Pilot Study Underway to Investigate Use of Attune Medical’s ensoETM for COVID-19 Treatment

A pilot study using Attune Medical’s ensoETM, a thermal regulating device, has begun enrollment in the first study to evaluate the impact of core warming on the length and severity of illness in hospitalized patients with COVID-19. The randomized, single-center pilot study, Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation, is being conducted by physicians at Sharp Memorial Hospital in San Diego, California, and will investigate whether core warming can improve the recovery of patients diagnosed with COVID-19 and decrease their time spent on mechanical ventilation (breathing support).

There is growing evidence that fever, in general, may be beneficial, and that elevated body temperature enhances immune function while impeding the activity of many pathogens, including a wide range of viruses. The SARS-CoV-2 virus that causes COVID-19 may be particularly temperature-sensitive, and elevated body temperatures could negatively impact its ability to enter cells.

In the most critically ill patients with COVID-19, however, fever is often absent. This pilot study will examine whether proactively increasing core temperature in critically ill patients that require breathing support will reduce patients’ viral load, decrease the duration of breathing support needed, and improve lung condition and survival. It will randomize a total of 20 patients diagnosed with COVID-19 on mechanical ventilation, half to standard care (no warming), the other half to treatment with core warming.

The study is led by a pulmonologist and critical care physician David Willms, MD, building off of work on external warming by Drs. Anne Drewry and Richard Hotchkiss at Washington University in St. Louis. It is thought that directly warming the patient’s core, where much of the viral damage occurs in the heart and lungs, may provide further benefits while avoiding the physiologic stress of skin and whole-body warming.

“There have been data suggesting the benefits of fever and of warming patients with infectious conditions for a long time, but to date, just one randomized controlled study has been performed to formally investigate this treatment option. We look forward to further advancing this important area of medicine with new technology, and potentially transforming the way we care for these critically ill patients,” said Dr. Willms.

Attune Medical’s ensoETM is a single-use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement doesn’t impede patient access during surgery and allows gastric decompression and administration of fluids and medications.

“We are particularly passionate about research initiatives like this that could help improve patient outcomes,” commented Dr. Erik Kulstad, the inventor of the ensoETM and a practicing Emergency Medicine physician. “We see first-hand the devastating toll this disease is taking, and are grateful to have the chance to help make a difference.”

Attune Medical has developed a novel medical device technology that simplifies access to the patient’s core to efficiently control temperature and is the only device FDA-cleared for use in the esophagus for whole-body temperature management. The ensoETM device is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature and can be rapidly placed by most trained healthcare professionals.