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

Fecha de publicación: 01/11/2022 Fecha Ahead of Print: 13/10/2022

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

Casañ-Pallardó M
Redondo-García JI
Viscasillas-Monteagudo J
Gutierrez-Bautista A
Ramirez-Faz J
Alonso-Pérez P
Díaz-Lobato S
Neto AS
Gama de Abreu M
Pelosi P
Schultz MJ
open source smart breathing system ACUTE-19 investigators

Grupos

Medicina Perioperatoria, Anestesiología y Reanimación

Leader

Óscar Díaz Cambronero

Abstract

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 (VT) 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 VT in the simulated models were marginally different (largest difference 33ml [95%-confidence interval (CI) 31-36]; P<.001ml). Plateau pressure (Pplat) was not different (-0.3cmH2O [95%-CI -0.9 to 0.3]; P=.409), and positive end-expiratory pressure (PEEP) 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 Pplat of 15 and 30cmH2O, 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.

Datos de la publicación

ISSN/ISSNe:: 2341-1929, 2341-1929
Tipo:: Article
Páginas:: 544-555
DOI:: 10.1016/j.redare.2021.09.006

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Métricas

Filiaciones

Alonso-Iñigo JM:: Research Group in Perioperative Medicine, Department of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario y Politécnico la Fe, Valencia, Spain
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:: T Fabrication S. L., Alicante, Spain
Díaz-Lobato S:: 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
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:: Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand

Nuffield Department of Medicine, University of Oxford, Oxford, UK

Keywords

Aumento de la capacidad médica; Bench study; COVID-19; Estudio de banco; Mechanical ventilation; Medical capacity surge; Rendimiento del ventilador; SARS-CoV-2; Ventilación mecánica; Ventilator performance