JBSA-FORT SAM HOUSTON –
Researchers at the U.S. Army Institute of Surgical Research on Joint Base San Antonio-Fort Sam Houston are conducting a clinical trial on the Compensatory Reserve Index to gather data for submission to the Food and Drug Administration for 510(K) clearance.
The FDA uses the 510(K) pre-market submission to ensure that a medical device is safe for use on patients and can then be made commercially available.
The tactical combat casualty care research task area team, led by Victor A. Convertino, Ph.D., will use a lower body negative pressure chamber during the clinical trial to gather the data. Research participants are placed in the LBNP chamber which draws their blood to their lower bodies.
"It's a way of 'bleeding' someone without taking a drop of blood," Convertino said. Convertino developed the CRI in collaboration with colleagues at the University of Colorado, Children's Hospital Denver and Flashback Technologies Inc. It uses an algorithm that is designed to take information from a patient using a non-invasive finger pulse oximeter and gauges whether immediate medical attention is needed, even though the patient may seem alert and responsive.
"That's because the human body has many physiological mechanisms that compensate to maintain a constant blood pressure when there's internal bleeding," he said. "The blood pressure can seem stable, but the patient can be losing the ability to continue to compensate.
"When the patient gets to the end of the compensation, their blood pressure falls rapidly, referred by some as 'falling off a cliff,' and now they are in shock."
That's because medics, corpsmen and emergency medical service providers have traditionally been trained to watch patient's blood pressure. With this new technology they will get a better idea of how the body is naturally compensating and when a patient is in danger of going into shock.
In order to measure a patient's reserve to compensate, Convertino focused on an arterial waveform that is created by blood going out into the vessels.
"Each time the heart pumps, a pulse of blood creates an arterial pressure wave that is actually made up of two waveforms," he said. "The first waveform called the ejected wave is caused by the blood leaving the heart, and the second wave called the 'reflected' wave is caused by the blood being reflected off the arteries back to the heart. These events happen so quickly that the two pressure waves are merged so they look like a single waveform.
"So with newly advanced computer technologies, we now have the capability to measure features of each arterial waveform that reflect the sum of all mechanisms of compensation that affect the heart (ejected wave) and the arteries (reflected wave)," Convertino said. "We call this measurement the 'compensatory' reserve.
"If you're monitoring blood pressure in a patient with internal bleeding, you may not notice the problem because the body is compensating for the blood loss," he said.
"The algorithm can gauge how much the body is compensating and how much the body has left to compensate."
Convertino said that this technology is so new that they really have to demonstrate that it works.
"No one has done this before, but we're pretty confident that we can meet FDA requirements," he said.