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Cool-Headed: European trial to study induced hypothermia in brain injury

Issue 8 and Volume 34.

The Eurotherm3235 Trial is a large, randomized, controlled trial on induced hypothermia in closed traumatic brain injury (TBI) in adults, seeking to further examine the role of this intervention.„

Previously, seven feasibility studies comprising 145 patients have examined this area, according toACEP News,and the June 5, 2008,New England Journal of Medicinepublished the results of a randomized, multicenter, international trial on TBI in children. The authors concluded inNEJMthat, “in children with severe traumatic brain injury, hypothermia therapy that is initiated within eight hours after injury and continued for 24 hours does not improve the neurologic outcome and may increase mortality.”

Dr. Kees Polderman, at the Utrecht University Medical Center in the Netherlands, spoke of the study at the annual congress of the Society of Critical Care Medicine this year.

He feels past studies may not have initiated hypothermia early enough and sustained it long enough to see its full effects. “If we start cooling late, more than eight or 10 hours after the event, we may have lost an important therapeutic window. Brain edema usually peaks around 24Ï48 hours, persisting for up to 72 hours,” Polderman says.„

He explains that in the new study, “Patients will be cooled for a minimum of three days, after which they will be slowly re-warmed (1_ per 12 hours), if ICP [intracranial pressure] remains below 20 mmHg. If ICP rises during warming, the patient will again be cooled to a temperature where ICP decreases to less than 20. So the intracranial pressure will be used to guide the duration of therapy.”

This fall, investigators of the Eurotherm trial will enroll 1,800 adult patients with a closed TBI complicated by refractory increased intracranial pressure, which is defined as greater than 20 mmHg for at least five minutes and not responding to first-line treatments. The 3235 in the title of the study refers to 32_ C to 35_ C, the temperature range of the hypothermia treatment.

The randomized study will compare the effects of standard treatment versus hypothermia treatment of TBI patients admitted to an ICU. Either seven days after admission or when the ICP monitor is removed, whichever occurs first, staff will collect data for each patient in the study. Research staff will also complete the Modified Oxford Handicap Scale for patients, either on day 28, at hospital discharge or upon death. Then six months after the TBI, they will send patients the Extended Glasgow Outcome Scale.

For almost three years now, Wake County (N.C.) EMS has been inducing hypothermia for cardiac arrest patients who are non-neurologically intact after return of spontaneous circulation. (To hear about the dramatic results in Wake County, listen to “Prehospital Hypothermic Resuscitation”

When asked about EMS use of hypothermia in the Eurotherm study, Polderman says, “I would have liked to see this happening for this protocol, but I lost that discussion.”„

Improved patient outcomes could bring EMS into the mix, but experts, including Jeffrey Salomone, MD, FACS, NREMT-P, associate professor of surgery at Emory University School of Medicine and assistant medical director of Grady EMS, are skeptical about whether this is a viable modality to help brain-injured patients.
ƒAnn-Marie Lindstrom

Quick Take
What a Difference a Decade Makes„Delaware and Chicago both have systems celebrating 10-year milestones this summer. In Delaware, a statewide trauma system is credited with a 25% decrease from 1998Ï2008 in deaths for the most severely injured patients taken to Delaware trauma centers. Implemented in 2000, the program seeks to adequately match patient needs with resources available at medical facilities, according to Dr. Glen Tinkoff, Delaware State Trauma System adviser. And in Illinois, Chicago officials announced that the city_s airport system public access AED program, HeartSave, has saved 53 livesƒwith a survival rate of more than 60%ƒsince that program_s inception in 1999.

Wealth Doesn’t Mean Health
The Rural Health Care District (RHCD) of Sublette County, Wyo., is facing a critical financial crisis that may severely impact their EMS and health-care services.

“We_ve dropped our EMS budget 24% this year,” says Wil Gay, EMS director for Sublette County. “We_ve cut three full-time positions, and we_ve dropped all of our capital expenditures.”

