The clinical trial of a local ventilator will start in November, according to the Department of Science and Technology (DOST).
Called the OstreaVent II, the ventilator is an upgrade of its predecessor, the OstreaVent I which is for infant use only. The OstreaVent II can be used by both infant and adult patients who need assistance to breathe.
Designed in the context of the pandemic, it has bacterial and viral filters.
OstreaVent II also preempts the potential supply gaps if and when the number of new coronavirus disease 2019 patients in intensive care needing ventilators increase.
A prototype of the OstreaVent II was completed in June 2020. The University of the Philippines (UP) Manila Research Ethics Board approved its Safety Trial Protocol the following month.
In March this year, the OstreaVent II’s Medical Device Inspection Certificate was issued by the Med-Equip while the Food and Drug Authority of the Department of Health granted the Certificate of Medical Device Listing to signify OstreaVent II may proceed with the clinical trial.
In April, the Breath of Life Foundation formed the team that will implement the one-month clinical trial that will involve 10 non-COVID patients based on the Safety Trial Protocol.
The team will be headed by Dr. Manuel Jorge who leads the Adult Pulmonology Fellows at UP Manila’s Philippine General Hospital (PGH).
After the clinical trial, five units of the OstreaVent II will be produced: four will be used for field testing and one will be used for further design improvements.
If all criteria are met, the licensing and production of a local ventilator may begin by November, DOST Secretary Fortunato T. Dela Pena said.
Research and development for the OstreaVent I and II was supported by DOST’s Philippine Council for Health Research and Development (PCHRD). Taking the lead in the fabrication of the OstreaVent II is the DOST’s Metals Industry Research and Development Center in partnership with the Breath of Life Foundation.
The OstreaVent II is one of the science interventions to address the COVID-19 pandemic, Dela Pena said.
The PCHRD, for one, is overseeing the ongoing clinical trials of virgin coconut oil (VCO) and melatonin as potential treatment and adjunctive therapy for COVID-19 patients.
These projects received funding support from PCHRD and are being implemented by partner research institutions and various hospitals. – Paul Icamina
