Michigan researchers and engineers have introduced a portable negative pressure tent that could have a very positive impact on hospitals overwhelmed by COVID-19 cases.
Michigan Medicine researchers designed the negative pressure tent, which recently received emergency use authorization from FDA. The portable device, called the AerosolVE Tent, works to contain and filter aerosols using a foldable canopy and motorized filtration system. It was developed by the Michigan Center for Integrative Research in Critical Care (MCIRCC) in collaboration with FlexSys, a Michigan-based mechanical systems engineering company. FlexSys has formed InspireRx, a Michigan Medicine spinoff company, to bring the product to the market.
“We have had requests for this product coming in from hospitals around the country,” said Sridhar Kota, PhD, CEO of InspireRx and an engineering professor at the University of Michigan. “We have partnered with an approved manufacturer with a scalable manufacturing capacity and are ready to begin distribution.”
Nate Haas, MD, assistant professor of emergency medicine at Michigan Medicine and one of the clinicians who led the development and testing, said the negative pressure tent helps patients by allowing more liberal use of proven therapies while protecting healthcare workers and other patients in the process.
"The device can turn any hospital bed, stretcher, or operating room into a portable negative pressure room," Haas said. "The light weight, collapsibility and inexpensive materials also make it ideal for use in non-traditional settings such as field hospitals.”
In clinical testing, doctors performed tracheostomies on three intubated COVID-19 patients while using the negative pressure tent. Tents were also used on 20 emergency department patients, either with unknown COVID status or known to be COVID positive, for several procedures, including endotracheal intubations, with 100% first-pass success, high-flow nasal cannula, non-invasive ventilation and electrocardiograms. It generated up to 600 air exchanges per hour, of which only 12 are required by the Centers for Disease Control and Prevention for negative pressure rooms.
“Throughout the testing, the tents were well-tolerated by patients and received positive feedback from healthcare workers,” Haas said. “The patients were able to easily communicate with their providers and family members, and no serious adverse events occurred. I am excited about the potential of these devices to help more patients and healthcare workers at other institutions moving forward.”
The team is also in talks with the U.S. Department of Health and Human Services regarding stockpiling the tents for future pandemics, as well as for countries who are still inundated with critically ill COVID-19 patients.
“Many health systems in the U.S. have very limited negative pressure infrastructure,” said Ben Bassin, MD, chief medical officer at InspireRx and associate professor of emergency medicine at Michigan Medicine.“In most developing countries, it doesn’t even exist. We think [the AerosolVE Tent] is a scalable solution with great utility that can also allow the provision of early non-invasive respiratory therapies as well as life-saving procedures. This could possibly alleviate the need for a ventilator or allow for earlier weaning of infected patients from ventilators, enabling them to be returned to the supply chain to help alleviate critical medical equipment shortages.”
In addition to the negative pressure tent, InspireRx and MCIRCC are also developing a negative pressure system in the form of a helmet designed to enable the isolated use of heated high-flow nasal cannula or nebulized medications.
For the purposes of financial disclosure, Kota, Bassin, and Haas have equity posiitons in InspireRx.