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

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 (V(T)) 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 V(T) in the simulated models were marginally different (largest difference 33 ml [95%–confidence interval (CI) 31–36]; P < .001 ml). Plateau pressure (P(plat)) was not different (–0.3 cmH(2)O [95%–CI –0.9 to 0.3]; P = .409), and positive end-expiratory pressure (PEEP) was marginally different (0.3 cmH(2)O [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 P(plat) of 15 and 30 cmH(2)O, 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.