New ventilator device developed by the Hospital Clínic, Germans Trias i Pujol and Barcelona University with Protofy.xyz gets the go ahead from the AEMPS for clinical trials

The ventilation device OxyGEN has received the authorization of the Spanish Agency of Medicines and Medical Devices (AEMPS) to carry out clinical trials. It has been developed by Protofy.xyz with scientific and financial support from the health professionals of the Hospital Clínic Barcelona (UB), the Germans Trias I Pujol hospital at Can Ruti and the Faculty of Medicine and Health Sciences at the University of Barcelona.

This trial will take place at the Hospital Clínic and Can Ruti and will allow the prototype device to be tested more thoroughly in eight patients. Last week tests were carried out in two patients at the Germans Trias i Pujol Hospital. If the tests with more patients are successful the device will provide a response to the lack of conventional ventilators caused by the COVID-19 pandemic and their use will be extended to more Catalan and Spanish hospitals. Seat will produce the devices in Martorell.

This initiative has been possible thanks to the support of a large number of private individuals, companies and organizations from civil society. They have also had the support of the Catalan Health Service, which has facilited the incorporation of the companies and has supported the centres seeking this type of solution.

A ventilation device to deal with COVID-19

The objective of OxyGEN is to provide help with ventilation for patients with severe respiratory problems, such as those with COVID-19, when conventional ventilators are not available. It is designed for temporary use during the emergency.

It is an emergency device that allows the automization of manual rescusitators (AMBU type), in an autonomous and mechanized way, so they can be used to maintain respiration. It also allows respiratory frequency and volume to be controlled constantly, together with the inspiration/expiration ratio providing support to the patient that they would otherwise not have.

It is a simplified modular design so that it is easy to set up, while guaranteeing that it functions correctly in emergency situations. Protofy.xyz has provided the engineering plans for OxyGEN to the community so it can be manufactured anywhere in the world. There are many projects in different countries using local developments, including in Israel, India, USA, Argentina and Nicaragua.

The device has passed validation tests with simulators in the Faculty of Medicine and Health Science of the UB on the Hospital Clínic Campus and with animal models at the Centre for Comparative Medicine and Bioimage (CMCiB) at the Germans Trias I Pujol Research Institute (IGTP). It has also passed controlled tests with patients, carried out with the necessary authorizations from the corresponding ethical committees, at the Germans Trias i Pujol Hospital.

The team supervising the tests is made up of Dr Josep M. Nicholás, specialist in intensive care medicine and Lecturer at the UB and Dr Ramón Farré, Professor of Physiology at the UB and leader of the group in Respiratory Biophysics and Engineering at the IDIBAPs and Dr Manel Puig, of the Germans Trias i Pujol Research Institute (IGTP). Dr Martí Pons, specialist from the Intensive Care Unit of Sant Joan de Deu Hospital, has also participated

Dr. Josep M. Nicolàs explains, "from the Hospital Clínic and the University of Barcelona we are bringing our knowledge of methodology for the creation and calibration of devices."

Dr Manel Puig, underlines that fact that, "It is an enormous  and coordinated effort to accelerate the processes while maintaining all guarantees and pass all the tests in order to reach patients as quickly as possible. We are putting all the expertise and experience of multiple agents within the Catalan health research system at the service of the emergency services in record time."

From Innnovation Management team at the  Germans Trias i Pujol Hospital Dr David Priego,  Dr Marc Fabra, Dr Hipòlit Pérez and Dr Oriol Estrada have worked since the first instance on the development, improvement and validation of the ventilators. Dr Estrada, Director of Innovation at the hospital, confirms that "the OxyGEN project is a coordinated effort by many professionals and institutions, who have managed to refine the idea and develop a reliable model that responds to the emergency situation in less than two weeks. Engineers, doctors and researchers have together brought about a crucial tool, which will be measured in hundreds of lives saved."

For his part, Dr David Priego, Clincial Expert for Innovation at the Germans Trias i Pujol Hospital considers that, "We have managed to develop a homologised and approved device, but we must not lose sight of the fact that it is to provide an answer to the current situation and will help us save many lives."

"Getting to this point has been made possible thanks to the efforts of all the players implicated; companies, hospitals, research centres, university and administration and in the final phase of development and industrial scaling of the prototype the donations received from private individuals, companies and civil society have been fundamental," adds Dr. Josep M. Campistol, Director General of the Hospital Clínic, Barcelona.

"It is thanks to this strategy of collaboration, that has connected people, hospitals and companies, that the project has been able to advance at a frenetic pace during the last two weeks in order to complete the complex phases of validation required in record time to be ready for the clinical trial," states Ignasi Plaza and Lluís Rovira, two of the co-founders of Protofy.xyz.