Dallas to test resuscitation techniques

[Ridryder 911]

Anyone have any more detail of this ?

Dallas to test resuscitation techniques

by

Dallas is one of 10 North American cities chosen to participate in the largest-ever clinical trial of resuscitation methods, a designation local doctors and researchers say will make North Texas one of the "safest places in the country to have a heart attack or a car wreck."

The $50 million federally funded study, which kicks off this summer and will involve about 15,000 cardiac arrest patients and 5,000 severe-trauma victims over the next three years, will compare traditional life-saving techniques with two new resuscitation treatments – a unique airway valve and a highly concentrated saline solution.

UT Southwestern Medical Center is coordinating Dallas' resuscitation research center, which will train paramedics and collect data from more than 30 Dallas-area hospitals and 11 emergency-response agencies participating in the National Institutes of Health-sponsored study.

"The implications of this thing are tremendous," said Dr. Paul Pepe, chief of emergency medicine at UT Southwestern. "We're a center of excellence, and that's why they chose us."

The study means Dallas heart attack and trauma victims being treated by paramedics at the scene or in ambulances will be randomly assigned to the traditional treatment or to a trial treatment.

Starting in August, local trauma victims who lose significant amounts of blood or have severe brain injuries will receive a standard saline solution or one of two high-concentrate solutions, which experts believe more quickly restore circulation in bleeding patients.

By November, heart attack victims will be treated with a traditional ventilator or one fitted with an "inspiratory threshold device." The device is an airway valve that creates a vacuum to return blood to the chest during CPR, improving flow to the brain and heart.

The study is double blind, meaning the thousands of North Texas paramedics being trained for the trial won't know which kind of saline they're using or whether a ventilator is fitted with an active or inactive airway valve. The equipment will be specially coded for researchers.

In the U.S., about 1,000 people a day die prematurely because of heart attacks; in Dallas, more than 1,000 people suffer cardiac arrest each year.

Trauma is the leading cause of death for children and people younger than 45. In Dallas County, about 3,500 people die of severe injuries every year.

Traditionally, it's been difficult to conduct clinical trials on patients who are severely injured because they are too sick or incapacitated to give informed consent, said Dr. Joseph Minei, vice chairman of surgery at UT Southwestern and an investigator in the study.

In this trial, each patient will receive, at a minimum, the current standard of care. But residents concerned about being subject to a trial without their consent can call to receive a special wristband.

"What we're doing now is letting the community know we're doing this trail," Dr. Minei said. "This is an opportunity for Dallas, and for the whole trauma system, to really deliver a potentially lifesaving technique."

Both trial techniques have proved to be safe and have some lifesaving effects in smaller-scale studies in the U.S. and Europe, Dr. Pepe said.

The concentrated saline is equivalent to two bags of normal saline and can be administered faster, potentially reducing brain swelling and preventing organ failure in trauma victims, said Dr. Ahamed Idris, principal investigator for Dallas' resuscitation research center.

In North Texas, Dr. Idris estimates about 500 patients per year will receive the "hypersaline."

The airway valve has been shown to double blood flow during cardiopulmonary resuscitation by drawing blood up from the legs and abdomen, he said. It will probably be used on 1,000 North Texas cardiac arrest patients per year.

Permanent brain damage can occur within four minutes after a person stops breathing.

"We hope to be able to answer the most important question," Dr. Idris said. "Will these treatments return people to a normal life?"

The trial will be the first of several NIH resuscitation studies over the next five years to determine whether particular treatments improve survival and hospital discharge rates. Whether they prove effective, Dr. Pepe said, the mere attention and focus of a trial this size will seriously benefit Dallas heart attack patients and accident victims.

"Experience has shown us that survival rates go up significantly in cities that provide this kind of research initiative for their citizens," he said.

UT Southwestern was one of more than 100 city-university partnerships to apply for the resuscitation study.

Other U.S. regions chosen include Birmingham, Ala.; Iowa City, Iowa; Milwaukee; Portland, Ore.; Seattle and King County, Wash.; Pittsburgh; and San Diego. In Canada, Toronto and Ottawa were selected for the trial.

Dallas-area residents who don't want to be included in the trial without their consent can opt out by calling 214-648-6726.

[AZCEP]

If this goes as advertised, it will be a good thing.

