Portable negative pressure tent scores FDA emergency OK to stretch newly strained COVID resources

As hospitalizations for COVID-19 rise dramatically across the country, hospitals are once again facing looming shortages of beds, ventilators and even nurses, sending them scrambling to stretch their limited resources to treat the droves of newly admitted patients.

A new emergency use authorization from the FDA is hoping to solve at least one piece of that conundrum by making a portable tent that can turn any bed, stretcher or operating table into a negative pressure room, available to hospitals across the U.S.

The AerosolVE Tent was developed by researchers from FlexSys and the University of Michigan’s Center for Integrative Research in Critical Care. It mimics the effect of a full-size negative pressure room by using a motorized filtration system to contain and filter air infected with COVID-19 aerosols within a sealed transparent tent.

Because the tents could potentially exponentially expand a hospital’s capacity to treat COVID-19 patients—rather than forcing them to ration out beds in negative pressure rooms to only the most severe cases—they can begin treating patients earlier.

As a result, the devices “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,” said Ben Bassin, chief medical officer of InspireRx and an associate professor of emergency medicine at Michigan Medicine.

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And those patients who do require ventilation can be treated successfully within the portable tents. A clinical study of the technology found that physicians were successfully able to perform tracheostomies, endotracheal intubations, non-invasive ventilation, electrocardiograms and other procedures on patients both with and without COVID diagnoses in the tents.

Additionally, the study found that each tent generates up to 600 total air exchanges per hour—well beyond the 12 per hour required by the Centers for Disease Control and Prevention’s guidelines for negative pressure rooms.

“The tent helps patients by allowing more liberal use of proven therapies while protecting healthcare workers and other patients in the process,” said Nate Haas, one of the Michigan Medicine clinicians who led development of the tent. “The lightweight, collapsible and inexpensive materials also make it ideal for use in non-traditional settings such as field hospitals.”

With the EUA in hand, FlexSys and Michigan Medicine have now formed a spinoff company named InspireRx to bring the AerosolVE Tent to market. The company has already found a high-capacity manufacturing partner and is “ready to begin distribution,” according to InspireRX CEO Sridhar Kota.

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The rising hospitalizations are caused largely by the rapid spread of the more-infectious Delta variant of the coronavirus, which now accounts for more than 80% of all new COVID-19 cases.

According to CDC data, despite widespread availability of the three approved COVID vaccines in the U.S.—and despite the fact that more than 70% of American adults have now received at least one dose of the vaccine—as of this week, the nation’s daily hospital admission rate had reached an average of 9,712.

That’s a surge of more than 31% from the previous week and represents a level not seen since early February of this year, before the vaccines were widely available. As a result, hospitals across the country are now facing shortages of nurses, as well as a variety of medical devices that include testing supplies and equipment, personal protective equipment and both continuous and non-continuous ventilators, according to the FDA.