TY - JOUR
T1 - Pre-clinical validation of a turbine-based ventilator for invasive ventilation–The ACUTE-19 ventilator
AU - Alonso-Iñigo, J. M.
AU - Mazzinari, G.
AU - Casañ-Pallardó, M.
AU - Redondo-García, J. I.
AU - Viscasillas-Monteagudo, J.
AU - Gutierrez-Bautista, A.
AU - Ramirez-Faz, J.
AU - Alonso-Pérez, P.
AU - Díaz-Lobato, S.
AU - Neto, A. S.
AU - Diaz-Cambronero, O.
AU - Argente-Navarro, P.
AU - Gama de Abreu, M.
AU - Pelosi, P.
AU - Schultz, M. J.
PY - 2021/1/1
Y1 - 2021/1/1
N2 - 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.
AB - 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.
KW - Bench study
KW - COVID-19
KW - Mechanical ventilation
KW - Medical capacity surge
KW - SARS-CoV-2
KW - Ventilator performance
UR - http://www.scopus.com/inward/record.url?scp=85121352556&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.redar.2021.09.008
DO - https://doi.org/10.1016/j.redar.2021.09.008
M3 - Article
C2 - 36337377
SN - 0034-9356
VL - 69
JO - Revista Espanola de Anestesiologia y Reanimacion
JF - Revista Espanola de Anestesiologia y Reanimacion
IS - 1
ER -