Last year, RHCD received $7.5 million from the county to operate its EMS, two clinics and a 24-hour health-care service, but it wasn_t enough funding. With EMS costs running almost $4 million, the clinics struggle to operate with the remaining money. These clinics are critical to the county because the area lacks a hospitalƒthe nearest is 78 miles away in Jackson Hole. “We use the clinics to stabilize patients, and if it_s bad enough, they are flown out of here,” says Gay.„

To add to the fiscal woes, Medicare considers these clinics just doctor_s offices, even though they contain trauma wings with state-of-the-art emergency care equipment. “If we take someone to the clinic, and the clinic treats them, and they don_t need to go on to a hospital, we don_t get paid for our EMS services because Medicare doesn_t pay to take someone to a doctor_s office,” says Gay.

So, the county is in search of more money to fund EMS and the clinics. Typically, Sublette County_s EMS is funded through revenues from natural gas and property taxes, which have declined over recent months. Gay says he expects another 50% drop in the tax base next year.

Funding through property taxes is determined by mil levies. A mil is 0.0001 of a dollar assessed on property taxes. The county would like to raise the mil levy to four, which means a property tax increase of $19 on $100,000 of assessed value. Because of its natural gas reserves, Sublette County is considered one of the wealthiest counties in the U.S., with a per capita income of $61,411.

Recent legislation from the Wyoming Legislature will put the four-mil levy increase on the May 2010 ballot for county voters to decide. “If that gets passed, the four mil levies will be enough to sustain everything,” says Gay. “If it doesn_t, then our alternative request will be to ask the county commissioner to fund EMS out of the general fund, but ask the RHCD to manage it.” This alternative scenario, says Gay, will take approximately $4 million away from other county projects.„

It remains to be seen whether the county commissioners take on the fiscal burden or voters decide to fund EMS and the clinics through raised property taxes. “Somebody will fund us, it_s just a matter of who,” says Gay. Now it_s up to Sublette County voters to decide who that_s going to be.
ƒCynthia Kincaid

The ability to remotely disable a vehicle can prevent unauthorized users from operating it and can also gradually decelerate and stop a vehicle. Imagine if your ambulance wasn_t where you left it. Law enforcement could locate the vehicle, and if it_s in motion (say, being driven by a couple of people who are up to no good), they can disable it at a predetermined location and recover it with less damage than would likely occur during a pursuit. But what if your vehicle is hijacked while a patient is on board? What if the system malfunctions and your vehicle is disabled during a lights-and-siren transport?

Do you think it_s smart to have the ability to disable a stolen EMS vehicle?

Weigh in

Know Your Patients Heroin Abuse on the Rise
Reports of increased use of and deaths attributed to heroin use are coming from rural, suburban and urban areas in each region in the U.S., as well as from other countries. Officials in St. Louis are labeling the trend an “epidemic,” while Anchorage police are calling it their “number one concern.” Perhaps most important for EMS is that several reports note that patients who have died from or been treated for heroin abuse or overdose are not typical users. They include teenagers and young adults, college students and professionals.„

Quick Take
Double Dutch
In June, ZOLL Medical Corp. announced that the ambulance service RAV Gooi en Vechtstreek in Hilversum, The Netherlands, was the first EMS organization to equip its ambulances with the new AutoPulse Plus and the E Series, a combination that provides consistent, uninterrupted chest compressions along with timed shock delivery. This integration is viewed by some as the latest major advancement in resuscitation care. The new AutoPulse Plus does not yet have 510(k) FDA clearance in the U.S.

Names in the News
President Barack Obama announced his intent to nominateRichard A. Serino,chief of Boston EMS and a JEMS editorial board member, to serve as the deputy administrator of the Federal Emergency Management Agency Department of Homeland Security.Dr. Paul Hinchey,former deputy medical director of Wake County (N.C.) EMS, has been named the new medical director for the Austin/Travis County (Texas) Emergency Medical Systems.William K. Atkinson II, PhD, EMT-P,a member of theJEMSeditorial board and recipient of the 2004 James O. Page/JEMS Leadership Award, has been nominated forModern Healthcare Magazine_s 2009 list of the 100 Most Powerful People in Healthcare.Sunstar Paramedicsof Pinellas County, Fla., has received the prestigious Governor_s Sterling Award for 2009.„

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