Publication: Pre-clinical validation of a turbine-based ventilator for invasive ventilation–The ACUTE-19 ventilator
Issued Date
2021-01-01
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ISSN
00349356
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2-s2.0-85121352556
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Mahidol University
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SCOPUS
Bibliographic Citation
Revista Espanola de Anestesiologia y Reanimacion. (2021)
Suggested Citation
J. M. Alonso-Iñigo, G. Mazzinari, M. Casañ-Pallardó, J. I. Redondo-García, J. Viscasillas-Monteagudo, A. Gutierrez-Bautista, J. Ramirez-Faz, P. Alonso-Pérez, S. Díaz-Lobato, A. S. Neto, O. Diaz-Cambronero, P. Argente-Navarro, M. Gama de Abreu, P. Pelosi, M. J. Schultz Pre-clinical validation of a turbine-based ventilator for invasive ventilation–The ACUTE-19 ventilator. Revista Espanola de Anestesiologia y Reanimacion. (2021). doi:10.1016/j.redar.2021.09.008 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/78547
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Title
Pre-clinical validation of a turbine-based ventilator for invasive ventilation–The ACUTE-19 ventilator
Other Contributor(s)
IRCCS San Martino Polyclinic Hospital
Hospital Universitari i Politècnic La Fe
Università degli Studi di Genova
Cleveland Clinic Foundation
Technische Universität Dresden
Hospital Israelita Albert Einstein
Mahidol University
Hospital General de Castellon
Nuffield Department of Medicine
Universidade de São Paulo
Universidad Cardenal Herrera-CEU
Universidad de Córdoba
Amsterdam UMC - University of Amsterdam
Nippon Gases HealthCare & Oximesa NG
Hospital Universitari i Politècnic La Fe
Università degli Studi di Genova
Cleveland Clinic Foundation
Technische Universität Dresden
Hospital Israelita Albert Einstein
Mahidol University
Hospital General de Castellon
Nuffield Department of Medicine
Universidade de São Paulo
Universidad Cardenal Herrera-CEU
Universidad de Córdoba
Amsterdam UMC - University of Amsterdam
Nippon Gases HealthCare & Oximesa NG
Abstract
Background: The severe acute respiratory syndrome-coronavirus 2 pandemic pressure on healthcare systems can exhaust ventilator resources, especially where resources are restricted. Our objective was a rapid preclinical evaluation of a newly developed turbine-based ventilator, named the ACUTE-19, for invasive ventilation. Methods: Validation consisted of (a) testing tidal volume delivery in 11 simulated models, with various resistances and compliances; (b) comparison with a commercial ventilator (VIVO-50) adapting the United Kingdom Medicines and Healthcare products Regulatory Agency-recommendations for rapidly manufactured ventilators; and (c) in vivo testing in a sheep before and after inducing acute respiratory distress syndrome by saline lavage. Results: Differences in tidal volume in the simulated models were marginally different (largest difference 33 ml [95% CI 31 to 36]; P < .001). Plateau pressure was not different (−0.3 cmH2O [95% CI −0.9 to 0.3]; P = .409), and positive end-expiratory pressure was marginally different (0.3 cmH2O [95% CI 0.2 to 0.3]; P < .001) between the ACUTE-19 and the commercial ventilator. Bland-Altman analyses showed good agreement (mean bias −0.29 [limits of agreement 0.82 to −1.42], and mean bias 0.56 [limits of agreement 1.94 to −0.81], at a plateau pressure of 15 and 30 cmH2O, respectively). The ACUTE-19 achieved optimal oxygenation and ventilation before and after acute respiratory distress syndrome induction. Conclusions: The ACUTE-19 performed accurately in simulated and animal models yielding a comparable performance with a VIVO-50 commercial device. The ACUTE-19 can provide the basis for the development of a future affordable commercial ventilator.