Adult Ventilator Developed by DOST-MIRDC Set to Undergo Clinical Trial
By: Zalda R. Gayahan
The clinical trial for the OstreaVent II is the next step for this locally designed and developed ventilator for adults. It will be done at the Philippine General Hospital. At the moment, the team who will conduct the clinical trial is just waiting for the appropriate time when the PGH facility and medical workers are not too overwhelmed with Covid-19 cases.
Taking the lead in this research and development is the DOST-Metals Industry Research and Development Center in partnership with the Breath of Life Foundation, Inc.
OstreaVent II used the technology of its predecessor, the OstreaVent I, which is for infant use only. The project team embarked in R&D to design the OstreaVent II so that it will have the following features: it can be for both infant and adult use; it is both pressure- and volume controlled; it has a feature to measure tidal volume; and it has bacterial and viral filters.
After the completion of the OstreaVent II prototype in June 2020, it was subjected to a medical Device Inspection by the MedEquip. The University of the Philippines Manila Research Ethics Board (UPMREB) approved its Safety Trial Protocol in July 2020. In March this year, the OstreaVent II’s Medical Device Inspection Certificate was issued by the MedEquip and the Food and Drug Authority (FDA) granted the Certificate of Medical Device Listing to signify that the OstreaVent II may proceed with the clinical trial.
In April 2021, the Breath of Life Foundation formed the team that will implement the clinical trial for one month which, based on the Safety Trial Protocol, will involve 10 non-Covidpatients. The team will be headed by Dr. Manuel Jorge who heads the team of Adult Pulmonology Fellows at the UP-Philippine General Hospital.
After the clinical trial, five units of the OstreaVent II will be produced: four will be used for field testing, one will be used for further design improvements. If all activities will proceed as planned, licensing and production may begin by November this year.