June 26, 2020

“A breather for Chile”: Progress with clinical trials of mechanical ventilators made in Chile

“A breather for Chile”: Progress with clinical trials of mechanical ventilators made in Chile
The prototype designed by Asmar and Universidad de Concepción is the first to be tested on patients at Universidad de Chile’s Clinical Hospital. The “Un Respiro para Chile” (a breather for Chile) platform gained technical consensus to guarantee the safety and functionality of this equipment.

The “Un Respiro para Chile” initiative - which brings together the Science, Technology, Knowledge and Innovation Ministry, SOFOFA Hub, the Economy Ministry, the IDB and the SiEmpre fund - is moving forward with clinical trials of one of the five prototypes chosen in a process intended to facilitate the technical and clinical validation and scaling up of emergency ventilators designed and made in Chile.

The design by Universidad de Concepción and state-owned shipbuilding company Asmar has gone through technical testing at Universidad de Valparaíso and pre-clinical trials on animals at Universidad de Chile’s Clinical Hospital and is now in the final phase of testing on patients under the supervision of Universidad de Chile’s Clinical Hospital to determine whether these ventilators are safe and effective in addressing COVID19.

Science Minister Andrés Couve highlighted that “this process has been possible thanks to a rigorous validation protocol in which technical institutions, universities and highly qualified clinical staff have taken part. The objective is to test the safety and effectiveness of this equipment in complying with the requirements and the ease of using it in difficult conditions such as those presented by this pandemic. Once the prototypes have completed clinical trials, their use will be approved by the Health Ministry, to ensure that the safety aspects are covered with all the care needed in equipment that will be used to save lives.”

“At ASMAR we are very proud that, together with Universidad de Concepción and the support of Talcahuano’s Naval Hospital, we have taken part in developing a solution to provide ventilation assistance to critical Covid-19 patients during the health crisis affecting our country. As a strategic state-owned company in the defense sector, we put a team of engineers and technicians from our Talcahuano plant at the service of our country. Together with the University, they have succeeded in supplying Chile with the first mechanical ventilator built and validated in Chile,” explained ASMAR Director, Rear Admiral Luis Kohler.

The rector of the Universidad de Concepción, Carlos Saavedra Rubilar added, “it is vital for our country to strengthen these scientific-technological associations that will make it possible to build the foundations of a high-technology strategic healthcare industry that in this case has also come about through an agreement with the naval and defense industry. This is another example of the commitment by Universidad de Concepción and ASMAR to contributing together towards public policies that we are sure will help to save many lives. This is the result of hard work by many people and we have had the ongoing support of the Science and Technology Ministry.

Mr. Alan Garcia, Executive Director of the SOFOFA Hub, said "this process has opened up an unprecedented space for technological development in Chile, installing capacities that didn't exist prior to the pandemic.  Flexibility has been a key factor in this collaborative process, where we have managed to balance innovative capacity with the clinical and regulatory requirements. We have watched with enthusiasm and hope as various projects have progressed towards clinical trials with patients."

The “Un Respiro para Chile” (A breather for Chile) initiative was designed to support the process of validating and scaling up mechanical ventilators in Chile. Through this initiative, 35 prototypes were evaluated by a committee of experts (Consejo Multidisciplinario de Facilitación Crisis COVID-19), led by Eduardo Bitrán, in partnership with the the Chilean Society of Intensive Care Medicine (Sociedad Chilena de Medicina Intensiva, SOCHIMI) with the support of the Inter-American Development Bank and Socialab. There are now 5 prototypes undergoing the validation process. Currently, in addition to the equipment identified by “Un Respiro para Chile”, there are other prototypes that have progressed in this process.

The protocol designed by “Un Respiro para Chile", along with Chilean Society of Intensive Care Medicine (SOCHIMI) and two other medical societies (SACH and SOCHIMU), makes it possible to validate the efficacy and safety of emergency mechanical ventilators that did not previously exist in Chile. Different institutions have collaborated, such as: SOCHIMI, Universidad de Valparaíso’s CERTEMED laboratory, the ethics committee of the Pontificia Universidad Católica Clinical Hospital for the pre-clinical trials on animals and the ethics committee of Universidad de Chile for clinical trials on humans.

You can download the protocol by clicking here.