[Scaramedic]

Here's a few local stories on it Rid...

http://www.ohsu.edu/ohsuedu/newspub/releas...50206trauma.cfm

http://www.ohsu.edu/emergency/roc/hypertonic.htm.

http://www.uwmedicine.org/Facilities/Harbo...pertonicSaline/

...and some national stories.

http://www.medscape.com/viewarticle/493668

http://circ.ahajournals.org/cgi/content/fu...ha;108/18/e9047

http://www.touchcardiology.com/articles.cf...601&level=2

http://www.jems.com/medical-clinical/articles/104188/

http://www.defrance.org/artman/publish/article_1581.shtml

Peace,

Marty

:joker:

[vs-eh?]

http://www.emtcity.com/phpBB2/viewtopic.ph...p;highlight=roc

I posted about this months ago, and Rid, you were the only one to reply .

My service is one of the study cities.

We recently recieved the standing orders regarding the hypertonic saline trial, though have not as yet recieved the study fluid. We can use the study fluid as soon as we get it.

We do not have the ITD yet, I believe we get that in the fall.

I have the standing orders for the study fluid at work and can post them if people want.

[Ace844]

Isn't Seatle doing this study as well the intra-cardiac ice-cold saline in Cardiac Arrest?

[Just Plain Ruff]

I have an issue with the following statement that I read in the article

in the original post!!

Dallas is one of 10 North American cities chosen to participate in the largest-ever clinical trial of resuscitation methods, a designation local doctors and researchers say will make North Texas one of the "safest places in the country to have a heart attack or a car wreck."

Being a cynic --- safest but I think that only applies to the people chosen to get the new treatment. If you don't get the new treatment then it's just like any other city don't you think

The study is wonderful and in the end it will benefit all of us and I'm all for it. I just want to be the one who gets the test treatment and not the treatment that we would get anywhere.

[Ace844]

I have an issue with the following statement that I read in the article

in the original post!!

Dallas is one of 10 North American cities chosen to participate in the largest-ever clinical trial of resuscitation methods, a designation local doctors and researchers say will make North Texas one of the "safest places in the country to have a heart attack or a car wreck."

Being a cynic --- safest but I think that only applies to the people chosen to get the new treatment. If you don't get the new treatment then it's just like any other city don't you think

The study is wonderful and in the end it will benefit all of us and I'm all for it. I just want to be the one who gets the test treatment and not the treatment that we would get anywhere.

well said :cheers:

ACE

[Ace844]

here's the press release from the the NIH::

(FOR IMMEDIATE RELEASE http://www.nih.gov/news/pr/mar2006/nhlbi-24.htm

Friday @ March 24, 2006

CONTACT:

NHLBI Communications Office

301-496-4236

New Federally Funded Research Program Aims to Improve Survival from Cardiac Arrest and Severe Trauma)

A young mother is unconscious and bleeding from internal injuries caused by a highway accident. A soldier is severely injured in a roadside explosion. A 50-year-old man suffers a cardiac arrest as he gets ready for work. For the “real” counterparts of these made-up case histories, the chance of survival from life-threatening injury and cardiac arrest is dismally low. Many more could survive if only they could be sustained long enough to reach a hospital alive. However, most cardiac arrest victims die before they reach the hospital, and traumatic injury is a top killer in North America. With the launch of a massive research program funded by the National Institutes of Health (NIH) and other federal and Canadian agencies, scientists hope to learn the best ways to improve survival chances from cardiac arrest and severe trauma.

The “Resuscitation Outcomes Consortium” (ROC) will conduct collaborative clinical trials of promising new treatments for cardiac arrest (the stopping of the heartbeat) and severe traumatic injury. Along with Emergency Medical Services (EMS) agencies, ROC will involve public safety agencies, regional hospitals, community healthcare institutions and medical centers in 11 regions in the United States and Canada and as many as 15,000 patients over a 3-year period. Communities involved in ROC will learn about the study in a comprehensive community education effort to be conducted over the next 6 months to a year.

“Surviving traumatic injury and cardiac arrest is a serious public health issue. Tens of thousands of Americans die each year from sudden cardiac arrest and trauma. The good news is that there is a growing body of research — basic research and small studies — that suggests a significant number of these people can be saved,” said Elizabeth G. Nabel, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI) of the NIH, the lead federal sponsor of the research effort.

Other funding agencies include the U.S. Department of Defense, the NIH’s National Institute of Neurological Disorders and Stroke, the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, Defence Research and Development Canada, the Heart and Stroke Foundation of Canada, and the American Heart Association. The initial funding commitment to the Consortium is $50 million.

“This is the first time we have used large-scale clinical trials to improve the treatment of patients with traumatic injury and cardiac arrest. Similar studies in patients with heart attack and heart failure have answered questions about the best treatments. As a result, we’ve seen greatly improved survival for these disorders. That’s what we want to do with cardiac arrest and traumatic injury,” said Myron Weisfeldt, M.D., professor and chair of internal medicine at Johns Hopkins University and chair of the steering committee for the research effort.

