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

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.

• Authors: 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, open source smart breathing system ACUTE-19 investigators
• Journal: Revista espanola de anestesiologia y reanimacion (Rev Esp Anestesiol Reanim (Engl Ed)) Vol. 69 Issue 9 Pg. 544-555 (Nov 2022) ISSN: 2341-1929 [Electronic] Spain
• PMID: 36244956 (Publication Type: Journal Article)
• Copyright: Copyright © 2021 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Topics

• Sheep
• Animals
• Noninvasive Ventilation
• COVID-19 (therapy)
• Ventilators, Mechanical
• Tidal Volume
• Respiratory Distress Syndrome (therapy)
• SARS-CoV-2