Health and Families tested the device in a patient with COVID-19 who is hospitalized in the Antequera Hospital ICU.
This afternoon, the first trial in humans of the ‘Andalucía Respira’ respirator, which was designed in Andalusia, was successfully completed at the Antequera Hospital. 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 in regard to ventilation and oxygenation of the patient and, as a secondary variable, in regard to the damage associated with mechanical ventilation itself.
The Ministry of Health and Families of the Regional Government of Andalusia, in collaboration with the University of Málaga, has designed the prototype of this new respirator to reinforce medical care as a consequence of the COVID-19 disease. This device was created by a multidisciplinary team comprising healthcare professionals from the Regional University Hospital of Málaga and the Virgen de la Victoria University Hospital of Málaga, scientists from the Biomedical Research Institute of Málaga (IBIMA, for its initials in Spanish), and engineers from the University of Málaga. Its development responds to the need for more respirators in the intensive care units (ICUs) of hospitals that may be overwhelmed caring for patients with respiratory pathology caused by the novel coronavirus.
In order to put the respirator into use, the Spanish Agency of Medicines and Medical Devices (AEMPS, for its initials in Spanish), will require two clinical trials to be performed in patients to verify its proper functioning. The first of them has been conducted today at the Antequera Hospital (Málaga) and was a success.
The respirator, which was tested in an artificial lung a few days ago and also in an animal model, has been tested in a patient with acute respiratory failure who requires mechanical ventilation. The patient is in the Intensive Care Unit of the Antequera Hospital and has been diagnosed with COVID-19. 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. This trial, which allows for approval of the respirator to continue moving forward, was made possible thanks to the consent of the patient’s family members.
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. Numerous companies 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 at the Málaga research institute, and José Miguel Guzmán, its managing director, also participated in the development of this prototype.