Trauma Triage –
A Crucial Task, an Imperfect Art
Trauma triage — “sorting injured people based on their need for immediate medical treatment” — is one of medicine’s most difficult challenges. On the battlefield, on a paramedic run, or in a large city hospital’s ER, allocating scarce medical resources quickly and correctly is literally a matter of life and death.
The Next Generation in Trauma Triage
Vicor’s PD2i VS™ is a new diagnostic for determining risk of death in the critically injured and ill. By providing a measure of the body’s compensatory mechanisms resulting from trauma, the score obtained from a PD2i VS™ test may indicate if a trauma victim or critically ill patient is at high risk of “crashing” and in need of immediate lifesaving intervention to survive.
Importantly, the PD2i VS™ offers the speed needed to save lives, producing its first result within minutes and updates every 60 seconds.
PD2i VS™ Tested by the U.S. Army
Institute of Surgical Research (USAISR)
Mandated by Congress to reduce battlefield fatalities, the U.S. Army Institute of Surgical Research (USAISR) sought to evaluate Vicor’s PD2i VS™ against the best methodologies currently available. The results of several studies completed by the USAISR revealed that the PD2i VS™ may be more predictive of the need for lifesaving intervention than all other compared diagnostics.
In one study conducted with the USAISR, the PD2i VS™ was used to retrospectively examine 325 trauma injury victims, 20 of whom died of their injuries. Incredibly, the PD2iVS™ correctly identified all 20.
Even more important, of the 20 who died, conventional trauma triage tools identified only six of the injured for lifesaving intervention in the field.
These finding suggest that current trauma triage methods are woefully inadequate, and that the PD2i VS™ is poised to make an extraordinary contribution to combat and civilian trauma survival in the near future.
These charts of PD2i VS™ traces from two combat casualties illustrate the ability of the PD2i VS™ to triage trauma cases quickly and accurately.
Patient 565 (left) has no PD2i® values below 1.0 (the cut off for trauma) and can safely wait for treatment. Patient 321 (right), with many PD2i® values below 1.0, urgently requires lifesaving intervention.
In a trauma patient, even a single PD2i® value under 1.0 indicates urgent need of lifesaving intervention.
The very low PD2i® values of Patient 321 signify imminent risk of “crashing” and the urgent need for aggressive medical intervention. (These studies have not been reviewed by the Food and Drug Administration.)
A Critical Need in the U.S. — and Worldwide
With more than 38 million civilian emergency response calls annually in the United States alone, Vicor anticipates that the PD2i VS™ will prove just as important off the battlefield. The PD2i VS™ should prove invaluable by enabling paramedics to assign a level of severity to patients being transported to the emergency room. It is also expected to play an important role in helping medical personnel triage patients in the ER and in the hospital setting.
Additional studies are planned. Of particular promise is an upcoming trial at Massachusetts General Hospital (MGH), in which the PD2i VS™ will be tested for real-time mobile and ICU triage use in an extremely demanding emergency medical environment. The teaching hospital for Harvard Medical School, MGH is the only hospital in the United States to hold concurrent Level 1 verification for adult and pediatric trauma and burn care. A similar study is planned at the University of Mississippi Medical Center.
510(k) Marketing Clearance Expected in 2011
Study findings are currently being analyzed and compiled by the USAISR and members of Vicor’s Scientific Advisory Board. Vicor expects to submit these findings as the analysis is completed to the U.S. Food and Drug Administration (FDA) to obtain an amendment to its existing 510(k) marketing approval during the first half of 2011. Marketing of the PD2i VS™ is anticipated shortly thereafter.
PD2i VS™ Presentations and Papers
American Heart Association
Resuscitation Science Symposium 2009
November 2009
Andriy Batchinsky, MD, a researcher with the USAISR, discussed Vicor’s proprietary PD2i® nonlinear algorithm in his presentation — “Does Heart-Rate Complexity Analysis Work in the Real World? Changes in the Point Correlation Dimension of Heart Rate During Prehospital Lifesaving Interventions” — at the American Heart Association’s Resuscitation Science Symposium 2009.
The American Heart Association’s Resuscitation Science Symposium (ReSS) is an international forum for fundamental, translational, and clinical and population scientists and care providers to discuss recent advances related to treating cardiopulmonary arrest and life-threatening traumatic injury.
Smart Monitoring 2009/ATACCC 2009 Conference
August 2009
Dr. Batchinsky identified Vicor’s PD2i VS™ as a new vital sign diagnostic that more accurately risk stratifies trauma severity and the probability of survival in the critically injured during presentations at Smart Monitoring 2009 and the Advanced Technology Applications for Combat Casualty Care (ATACCC) 2009 Conference.
Both Dr. Batchinsky’s presentations provided a review of findings from studies completed under Vicor’s ongoing collaborative research agreement. “Toward Automated Detection of Life-Threatening Injury Using Comprehensive Assessment of the Electrocardiogram” was presented at the Smart Monitoring 2009 forum during the New Vital Signs, Predictive Variables and Indices panel. “Does Heart Rate Complexity Add to Traditional Vital Signs for Trauma Patient Triage?” was presented at the ATACCC 2009 Conference.
Sponsored by the Resuscitation Research Laboratory of the University of Texas Medical Branch, Smart Monitoring addresses the need for new technologies requiring innovation from government, academia, and industry by providing a forum for communication between industry representatives and expert medical caregivers. The premier scientific meeting of the Department of Defense, ATACCC addresses advances in trauma medicine and the unique medical needs of the war fighter, with a focus on identifying technologies that can meet increasingly complex operational issues.
8th International Conference on
Complexity in Acute Illness
August 2009
Dr. Batchinsky presented “Are We Listening to Music or Noise? Use of the Lyapunov Exponent for Comprehensive Assessment of Heart Rate Complexity” during Hemorrhage in Sedated Conscious Miniature Swine.
International Experts of Complexity and
Variability at the Bedside Round Table
August 2009
“Complexity in Animal Models” and “Continuous Complexity Analysis and Remote Battlefield Triage” were presented by Dr. Batchinsky.
Journal of Critical Care
June 2008
“Exploration of heart-rate complexity to determine the need for
lifesaving intervention in combat casualties”
This paper describes Vicor’s first collaborative effort with the USAISR in which ECGs from 11 combat casualties were analyzed off-line using nonlinear methods to assess the feasibility of heart rate complexity analysis to provide a new “vital sign” capable of determining the need for lifesaving intervention in the theater. The PD2i® nonlinear algorithm, one of three nonlinear methods analyzed, was the only method that correctly identified the need for lifesaving intervention in all cases, suggesting the potential utility of heart rate complexity measurement as a tool for identifying the need for lifesaving intervention in combat casualties in the theater.
Vicor’s collaboration with the USAISR is continuing. Results of additional studies will be submitted to appropriate publications when complete.
ATACCC 2008 Conference
June 2008
“Prediction of Injury Severity and Outcome in the Critically Ill Using the Point Correlation Dimension Algorithm” focused on findings from studies of the PD2i® nonlinear algorithm completed under the USAISR’s collaborative research agreement with Vicor.
6th Congress of the
International Federation of Shock Societies
&
31st Annual Conference on Shock
June 2008
Dr. Batchinsky presented findings from studies of the PD2i® nonlinear algorithm completed under the USAISR’s collaborative research agreement with Vicor in “Exploration of Heart-Rate Complexity to Determine the Need for Lifesaving Intervention in Combat Casualties.”
Learn More About Vicor Technologies’ PD2i VS™
To learn more about Vicor Technologies’ PD2i VS™, contact Vicor at 877.528.PD2i (7324), or refer to our Contact page.
