Browsing by Author "J. M. Alonso-Iñigo"

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    Pre-clinical validation of a turbine-based ventilator for invasive ventilation–The ACUTE-19 ventilator
    (2021-01-01) 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; 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
    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.