Development of special flow controller for clinical trial ‘PROOF’
Funded by the European Commission as part of the research and innovation program Horizon 2020 and coordinated by the University Hospital Tübingen, Gloor Medical partnered up to develop an oxygen flow controller delivering up to 40 l of oxygen per minute. Further it had to meet the ability to perform in MR environment, ensuring specific flow values and covering eight different country standards.
Besides the university hospital Tübingen, eleven other clinical centres located in Germany, Spain, France, Belgium, Czech Republic, Finland, Sweden and Switzerland contribute to this study.
The aim of the study is to test if the consequences of severe ischaemic stroke can be reduced by rapidly applying high-dose oxygen therapy and therefore minimize or even prevent the killing of the cells at the centre of the stroke. The therapy will be applied to 500 patients. Especially to patients that are not near clinical facilities or have longer access times to emergency care, this could be of great benefit.
Prior to admission to the stroke unit, experience shows that patients are treated 30-60min with oxygen dose of 40 l/min, while the maximum treatment time with this level of oxygen is set to 4 hours. In case of proven positive effects on patients, this form of high-dose oxygen therapy certainly will be incorporated in standard care units in future.
The positive feedback of participating hospitals in terms of quality, accuracy and handling of our flow controller fills us with pride. All this, in addition to being able to contribute to research into the future treatment of patients with cardiovascular disorders and ischaemic strokes.
Since it was not easy to find a medical device that supplies the 40 l/min in a reliable manner while incorporating all other specifications, Ms. Monika Glauch (University hospital Tübingen) was very satisfied with the cooperation & the result. Gloor Medical took on the challenge with dedication and came up with the proposal within short time.
The results of the trial are expected to be published in the final report towards the end of 2022.