The device, which was designed in Málaga, was given the green light by Health and Families after it was tested in a patient with COVID-19 hospitalized in the ICU of the Virgen de las Nieves Hospital of Granada.
The Virgen de las Nieves Hospital was the site of the second trial in a human subject of the ‘Andalucía Respira’ respirator, which was designed in Málaga. Specifically, the prototype of this device was tested in a patient with COVID-19 in the ICU of this hospital, which is part of the Andalusian public health system. The results of the trial were indicators of success that validate this technology, which was designed by researchers at the Biomedical Research Institute of Málaga (IBIMA, for its initials in Spanish), engineering professors at the University of Málaga, and physicians at the Regional University Hospital of Málaga and the Virgen de la Victoria University Hospital of Málaga, and perfected by an advanced technology company headquartered in the Andalusia Technology Park (PTA, for its initials in Spanish).
The respirator, which was already successfully tested in a patient hospitalized in the ICU of the Antequera Hospital (Málaga), completed an initial test in an artificial lung a few days ago as well as in an animal model. On Thursday, April 2, it was tested in this patient, who has acute respiratory failure and requires mechanical ventilation. The patient, diagnosed with COVID-19, is in the Intensive Care Unit of the Virgen de las Nieves Hospital of Granada.
As in the first trial, the patient was accompanied by a specialist physician over the course of 4 hours in order to evaluate possible variations in his vital signs so that he would be able to be switched to conventional respirator at any moment through a simple maneuver. Once again, this trial, which is fundamental for moving forward with approval of the respirator, was made possible thanks to the consent of the patient’s family members.
General characteristics of the respirator
This device is able to manufactured in approximately two hours and does not use any moving parts, thus reducing the risk of mechanical failure and materials fatigue. The system’s electric controller is based on commercial automatons designed for continuous use with very low failure risk. This means that it allows for the easy modification of several respiratory parameters such as respiratory rate, pressure, and the inspiratory-expiratory ratio, thus offering a real alternative to the currently-approved respirators in intensive care units for patients in severe condition with COVID-19 symptoms.
The prototype has been certified by a top-level external laboratory and has been validated by the Spanish Agency of Medicines and Medical Devices (AEMPS, for its initials in Spanish) after all the required documentation was submitted. In order to verify its proper functioning, this governmental organization required two clinical trials to be performed in patients. The first trial took place in Antequera and the second in Granada. Both trials were successful in regard to ventilation and oxygenation of the patient and, as a secondary variable, in regard to the damage associated with mechanical ventilation itself.
Two additional tests of a more technical nature, which will be performed by an external certifying laboratory, must still be completed. One test is on electromagnetism, that’s to say that it does not interfere with the operation of the other equipment around it, and the other is a test of the device’s autonomy with UPS, which has to last for 48 hours.
Once the results are available, the AEMPS must rule on the suitability of the prototype so that it may be manufactured and begin to be supplied to the healthcare centers that need it, given this time of extraordinary need for respirators in some ICUs. This will help guarantee access for all patients who need them.
Multidisciplinary Team of Professionals
This prototype was invented by a team of professionals from different fields who were moved by a desire to improve patients’ current conditions and collaborate with healthcare professionals who safeguard the health of the public. The team includes Ignacio Díaz de Tuesta, cardiovascular surgeon, and Miguel Ángel Prieto, intensive care physician—both from the Regional University Hospital of Málaga—as well as José Luis Guerrero Orriach, anesthesiologist from the Virgen de la Victoria University Hospital of Málaga. The medical team was advised by Gonzalo Varela Simó, thoracic surgeon and scientific adviser at the University Hospital of Salamanca.
Víctor F. Muñoz and Carlos Pérez del Pulgar, engineering professors at the University of Málaga who were responsible for programming the automation, participated in the transfer of the idea’s original design to healthcare engineering, taking into account the parameters indicated by the healthcare professionals. Likewise, UMA Professor María Victoria de la Torre; Emilio Curiel, intensive care physician at the Regional University Hospital of Málaga; and Ricardo González-Carrascosa, UMA Veterinarian, also participated, along with numerous companies who contributed by voluntarily providing material in order to produce the prototype, including Veolia, Air Liquide, CATS, and Dekra.
IBIMA Scientific Director Francisco J. Tinahones along with Isabel Guerrero and María Mengual, from the Innovation Unit of the Málaga research institute; Juan Aranda, its director of management; and José Miguel Guzmán, its managing director, also participated in the development of this prototype.