The ACUTE-19 device was the first prototype of a bi-level turbine ventilator for the monitored ventilation of patients infected with COVID-19. An emergency respirator designed remotely in record time and during the confinement, by doctors from different specialties, engineers, 3D design technicians and veterinarians from the CEU Cardenal Herrera University (CEU UCH), in a project coordinated by doctor José Miguel Alonso, from the Department of Anaesthesiology, Resuscitation and Treatment of the La Fe university hospital of Valencia. Its design, published in open code, makes it accessible to be manufactured anywhere in the world where hospital pressure creates a need for more respirators to treat the acute respiratory distress syndrome that patients with COVID-19 suffer. Its pre-clinical validation method was published recently in the most relevant Spanish journal of its field, published by the Spanish Society of Anaesthesiology, Resuscitation and Pain Therapeutics.
In the article, “Validación preclínica de un respirador de turbina para la ventilación invasiva: el respirador ACUTE-19”, published in the latest edition of the Revista Española de Anestesiología y Reanimación, the researchers explain the three stages of the method designed to rapidly assess the device, in light of the urgency derived from hospital saturation. This validation consisted of assessing the administration of a certain volume in 11 simulated lung models with various resistances and compliances. After this fist step, the behaviour of the ACUTE-19 turbine ventilator was compared to a commercial ventilator, adapted to the recommendations of the UK’s Medicines and Healthcare products Regulatory Agency for fast-manufactured ventilators. And the third stage, decisive before using the device in humans, was to perform in vivo tests in a sheep animal model, carried out at the Veterinarian Clinical Hospital of the CEU UCH, under the guidance of professors José Ignacio Redondo and Jaime Viscasillas, together with Álvaro Gutiérrez, who is currently at the University of Hannover.
Optimal oxygenation and ventilation
According to Anaesthesiology professor at the CEU UCH José Ignacio Redondo, “ACUTE-19 achieved optimal oxygenation and ventilation before and after inducing acute respiratory distress syndrome in an animal model. The device showed a reliable performance and behaved accurately in the simulated and animal models in all tested scenarios, with a performance comparable to that of a commercial device. Thus, its design can act as the basis for the development of a future affordable commercial ventilator, which could be manufactured if there was a lack of ventilation devices due to hospital saturation, an increase of people in ICUs or patients who require ventilatory support, anywhere in the world.”
Furthermore, turbine respirators such as ACUTE-19 do not require compressed air and can generate the maximum respiratory flow required for invasive or non-invasive ventilation. This makes them especially useful to treat patients who require any type of ventilatory support, as they only use a low-pressure source of oxygen. This is why it could be a good option in situations of local outbreaks of the pandemic and in countries with limited resources in their healthcare systems, as the project is based on open access so it can be reproduced freely and universally.
The study published in the Revista Española de Anestesiología y Reanimación represents the first preclinical study that assesses a new and affordable turbine ventilator, designed specifically to be used during the SARS-CoV-2 pandemic. Alongside doctors José Miguel Alonso, from La Fe hospital, and CEU UCH professors José Ignacio Redondo, Jaime Viscasillas and researcher Álvaro Gutiérrez, fellow co-authors of the study are members of the team that created the ACUTE-19 prototype, including doctors Óscar Díaz and María Pilar Argente, also from La Fe; Miguel Casañ and Guido Mazzinari, from the Anaesthesiology, Resuscitation and Treatment of Pain at the General University Hospital of Castellón; and José Ramírez Paz, from the Department of Electric Engineering of the University of Córdoba; and Pedro Alonso Pérez, from TEcnikoa 3d Filaments S.L.; among other researchers.
Collaborating entities were Tecnikoa 3D Filaments, Darimo Carbon Fiber, AIC Medical, the VMNNI CR Valencia Non-Invasive Mechanical Ventilation and Respiratory Care Group, Oximesa Nippon Gases, the University of Córdoba and the CEU Cardenal Herrera University. This project is also partially funded by a subsidy connected to COVID-19 from the Valencian Agency for Innovation (DOGV 2020/3509).
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