/nasa-develops-covid-19-prototype-ventilator-in-37-days [Last Accessed on 2021 Oct 08]
- FDA. Emergency Use Authorizations for Medical Devices. 2021. Available from: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices [Last Accessed on 2021 Oct 08]
- Raymond SJ, Wesolowski T, Baker S, Liu Y, Edmunds JL, Bustamante MJ, et al. A Low-cost, rapidly scalable, emergency use ventilator for the COVID-19 crisis. 2020
- Tsevat J, Moriates C. Value-based health care meets cost-effectiveness analysis. Ann Intern Med. 2018;169:329-32.
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Accepted: 07-04-2023
Published: 12-12-2022
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This work is licensed under a Creative Commons Attribution 4.0 International License.