Pre-clinical validation of a turbine-based ventilator for invasive ventilation-The ACUTE-19 ventilator.

Autor: Alonso-Iñigo JM; Research Group in Perioperative Medicine, Department of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario y Politécnico la Fe, Valencia, Spain. Electronic address: jmalonso@me.com., Mazzinari G; Department of Anesthesia, Critical Care and Pain Medicine, Hospital General Universitario de Castellón, Castellón de la Plana, Castellón, Spain., Casañ-Pallardó M; Department of Anesthesia, Critical Care and Pain Medicine, Hospital General Universitario de Castellón, Castellón de la Plana, Castellón, Spain., Redondo-García JI; Department of Veterinary Anesthesia, Hospital Clínico Veterinario CEU, Universidad CEU Cardenal Herrera, Alfara del Patriarca, Valencia, Spain., Viscasillas-Monteagudo J; Department of Veterinary Anesthesia, Hospital Clínico Veterinario CEU, Universidad CEU Cardenal Herrera, Alfara del Patriarca, Valencia, Spain., Gutierrez-Bautista A; Department of Veterinary Anesthesia, Hospital Clínico Veterinario CEU, Universidad CEU Cardenal Herrera, Alfara del Patriarca, Valencia, Spain., Ramirez-Faz J; Department of Electrical Engineering, Universidad de Córdoba, Córdoba, Spain., Alonso-Pérez P; Department of Research and Innovation, Tecnikoa and C&T Fabrication S. L., Alicante, Spain., Díaz-Lobato S; Medical Division, Nippon Gases HealthCare & Oximesa NG, Madrid, Spain., Neto AS; Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brasil; Cardio-Pulmonary Department, Pulmonary Division, Instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brasil; Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (LEICA), Academic Medical Center, Amsterdam, The Netherlands., Diaz-Cambronero O; Research Group in Perioperative Medicine, Department of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario y Politécnico la Fe, Valencia, Spain., Argente-Navarro P; Research Group in Perioperative Medicine, Department of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario y Politécnico la Fe, Valencia, Spain., Gama de Abreu M; Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Therapy, Technische Universität Dresden, Dresden, Germany; Outcome Research Consortiu, Cleveland Clinic, Cleveland, OH, USA., Pelosi P; Policlinico San Martino Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy; Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy., Schultz MJ; Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (LEICA), Academic Medical Center, Amsterdam, The Netherlands; Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand; Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Jazyk: angličtina
Zdroj: Revista espanola de anestesiologia y reanimacion [Rev Esp Anestesiol Reanim (Engl Ed)] 2022 Nov; Vol. 69 (9), pp. 544-555. Date of Electronic Publication: 2022 Oct 13.
DOI: 10.1016/j.redare.2021.09.006
Abstrakt: Background: The Severe Acute Respiratory Syndrome (SARS)-Coronavirus 2 (CoV-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 (V T ) 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 (ARDS) by saline lavage.
Results: Differences in V T in the simulated models were marginally different (largest difference 33ml [95%-confidence interval (CI) 31-36]; P<.001ml). Plateau pressure (P plat ) was not different (-0.3cmH 2 O [95%-CI -0.9 to 0.3]; P=.409), and positive end-expiratory pressure (PEEP) was marginally different (0.3 cmH 2 O [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 P plat of 15 and 30cmH 2 O, respectively). The ACUTE-19 achieved optimal oxygenation and ventilation before and after ARDS 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.
(Copyright © 2021 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.)
Databáze: MEDLINE
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