All of the interventions to be tested in the new program will have been shown in smaller, single center studies to be safe and to potentially have a life-saving effect. According to Weisfeldt, the Consortium’s testing of new techniques will provide the large-scale proof of effectiveness needed to support widespread adoption and use.

An important goal of the ROC will be the evaluation of interventions in terms of benefit to cognitive outcomes, as the ultimate goal of resuscitation is to return victims to their prior functional capacity.

The first treatments to be tested will be highly concentrated forms of a saline solution similar to the body’s own fluids. Typically, in the crucial early minutes before blood transfusions can be safely administered in hospital, trauma patients receive normal saline solution intravenously in the field to compensate for blood loss and buy time. In the new trial, trauma patients with either signs of blood loss or severe brain injury will receive one of three saline solutions — standard normal saline, high concentration saline, or high concentration saline with dextran, a circulation-enhancing substance. The two concentrated solutions are designed to compensate for blood loss more effectively, lessen excessive inflammatory responses and prevent brain swelling. These effects in turn could potentially lead to a reduction in organ failure for patients with major blood loss and improved function for patients with brain injury.

The second study will test a device to enhance blood flow during CPR. This device is a one-way valve that fits between the airbag used to introduce air into a person in cardiac arrest and the flexible plastic tube that goes through the nose or mouth and into the lungs to help with breathing. The valve can also be used with a facemask that goes over the patient’s nose and mouth. During CPR, the one-way valve creates a small vacuum inside the patient’s chest, which increases the return flow of blood to the heart.

Other possible future studies include testing of new drug approaches to aid resuscitation from cardiac arrest and evaluation of novel strategies to control hemorrhage.

There are an estimated 330,000 out-of-hospital cardiac deaths each year in the United States. Most of these are from sudden cardiac arrest, although the exact numbers are not known. In cardiac arrest, the heart stops beating effectively, blood does not circulate and no pulse can be felt. The victim collapses suddenly into unconsciousness. Heart attacks, which are caused by a blockage of a coronary artery, can sometimes lead to cardiac arrest. A common underlying cause of sudden cardiac arrest is an abrupt disorganization of the heart’s rhythm called ventricular fibrillation, which can be triggered by a heart attack or can just represent a catastrophic rhythm disturbance. Unless cardiac arrest victims are treated within minutes (by defibrillation to shock an abnormally beating heart back into normal rhythm or CPR followed by or in conjunction with other procedures), they will die.

Severe injury is also a major public health problem. It is the number one killer of both children and young adults up to age 44. As a disease of young people, it is also the leading cause of life years lost. In 2002, there were over 161,000 fatal injuries in the United States. The leading causes of death following injury are brain injury, blood loss, and organ failure from excessive inflammation.

In addition to rigorous review by an NHLBI-convened independent review group, the clinical trials of the new Consortium will be conducted under strict FDA guidelines that allow for patients in life- threatening situations to participate in research without individual consent at enrollment. The guidelines specify criteria that must be followed for a study to have an exception from informed consent. These include:

Approval by an institutional review board (IRB), a committee of experts and lay people established to review research.

Consultation with the community.

Public disclosure of the study’s design before the study begins and when the study is over to share results.

Notification of patients who were involved in the research.

Oversight by an independent group of experts charged with monitoring the research for safety.

Each site’s IRB will decide how best to inform the community, recommending approaches that might include town meetings, newspaper notices, random digit dialing surveys, and meetings with groups at high risk of either cardiac arrest or trauma — such as local motorcycle clubs. In order to inform future studies involving exceptions from informed consent, the community consultation process used in ROC will be evaluated in at least one ancillary study.

“There is a high probability of benefit for patients participating in these trials,” said Joseph Ornato, M.D., the Consortium’s co-chair for cardiac arrest and chairman of the Department of Emergency Medicine at the Virginia Commonwealth University Medical Center in Richmond, VA. “Not only have these therapies been shown to be potentially life-saving, but also EMS personnel involved in the research will be trained in the most up-to-date and effective methods of emergency treatment.”

According to Tracey Hoke, M.D., Sc.M., NHLBI project officer for the ROC, “A federal exception of informed consent can only be granted when patients are in a life-threatening situation, when obtaining individual informed consent is impossible, and when current therapy is unproven or unsatisfactory. The most critical stipulation of the exception is that there must be the potential for direct benefit to the patients enrolled. In the case of ROC, this means that preliminary evidence of direct survival benefit must be shown prior to the development of any trial.”

