Challenges for the development of alternative low-cost ventilators during COVID-19 pandemic in Brazil

Abstract

The COVID-19 pandemic has brought concerns to managers, healthcare professionals, and the general population related to the potential mechanical ventilators’ shortage for severely ill patients. In Brazil, there are several initiatives aimed at producing alternative ventilators to cover this gap. To assist the teams that work in these initiatives, we provide a discussion of some basic concepts on physiology and respiratory mechanics, commonly used mechanical ventilation terms, the differences between triggering and cycling, the basic ventilation modes and other relevant aspects, such as mechanisms of ventilator-induced lung injury, respiratory drive, airway heating and humidification, cross-contamination risks, and aerosol dissemination. After the prototype development phase, preclinical bench-tests and animal model trials are needed to determine the safety and performance of the ventilator, following the minimum technical requirements. Next, it is mandatory going through the regulatory procedures as required by the Brazilian Health Regulatory Agency ( Agência Nacional de Vigilância Sanitária - ANVISA). The manufacturing company should be appropriately registered by ANVISA, which also must be notified about the conduction of clinical trials, following the research protocol approval by the Research Ethics Committee. The registration requisition of the ventilator with ANVISA should include a dossier containing the information described in this paper, which is not intended to cover all related matters but to provide guidance on the required procedures.

The oxygenation module: the missing link in using sleep apnea devices to treat COVID-19 pneumonia at home

“…Mortality appeared to have decreased significantly in patients with diabetes (19% vs 43%) and arterial hypertension (8 vs 26%). The rapid progression of the disease correlated with the radiological scene of pneumonia when the groundglass phase (days 1-6) transforms into the reticulation phase (7)(8)(9)(10)(11)(12)(13)(14). Early treatment with CPAP was also described in other studies [6,7] as well as in editorial letters [8].…”

“…Industrial enterprises and scientists also tried to succeed in development of low-cost ventilators [11][12][13][14][15]. Despite the fact that Garmendia et al [16] designed and clinically tested even much cheaper CPAP machines proposing 70-80 EUR instead of 600 EUR, the next study shows that early CPAP intervention could result in a potentially viable treatment option for patients only during the first days of hospitalisation [17].…”

“…For example, researchers correlate high levels of FiO 2 (0.4-0.8) or high oxygen use (> 10 L/min) before using NIV with higher mortality (OR 1.59) [13,14]. In turn, for those who used non-invasive ventilation with lower FiO 2 support, mortality decreased [15].…”

The Oxygenation Module - The Missing Link in Using Sleep Apnea Devices to Treat COVID-19 Pneumonia at Home

“…Industrial enterprises and scientists also tried to succeed in development of low-cost ventilators [11][12][13][14][15]. Despite the fact that Garmendia et al [16] designed and clinically tested even much cheaper CPAP machines proposing 70-80 EUR instead of 600 EUR, the next study shows that early CPAP intervention could result in a potentially viable treatment option for patients only during the rst days of hospitalisation [17].…”

Continuous mandatory ventilation with pressure-control: a comparison of airway-pressure waveform patterns.

“…The statistical analysis of E% was not conducted due to the fact that this parameter was derived from AE. According to the ANVISA, the manufacturers have to present clinical and laboratory trials (SUZUMURA et al, 2020 This study has begun due to the unexpected findings in CMV-PC pressure signals from commercial and prototype lung ventilators that were recorded for maintenance and assessment at the node IPT-POLI. These findings highlighted gaps in the standard that allow different waveform shapes to comply with standard requirements.…”