Medschool, ANE, Research, Device Development

The COVID 19 pandemic ushered in a grim reality that hospitals all over the globe may not have enough ventilators to care for the onslaught of critically ill patients. The Department of Defense, Defense Health Agency responded to this global health crisis with the “Vulcan Innovator Challenge” to develop easily manufactured, low cost ventilators. Following selection and prototype development, a team lead by Drs. Hudson, Bedocs, and Lee aimed to evaluate the frontrunning limited performance ventilators in an in vivo system, including a novel clinically relevant model of acute respiratory distress syndrome (ARDS). After revealing and correcting many safety and reliability concerns, 4 of the 5 prototype ventilators were able to maintain adequate ventilation in healthy animals, achieve hypo- and hyperventilation, and maintain acceptable respiratory parameters in animals with severe ARDS.

In addition to the limited function prototype ventilators, we also demonstrated the feasibility of noninvasive home and sleep laboratory bilevel PAP ST devices to provide invasive ventilation with two different single limb passive breathing circuits with an intentional leak. These devices were able to maintain both adequate ventilation and oxygenation.

To further optimize the usefulness of BiPAP machines, the Fixed Resistance Connector Valve (FRCV) developed by anesthesiologists at Mt. Sinai to convert traditional circle system anesthesia circuits into bilevel circuits was evaluated by the ANE team. The FRCV operationalizes equipment (anesthesia circuits) that traditionally could not be used and optimizes oxygen usage without significant rebreathing.

The next objective of this focus area is to evaluate and compare the functionality of various small-form battlefield ventilators. The goal is to determine whether the ventilators can provide sufficient minute ventilation and oxygen delivery to sustain acceptable oxygenation and gas exchange for several hours.

• Lead Researchers: Arlene Hudson, MD, MA, FASA (arlene.hudson@usuhs.edu); Peter Bedocs, MD, PhD (peter.bedocs.ctr@usuhs.edu); Jong Lee, MD (jong.lee@usuhs.edu)

• Outcomes:

  • Foster BE, Diaz-Abad M, Hudson AJ, Bedocs P, Doll DM, Lopez SA, Mares J, Hutzler J, Robertson BD. Invasive mechanical ventilation using a bilevel PAP ST device in a healthy swine model. Sleep Breath. 2020 Dec;24(4):1645-1652. doi: 10.1007/s11325-020-02141-x. Epub 2020 Aug 6. PMID: 32761535; PMCID: PMC7406961.

  • Validating The Safety Profile Of An Fda Emergency Use Authorization Approved Ventilator Accessory Called The "fixed Resistance Connector Valve" To Convert An Anesthesia Circuit Into A Bipap Circuit. Brian Mayrsohn M.D., M.S., Nigel Wilkinson-Maitland M.D., Feroz Osmani M.D. , Shan Zhao M.D., Daniel Katz M.D., Nathaniel Kapaldo D.V.M., M.P.H., Jong Lee M.D., Arlene Hudson M.D., Peter Bedocs M.D., Ph.D. American Society of Anesthesiologists Annual Meeting 2021.

  • Evaluation of Prototype Ventilator Designs to Fill the Impending Gap in Response to COVID-19. Peter Bedocs, Jong Lee, John Mares, Justin Hutzler, Huckelberry Finne, David Burmeister, Arlene Hudson. American Society of Anesthesiologists Annual Meeting 2020.

The treatment of mass casualties, whether on the battlefield or at home has historically been predicated on the availability of well-equipped specially trained medical staff and the ability to rapidly evacuate patients. However, with global events like the COVID-19 pandemic and expected challenges in future near-peer multi-domain conflicts, emergency response planners must now prepare for “prolonged field care” where the sick and injured may be required to remain at the point of injury many days. This research led by Dr. Bedocs aims to advance medical device interoperability and remote control to address pandemic conditions and a growing need to support military prolonged emergency field care. The remote control of bedside medical devices to be used in this project include Thornhill Medical’s portable integrated life support system, which offers a computer-controlled portable ventilator with oxygen generation capability, vital signs monitoring and suction, and the NeuroWave Systems AccuPump 2-channel infusion system. The system will be tested and evaluated at USU and Massachusetts General Hospital.

• Lead Researcher: Peter Bedocs, MD, PhD (peter.bedocs.ctr@usuhs.edu)