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

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

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)

Abstract

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.
Original languageEnglish
JournalRevista Espanola de Anestesiologia y Reanimacion
Volume69
Issue number1
DOIs
Publication statusPublished - 1 Jan 2021

Keywords

  • Bench study
  • COVID-19
  • Mechanical ventilation
  • Medical capacity surge
  • SARS-CoV-2
  • Ventilator performance

Cite this