In France, the number of ventilators already in service turned out to be sufficient to treat Covid-19 cases during the initial peak of the epidemic. However, in some cases, hospital staff did have to use emergency and transport ventilators, which do not have the continuous pressure and flow monitoring required to treat Covid-19 patients optimally. Physicians working in intensive care units felt that these types of ventilators could be upgraded to more effectively treat Covid-19 patients. List, a CEA Tech institute and member of the Carnot Network, partnered with the CEA’s Frédéric Joliot Medical Unit to develop the CLEAR-M monitoring system. On 10 April two tests were completed on a test lung in a hospital setting under the supervision of Dr. Frédéric Minko, who heads the Nord Essonne Hospitals Emergency Department in Orsay, France. The system was then tested at the Raymond Poincaré Hospital in Garches in the intensive care unit, which is headed by Professor Djillali Annane. CLEAR-M was compared with the measurements taken by a reference ventilator and performed well.
On 16 April, CLEAR-M was tested in the ventilator weaning ward at the Raymond Poincaré Hospital in Garches by Professors Hélène Prigent and Frédéric Lofaso on Covid-19 patients in recovery but still on ventilators. CLEAR-M was also implemented at the Nord Essonne Hospitals Emergency Department in Orsay.
In order to ensure free access to the system, the CEA patented it and made the license available free of charge for anyone wishing to manufacture it. BA-Healthcare reached an agreement with the CEA and will be the first manufacturer to produce several thousand units of the CLEAR-M system.
To meet the needs of countries without enough ventilators, the researchers also developed a new emergency ventilator concept, CLEAR-R. The design combines a robotically-controlled manual resuscitation bag and the CLEAR-M monitoring system.
The proof-of-concept prototype was completed in late March. The prototype and hospital testing protocol were then developed in early April. Healthcare experts validated the prototype and its respiratory assistance capabilities, and List researchers then did their own tests on a simulator and in vivo at the National Veterinary School in Maisons-Alfort. At the same time, manufacturing and assembly instructions were written.
And, to make the new system widely and rapidly available, a test run of five ventilators was manufactured and made available to healthcare facilities and device manufacturers interested in getting the system certified, doing clinical trials, and launching volume manufacturing.
The CLEAR project was made possible by dozens of people at the CEA (through List and the Frédéric Joliot Medical Unit) in partnership with intensive care physicians at the Nord Essonne Hospitals in Orsay and at the Raymond Poincaré Hospital in Garches, as well as at hospitals in Marseille and Corbeil-Essonne, and, finally, with researchers at Inserm.