100 RESPIRA ventilators from GAPInnova delivered to the SEM to continue clinical trials with COVID-19 patients in other hospitals
Respresentatives of the Hospital Clínic, Barcelona, the Germans Trias i Pujol Research Institute and GPAINNOVA have delivered the first 100 RESPIRA emergency ventilator devices to the Operations and Logistics Centre set up by the Medical Emergency System (SEM). The device has passed the first phase of the clinical trial and this donation means it will be distributed to other hospitals in Catalonia, according to their needs, to expand the study.
The initiative, together with the other prototype ventilators developed, has been made possible thanks to the support received from a great number of private individuals, companies and entities from civil society, and of the Fundació Clínic per a la Recerca Biomèdica, which has supplied resources. It has also been able to count on the support of the Catalan Health Service, which has facilitated the incorporation of companies into the project and provided support to the research centres seeking for this type of solution.
The clinical trial has been carried out with patients in the Hospital Clínic, Barcelona, who have received ventilation support with positive results. Now the first phase of the clinical trial has been successfully completed, it can be expanded at other hospitals in the health system.
How does the emergency ventilator work?
The RESPIRA device automates the hand-held reanimation devices (BVM and AMBU), currently found in all health centres, and makes it possible to provide mechanized assisted breathing for the patient.
It is equipped to be able to monitor each patient's variables in real time, while permitting remote control to improve management in hospitals.
The device includes the electronics necessary for staff to remotely control variables such as air frequency, volume and pressure delivered to the patient, which are provided by SIEMENS and a a precision drive unit manufactured by SMC. A central control station allows staff to monitor up to 16 units simultaneously using the systems's own wifi.
On 31 March the first validation trials were completed at the Hospital Clínic, Barcelona with a simulator and on 1 April they were carried out in animals at the Centre for Comparative Medicina and Bioimage (CMCiB) at the Germans Trias i Pujol Research Institute. In parallel, as established by the regulations of the Spanish Agency of Medicines and Medical Devices (AEMPS), tests on electromagnetic compatability were carried out to ensure that the device does not cause interference with other medial equipment at healthcare facilities. After authorizaiton by the AEMPS, the clinical trial was set up with patients affected by COVID-19.
The Catalan company MAN is collaborating with industrialization and productiom, which is being carried out at the factory in Santa Perpetual de Mogoda.