“These initial studies, and those that follow, will change the way all providers of trauma care, military and civilian, care for the most critically injured,” said COL John Holcomb, MD, the consortium co-chair for trauma, and the Commander of the US Army Institute of Surgical Research, San Antonio, TX. “For the first time we will know, based on large and well designed studies, what interventions really make a difference.”

In a typical study scenario, a first responder will arrive at the scene of the cardiac arrest or trauma and confirm the patient’s diagnosis. The emergency medical technician (EMT) will then assess whether the patient meets the entrance criteria for the study and if so, treat the patient with the study intervention.

Since the studies will be blinded, the EMTs in the field will not know which treatment the patient receives. For example, in the first consortium study testing the concentrated saline solutions, all solutions of saline to be administered to patients will look alike, although they will be numbered for later identification and analysis by the study’s scientists.

In addition to the clinical trials, the Consortium is also currently enrolling patients into a database of all cardiac arrest and trauma events. “This is the first multi-city comprehensive database with information about how field treatment leads to patient survival,” said George Sopko, M.D., deputy project officer on the study and a medical officer with NHLBI.

The study is coordinated by investigators at the University of Washington, Seattle, Principal Investigator: Al Hallstrom, Ph.D.

The participating cities include:

Birmingham, AL: The Alabama Resuscitation Center is coordinated through the University of Alabama at Birmingham (Central and possibly Northern Alabama). Principal Investigator: Tom Terndrup, M.D.

Dallas, TX: The Dallas Center for Resuscitation Research is coordinated through the University of Texas Southwestern Medical Center (Dallas and surrounding cities to participate). Principal Investigator: Ahamed Idris, M.D.

Iowa City, IA: The University of Iowa Carver College of Medicine-Iowa Resuscitation Network is coordinated through the University of Iowa (includes 10 cities throughout Iowa). Principal Investigator: Richard Kerber, M.D.

Milwaukee, WI: The Milwaukee Resuscitation Research Center is coordinated through the Medical College of Wisconsin. Principal Investigator: Tom Aufderheide, M.D.

Ottawa, Ontario/Vancouver, BC (counts as two regions): The University of Ottawa/University of British Columbia Collaborative RCC is coordinated through the Ottawa Health Research Institute, University of Ottawa, Ontario and St. Paul’s Hospital, University of British Columbia (includes additional 20 cities). Principal Investigator: Ian Stiell, M.D., Co-Principal Investigator: Jim Christenson, M.D.

Pittsburgh, PA: The Pittsburgh Resuscitation Network is coordinated through the University of Pittsburgh Medical Center (includes several suburbs). Principal Investigator: Clif Callaway, M.D., Ph.D.

Portland, OR: The Portland Resuscitation Outcomes Consortium is coordinated through the Oregon Health and Science University (includes 4 counties). Principal Investigator: Jerris R. Hedges, M.D., MS.

San Diego, CA: The UCSD-San Diego Resuscitation Research Center is coordinated through the University of California, San Diego (entire county). Principal Investigator: David Hoyt, M.D.

Seattle and King County, WA: Seattle-King County Center for Resuscitation Research at the University of Washington. Principal investigator: Peter Kudenchuk, M.D.

Toronto, Ontario: The Toronto Regional Resuscitation Research out of hospital Network is coordinated through the University of Toronto (includes areas surrounding Toronto). Principal Investigator: Arthur Slutsky, M.D., Co-Principal Investigators: Laurie Morrison, M.D. and Paul Dorian, M.D.

To interview NHLBI’s Dr. Tracey Hoke, ROC project officer or NHLBI’s Dr. George Sopko, ROC deputy project officer, contact the NHLBI Communications Office at 301-496-4236. To interview Dr. Weisfeldt or Dr. Jeremy Sugarman, ROC ethicist and Harvey M. Meyerhoff Professor of Bioethics and Medicine with the Phoebe R. Berman Bioethics Institute and Department of Medicine Johns Hopkins University, call David March, Media Relations and Public Affairs, Johns Hopkins Medicine at 410-955-1534. To interview Dr. Ornato, call 804-828-7184. To interview COL Holcomb, call 210-916-2720.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: www.nhlbi.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

[Ridryder 911]

I understand the Polyheme, but what device is used for increasing inner-thoracic pressure (vacuum) ?.. Has anyone used this and the specific medication(s) they are proposing, Still a little vague and mysterious for such as scientific test.

This will be interesting read, if Pepe is involved (remember the MAST catastrophe study).

Be safe,

R/r 911

[Just Plain Ruff]

I always admired Paul Pepe but he always reminded me of someone who had just come in from the jungle after a 3 year stint with the natives teaching them the finer points of doing a needle decompression in the deepest parts of South america.

He seems like he'd be a great person to sit down with and shoot the sh*t with.