Estudo de parâmetros fisioterapêuticos para registro Anvisa de um ventilador mecânico para o tratamento da Covid-19

Abstract

The focus of this work was to research the physiotherapeutic parameters recommended by the various official health bodies in Brazil for the treatment of patients affected by the COVID-19 virus, aiming to better guide UFRN design engineers in the design and development of a low-cost portable mechanical ventilator prototype. that is effective, safe and ready to meet the minimum health requirements necessary to successfully apply for registration with ANVISA (National Health Surveillance Agency). The methodology adopted was hypothetical-deductive, approaching descriptive and applied research. As results, the tests and validation of the initial hypotheses are presented, associated with technical information on the suggested adjustments so that the ventilators meet the minimum medical-physiotherapy needs. Considering that the requirements are not limited to the health area, but also involve engineering constraints, a flowchart guide was developed addressing the bureaucratic steps and engineering standards that need to be consulted and adopted. Additionally, the contributions arising from this research culminated in the filing of a patent for the innovative low-cost equipment. It is also noteworthy that the ventilator provides, in an unprecedented way, a very important physiotherapy alarm that corresponds to the. driving pressure and which is non-existent, even in the most sophisticated commercial ventilators. This means that it has a strong potential to prevent deaths from serious lung injuries. Overall, it is concluded that a few details remain to be fulfilled concerning the medical-physiotherapy field, but are easy to implement, so that the ventilator is ready to face pre-clinical studies in animal models, followed by clinical studies in humans. Therefore, the main adjustments refer to the sound implementation of some alarms. It will be essential to include the assisted mode to use during weaning. It is also concluded that it is necessary to increase the size of the bellows from 1000 ml to 1200 ml to meet AMIB requirements so that the minute volume reaches up to 70 liters/minute. Finally, although the scientific community, to date, does not recommend the use of a single traditional equipment to ventilate more than one patient, with the new ventilator design that is the focus of this research it is concluded that this challenge has been overcome, as it does allow ventilate two differentiated lungs respecting the individuality of each patient and without risk of cross-contamination.