The last phase of the development of prototype Acute-19 has been successfully completed at the clinical hospital of CEU Cardenal Herrera hospital in Valencia, with results that have surpassed expectations.
The first prototype of a bi-level turbine ventilator for pressure-monitored ventilation in patients affected by Covid-19, Acute-19, developed by Spanish researchers, has just successfully surpassed the validation phase in an animal model at the CEU Cardenal Herrera University of Valencia. This last step is essential for its use in humans, meaning it will be used very soon in patients who require mechanical ventilation due to respiratory complications from the Covid-19 disease.
The validation in an animal model was successfully conducted at the Hospital Clínico Veterinario of the UCH CEU, by the team comprised by professor and head of the Anaesthesiology department, José Ignacio Redondo, professor and head of the Large Animals department Jaime Viscasillas, and Álvaro Gutiérrez, member of this department, together with anaesthesiologists José Miguel Aonso, from the La Fe hospital and project leader, and Miguel Casañ, from the Hospital General of Castellón, and with engineer Damià Rizo, from Darimo Carbon SL, one of the creators of the ventilator.
After designing and assembling the prototype and testing it in different respiratory simulation models, bi-level turbine respirator for invasive ventilation Acute-19 has shown its efficacy and reliability for the ventilation of a healthy animal model and an animal model with an induced respiratory distress pathology, in tests conducted recently at the CEU UCH. As professor José Ignacio Redondo explains, “during the testing on the animal model of prototype Acute-19, we have assessed three aspects: the respiratory mechanism, the gas exchange and haemodynamic parameters. The validation has been conducted with anaesthetised sheep, monitoring the spirometry and all vital signs in a non-invasive way. In the animal model test, the data from the mechanical ventilation has been analysed by way of a flow sensor, as well as with gas, haemodynamic and oxygenation data, showing the efficacy and reliability of the Acute-19 prototype.”
The professor stresses that “the results during animal testing have overcome the team’s expectations: the prototype has shown reliability not just during mechanical ventilation, but also in the transition phase to spontaneous ventilation, or weaning phase. Furthermore, we also validated the Acute-19 model in CPAP mode, in other words, as an additional ventilatory platform during the recovery phase of patients, where they need help to breathe spontaneously, meaning it can also be used outside ICUs to provide ventilatory support for non-intubated patients.”
First turbine ventilator, validated at the CEU UCH
Acute-19 is the only turbine ventilator of its characteristics that has been developed and validated in Spain in an animal model during the confinement period decreed on 14 March. There are several teams in Spain, both from companies as well as research centres, that have developed models of bag mask ventilators, or mechanical manual balloons, or with a compressed gas compressor, in order to send oxygen into the patient. But the operation of turbine ventilators, such as Acute-19, is better in terms of the stability of gas flow than those that work with other motor systems. Unlike other ventilators being developed, Acute-19 is based on a turbine that has a set of sensors and actuators to accurately regulate the air output pressure that is sent to the patient, making it possible to adjust inspiratory and expiratory pressure parameters, respiratory frequency and inspiration-expiration relation.
In addition to these differential features, there is now the fact that very few devices have thus far surpassed the animal model testing of their prototypes. “For these reasons, with this validation at the CEU UCH we have taken a very important step forward for the Acute-19 model to start being manufactured in order to ease the current need for suitable ventilators for Covid-19 patients,” highlights professor José Ignacio Redondo.
Next clinical phase
The Acute-19 project team now starts the clinical phase with a prior observational study in patients with no respiratory pathology, at the Hospital Universitario La Fe of Valencia, headed by anaesthesiologist José Miguel Alonso, project director, with the collaboration of specialists Guido Mazzinari, Óscar Díaz, Jorge Puchol and María Pilar Argente. Alonso also stresses the ease of the design and efficiency of ventilators based on turbines, the components of which can be obtained easily: “These are important advantages regarding its manufacturing and development, which is why we hope to begin their manufacturing soon and make them available to anyone who needs to produce them anywhere in the world by way of an open source system on the project website, http://acute19.com/.”
This design of the Acute-19 prototype, which has now been tested, has been developed by a multidisciplinary team comprised by José Ramírez Paz, from the Universidad de Córdoba; Damià Rizo Morant, from Darimo Carbon S.L.; Pedro Alonso Pérez, from Tecnikoa 3d Filaments S.L.; and José Miguel Alons Íñigo, head of the VMNI CR Group of Experts in Non-Invasive Therapies of Valencia.