A venture-backed company spun out of the University of Michigan has developed an early warning system for hemodynamic instability in critical care settings.
The venture capital-backed startup, Ann Arbor-based Fifth Eye, has developed a noninvasive clinical tool called Analytic for Hemodynamic Instability (AHI), which it says is the first solution to establish real-time streaming data for early onset hemodynamic instability. A research study on the solution was first published in November 2020 by the International Journal of Medical Health Sciences and was recently awarded “Best Paper” at the 2020 International Conference on Health Analytics. The company is now awaiting approval from the U.S. Food & Drug Administration before marketing it to other health systems.
Ashwin Belle, Ph.D., who previously worked as an analytics architect for the Michigan Center for Integrative Research in Critical Care (MCIRCC), is now chief analytics officer and co-founder of Ann Arbor-based company Fifth Eye. The MCIRCC brings together teams of clinicians, scientists, engineers, entrepreneurs, and donors to develop technologies and therapies in the field of critical care.
Belle recently spoke with Healthcare Innovation about the problem the company set out to solve.
Hemodynamic instability is one of the most common causes of death in critically injured patients. It can happen with septic patients or car crash victims hemorrhaging, Belle said. If it happens unnoticed, it can lead to drastic outcomes. Clinicians tend to use the most common vital signs of heart rate and blood pressure to form a picture in their minds of the hemodynamic status of the patient, and they are doing this for multiple patients at the same time.
Belle said that some early warning systems use data recorded in the EHR such as heart rate and blood pressure. “That gets curated when a critical mass of data is available and a new early warning score is produced in time to identify patients at risk,” he explained. “Those tend to have limitations. Nurses have to manually enter data in the EHR before a score can be produced. Also, we have seen such systems have varying degrees of success depending on the institution. They don’t work equally well in different hospitals.”
So how is the AHI system different? “Our AHI uses a single lead of ECG, nothing else. All it is doing is looking at a single ECG waveform coming off the patient. Lots of critical care patients have an ECG lead placed on them,” Belle said. “It is existing data already being used in clinical practice that we are using to recognize hemodynamic deterioration well before it is outwardly evident.”
AHI is a separate stand-alone monitor located in a centralized area like a nursing station.
Their research found the analytic can distinguish hemodynamic instability with 100 percent accuracy — and that it can do so with a median lead time of 9.5 hours before it became obvious that a rapid response team needed to be called. An additional important aspect of the study, the company said, is that AHI was able to identify patients who were thought to be in need of a rapid response team activation but actually did not need one. Fifth Eye added that this points to the potential for AHI to decrease false alarms and to better allocate resources.
Led by serial entrepreneur and CEO Jen Baird, Fifth Eye has raised $11.5 million and licensed the technology from the University of Michigan. It is awaiting FDA approval before selling to other hospitals.
Belle said the name “Fifth Eye” could have a couple of connotations. There are basically four critical vital signs for hemodynamic status, so this could be the fifth, almost like another vital sign, he said. “That was one meaning. Another way of looking at it is one pair of eyes from the doctor, one pair of eyes from the nurse, and a fifth eye from us.”