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Preclinical validation of occupational and environmental safety of an isolation system for noninvasive ventilation in COVID-19 and other aerosol-transmitted infections.

Claudio Almeida QuadrosMaria Carolina Bezerra Di Medeiros LealCarlos de Almeida Baptista-SobrinhoCarolina Kymie Vasques NonakaBruno Solano de Freitas SouzaJuliana Cristina Milan-MattosAparecida Maria CataiValéria Amorim Pires Di LorenzoAntonio Gilberto Ferreira
Published in: Expert review of medical devices (2020)
Background: The current SARS-CoV-2 pandemic has provoked the collapse of some health systems due to insufficient intensive care unit capacity. The use of continuous positive airway pressure (CPAP) and high-flow nasal oxygen (HFNO) therapies has been limited in consideration of the risk of occupational infection in health-care professionals. Aims: In preclinical experimental simulations, evaluate occupational and environmental safety of the newly developed isolation system for aerosol-transmitted infections (ISATI). Method: Simulations were conducted to test ISATI's capability to isolate aerosolized molecular (caffeine), and biological (SARS-CoV-2 synthetic RNA) markers. Caffeine deposition was analyzed on nitrocellulose sensor discs by proton nuclear magnetic resonance spectroscopy. Synthetic SARS-CoV-2 detection was performed by reverse transcription-polymerase chain reaction. Results: ISATI demonstrated efficacy in isolating molecular and biological markers within the enclosed environment in simulated conditions of CPAP, HFNO and mechanical ventilation therapy. Neither the molecular marker nor substantial amounts of synthetic SARS-CoV-2 RNA were detected in the surrounding environment, outside ISATI, indicating appropriate occupational safety for health-care professionals. Conclusion: Aerosolized markers were successfully contained within ISATI in all experimental simulations, offering occupational and environmental protection against the dissemination of aerosolized microparticles under CPAP or HFNO therapy conditions, which are indicated for patients with acute respiratory infections.
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