Dr. Jason Rose is submitting this administrative supplement in regards to the Notice of Special Interest: Availability of Administrative Supplements on Coronavirus Disease 2019 (COVID-19) under the PA-18-591 opportunity. The parent grant is Dr Rose?s K08 HL136857 Mentored Research Career Development Award. Dr. Rose is an Assistant Professor of Medicine and Bioengineering at the University of Pittsburgh. His parent grant focuses on the cardiovascular and mitochondrial effects of carbon monoxide (CO) poisoning and preclinical development of an antidote for CO poisoning. As a pulmonary and critical care physician, Dr Rose has been caring for patients with COVID-19 in the ICU. He helped lead preparations at the University of Pittsburgh Medical Center system to secure a healthy personal protective equipment and biotronic (e.g. ventilators) supply chain. The COVID-19 pandemic has progressed around the globe with over one million cases in the United States by May 2020. Up to 11.5% of US cases require intensive care unit (ICU) admission. In a scenario where a significant portion of the population (5%) develops COVID-19 in a short time period - through a ?second-wave? of infection or viral mutation increasing severity or infectivity - up to 1,000,000 could require mechanical ventilation in some models. US hospitals only owned 62,000 full-featured ventilators before COVID-19. Initiatives by the US federal government to invoke the Defense Production Act (DPA) will produce 130,000 new ventilators costing over $2.5 billion dollars. Further, while the DPA has activated the final assembly of ventilators, there is likely to be a shortage of key components (e.g. advanced semiconductors). Conversely, available low-cost and easy-to- fabricate emergency ventilators have limited function and cannot reliably ventilate COVID-19 patients with acute respiratory distress syndrome. These simple devices tax the limited critical care workforce with more bedside patient monitoring and additional training. Limiting unnecessary exposures to patients will protect workers. The central objective of this proposal is to develop a rapidly manufactured, full-capability adult ICU ventilator (?Robotic Ventilator? ? RoboVent) that can be controlled remotely to meet worst-case global ventilator demand at reasonable cost (<$800/unit).
Aim 1 : The device will be prototyped, using robotic principals, using easy-to- fabricate components. The RoboVent will provide closed-loop pressure assist-control (AC), volume AC and pressure-support modes of ventilation. Using novel sensing, control and actuation technology, developed by our group, the ventilator will offer full control over driving pressure (or tidal volume), positive end-expiratory pressure, respiratory rate, and inspiratory to expiratory ratio.
Aim 2 : The device will be validated for internal consistency and tested against commercially available adult ICU ventilator units using a test lung simulators. A pilot production batch will be validated similarly. These data will be submitted for FDA emergency use authorization. Following this work, the technology will be licensed to a new startup entity and up to 10,000 FDA-cleared remote ventilators per week can be deployed in conjunction with manufacturing partner Foxconn Technology Group.
The COVID-19 pandemic has already affected more than 4 million worldwide and worst-case scenario models ? a significant Fall season ?second-wave? or less likely viral mutation with increase in infectivity or severity ? predict up to 1,000,000 requiring mechanical ventilation. To prepare stockpiles adequately at reasonable cost and reduce healthcare worker exposures to the virus, a collaboration between the University of Pittsburgh Division of Pulmonary, Allergy and Critical Care Medicine and the Carnegie Mellon University Robotics Institute is developing a low-cost (<$800/unit), rapidly deployable and fully-functional adult ICU ventilator that can be controlled by a smartphone application ? the Robotic Ventilator (RoboVent). The current proposal will: 1) use robotic principals to prototype the RoboVent with closed-loop modern ventilation modes (e.g. volume assist- control, pressure support), 2) validate the performance of the ventilator and compare to currently used full adult- ICU ventilators using test lung simulation devices, and 3) use the results produced to enable an US FDA emergency use authorization submission for the RoboVent.
