Study of veterinary parameters in animals to assist in ANVISA certification of a mechanical ventilator for humans.
Mechanical ventilator;Veterinary physiotherapeutic parameters; ANVISA registration
This study aims to develop a veterinary parameter study that enables the conduction of preclinical tests of mechanical ventilators in pigs, in compliance with ANVISA requirements. The mechanical ventilator in question is a low-cost device designed to meet the emerging demand for accessible respiratory equipment during and after the Covid-19 pandemic. Pigs have been selected as the experimental model due to their physiological similarity to humans, particularly concerning the respiratory system, and their wide acceptance in ethical research protocols in Brazil. However, this study will not conduct the actual experimental tests; instead, it proposes the definition of essential parameters, such as tidal volume, inspiratory pressure, respiratory rate, and anesthetic management, that will allow for future application of the ventilator in trials with pigs. The precise definition of these parameters is crucial to ensure the safety and efficacy of the animal tests and to ensure that the results can be extrapolated for human use. The study also addresses ethical and methodological issues related to the choice of the animal model, as well as suggesting handling practices that minimize risks to pigs during procedures. By providing a detailed set of guidelines for conducting tests in pigs, this research aims to contribute to the advancement of mechanical ventilator certification, facilitating its future implementation in the clinical setting.