Whether on the battlefield, in the delivery room or ER, recognizing severe blood loss can be challenging and often comes too late.
Humans are built to compensate for blood loss, tightening up vasculature or increasing heart rate to keep traditional vital signs stable. But, when the deficit becomes too extreme, the vital signs begin to change and the patient’s condition rapidly worsens.
Hemorrhage is the direct cause of death in approximately 40 percent of all trauma-related deaths, making it the leading cause of death from trauma in both civilian and military settings.
As a trauma surgeon with experience working with the military, Dr. Steve Moulton began to wonder what data non-invasive technology could reveal in vital signs and waveforms.
Years ago, Moulton collected data from a U.S. Army study that simulated blood loss and inquired if anyone at the Department of Computer Science at the University of Colorado could analyze the data.
Researchers Greg Grudic, PhD, and Jane Mulligan, PhD, were able to use an algorithm they developed for a robot to decipher the pulse oximetry data. The algorithm was able to dig deeper into the data, identifying trends unseen to human eyes.
From there, Moulton and Grudic launched Flashback Technologies as they attempted to develop what they called a fuel-gauge for blood loss.
Flashback developed the Compensatory Reserve Index, a new vital sign that monitors a patient’s blood volume. The technology, cleared by the FDA in 2018, trends volume loss and provides real-time monitoring of a patient’s response to resuscitation.
“The technology has the ability to tease apart the waveform data and develop a model that is able to trend blood loss from normal to collapse,” Moulton, now the Director of Pediatric Trauma and Burn Services at Children’s Hospital Colorado said.
Medical professionals monitor the CRI on Flashback’s CipherOx CRI M1, a lightweight, field-ready monitoring device that displays blood volume like a fuel gauge.
Flashback has received nearly $10 million in grant funding from the Department of Defense and over $7 million in private capital to develop the algorithm and device.
Since receiving FDA clearance last year, the company is beginning to commercialize with customers including leading hospitals, EMT professionals, researchers and U.S. Army Special Forces.
Moulton said Flashback’s technology has a clear use in the modern battlefield but also in hospitals, especially surrounding childbirth.
Hemorrhage is one of the leading causes of death for women in childbirth, most often because the blood loss isn’t caught soon enough, Moulton said.
“The amount of blood loss is just not being detected and not being recognized,” he said, adding that the CipherOx is currently being used in the Fetal Care Center at Colorado Children’s Hospital.
Medical publication The Journal of Special Operations has also noted the potential applications of CRI in measuring hydration status.
As technology’s capabilities expand, Moulton sees a huge opportunity to integrate machine learning and artificial intelligence with traditional healthcare to improve outcomes for patients.
“There’s no question that machine learning and artificial intelligence will play a major role in healthcare. We’ve demonstrated here that there is information in the waveform data that humans can’t see,” he said. “This is going to make a difference in outcomes.”
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