PRE-CLINICAL TESTING OF A MECHANICAL VENTILATION PROTOTYPE FOR EMERGENCY PANDEMIC SITUATION, COVID-19

Abstract

Introduction: Serious cases of COVID-19 require mechanical ventilation. The performance and safety of a Mechanical Ventilator prototype for the pandemic emergency situation of COVID-19 was evaluated. Methods: In vivo experimental protocol, the animals were admitted to two Mechanical Pulmonary Ventilation (MPV) equipment, which were also configured and the respiratory and hemodynamic indicators were monitored every 30 minutes for a total time of 2 hours. The statistical analysis was based on hypothesis tests to compare means, with a significance level of 5%, and TOST to estimate equivalence between samples, with an equivalence index of 10%. Results: Admitting ranges of ± 10% for tidal volume (VC), ± 2cmH2O for PEEP, ± 2cmH2O for plateau pressure (PLATO), ± 3cmH2O for driving pressure, ± 0.4L / min for minute volume (VMIN), it is obtained, for each variable, equivalence intervals totally contained within the admitted range, which indicates the equivalence between the MPV. The variables peak pressure, VC, VMIN, PEEP, peak inspiratory flow, dynamic compliance, PLATO, SpO2, PH, PaO2, PaCO2, HCO3 and systolic blood pressure, showed similar behavior between MPV, regardless of the ventilated animal. Conclusions: There was a similarity in the performance of the VPM prototype. There is equivalence in the measurement of ventilatory mechanics of minute volume, dynamic compliance, plateau pressure and driving pressure. Conformity between SpO2 and parity in arterial blood gases (Ph, PaO2, PaCO2 and HCO3). There was no uncontrollable hemodynamic instability. Therefore, the use of PNEUMA / UFG is indicated as an alternative PMV for the pandemic situation of COVID-19, as it complies with the minimum characteristics required by Technical Standards.