Wireless Vital Signs Monitor for trauma victims enters clinical trial phase

A collaboration among a medical device innovator, the U.S. Army Institute of Surgical Research (ISR), the nonprofit National Trauma Institute and the State of Texas enters its final phase as the FDA-approved Wireless Vital Signs Monitor (WVSM) begins clinical trials this month in the Memorial Hermann Medical Center emergency department and on Houston Life Flight. This clinical trial will determine the benefits of WVSM over existing systems.

The WVSM is small and light, weighing a little over a pound, whereas monitors in use now are bulky and provide medics with only a basic set of vital signs, not real information about the status of the patient. In this clinical trial, the WVSM will be strapped onto the patient's arm and used to keep tabs on the trauma victim during emergency air transportation and in the ED. The device uses a wireless technology to transmit vital signs to a PDA, smart phone or laptop, and the receiving station then analyzes the data and runs algorithms to help medical personnel determine if and when emergency intervention is needed.

"If a patient has lost a lot of blood, standard vital signs may not fully represent how he is doing," explained Jose Salinas, Ph.D., Research Task Area Program Manager, Combat Critical Care Engineering at the ISR. "Our bodies compensate for blood loss through different mechanisms that can mask the true severity of the injury." Dr. Salinas' team explored many different approaches for calculating need for lifesaving interventions to arrive at algorithms based on artificial neural networks.

In military settings, the WVSM will also serve the crucial function of passing on information about patients throughout the evacuation chain. From point of injury to helicopter evacuation to combat support hospital and through higher levels of care, the monitor will store all data and interventions from the moment it is strapped onto a wounded warrior.

The device's clinical trial phase caps a long process that was supported by a grant from the Texas Emerging Technology Fund (ETF), awarded to the nonprofit National Trauma Institute (NTI) to manage the innovation partnership between Dr. Mark Darrah at Athena GTX, who developed the device, and Dr. Salinas at the ISR.

The clinical trials will continue throughout 2012, measuring "time to first intervention" in the emergency department. "If we can show that the wireless system decreases the time to first intervention, we can make the case that it will also lead to better patient outcomes," said John Holcomb, M.D., FACS, Director of the Center for Translational Injury Research at UTHSC Houston. Dr. Holcomb, an NTI board member and retired U.S. Army Colonel, was part of the development team for the WVSM system while he was commander of the ISR. Dr. Holcomb was instrumental in bringing this state-of-the-art medical device research and development to the State of Texas.