The Air Force Research Laboratory and the University of Cincinnati have partnered to test an experimental closed-loop medical technology designed to help clinicians manage oxygen requirements of patients undergoing mechanical ventilation.
AFRL's 711th Human Performance Wing supports the clinical trial as part of a cooperative agreement with UC and the partnership will use data from the study to help advance ventilators used to treat hospital COVID-19 patients, the laboratory said Wednesday.
Dario Rodriquez, a 711 HPW senior research health science officer and director of clinical research within UC’s Division of Trauma/Critical Care, said a closed-loop device has the potential to cut risk of exposure among medical personnel and reduce the time they spend adjusting breathing machine settings.
The system uses an algorithm to automatically oxygen levels based on the acceptable saturation range a health care provider has set for the patient.
As the host center, UC also teamed up with multiple hospitals to test the technology with patients who consented to participate in the trial, which has reached an enrollment rate of 88 percent to date. Researchers have collected data from 184 particpants, AFRL noted.
The 711 HPW-UC team initially tested an Impact Instrumentation-built ventilator in 2006.
Rodriguez said the Food and Drug Administration required the new trial after Zoll Medical acquired Impact and updated the device. Researchers aim to enroll enough participants to gather safety and efficacy data the company will need to submit to the FDA.
The agency will then review the findings to determine whether clinical evidence is sufficient to approve the technology for market availability.