[Pre-clinical validation of a turbine-based ventilator for invasive ventilation-The ACUTE-19 ventilator].
Alonso-Iñigo JM., Mazzinari G., Casañ-Pallardó M., Redondo-García JI., Viscasillas-Monteagudo J., Gutierrez-Bautista A., Ramirez-Faz J., Alonso-Pérez P., Díaz-Lobato S., Neto AS., Diaz-Cambronero O., Argente-Navarro P., Gama de Abreu M., Pelosi P., Schultz MJ., open source smart breathing system ACUTE-19 investigators None.
BackgroundThe 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.MethodsValidation 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.ResultsDifferences in tidal volume in the simulated models were marginally different (largest difference 33 ml [95% CI 31 to 36]; P 2O [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 2O, respectively). The ACUTE-19 achieved optimal oxygenation and ventilation before and after acute respiratory distress syndrome induction.ConclusionsThe 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.