In the cadaver lab of the University of Texas Southwestern Center for Emergency Health Sciences Program in Dallas, a small group of top EMS medical directors gathered to examine emerging advances in medical resuscitative technologies. Held one day before the February Gathering of Eagles conference, this conclave was deemed the Emerging Acute Resuscitative Technologies in Healthcare (EARTH) Symposium.
With the program put together by Craig Manifold, DO, EMS medical director, EARTH displayed some of the latest and greatest devices currently being implemented in EMS agencies, as well as those being trialed for prehospital emergency medicine use.
“We are trying to look at technology that has immediate potential for implementation,” Manifold said.
Each of the technologies was presented by the manufacturer’s representative, or in some cases by the inventor himself. Manifold asked that each presentation be accompanied by an unbiased physician commentary about how this could apply to EMS practice both in-hospital and prehospital.
The symposium was deemed a success by attendees, and there appeared to be a palpable sense of excitement. Joe Holley, MD, medical director of the Memphis Fire Department, remarked: “As important as it is to be introduced to these devices, even more important is the proper training.” Peter Antevy, MD, EMS medical director for several agencies in Florida, voiced a feeling shared by his fellow Eagles: “If this were the Oprah Winfrey show, we’d all get to take something home!” he said.
Following is an in-depth look at four of these technologies.
Company and website: 410 Medical, http://410medical.com
After years of searching for a better way to provide fluids to critically ill children, pediatric intensivist Mark Piehl, MD, said an idea for a new product came to him while he was on a ski lift in Park City, Utah with his cofounder. The resulting device, the LifeFlow Rapid Infuser, may just change the way hypovolemic patients are resuscitated.
The LifeFlow Rapid Infuser is a fluid administration tool shaped like a large water gun containing a custom syringe, valve and high-flow tubing set. After connecting the tubing to a bag of IV fluids, a provider can deliver one liter of fluid to a patient in shock in less than 5 minutes. That’s a huge improvement in fluid replacement over the standard rapid infusion setup most EMS systems use—a pressure bag device or squeezing the IV fluids bag, which can only deliver one liter in about 15 minutes or more.
Piehl is cofounder and chief medical officer of 410 Medical, the company he formed after inventing the device. He and his colleagues have been using LifeFlow at WakeMed Children’s Hospital for about the last six months.
Piehl says prospective users often ask the same question: “’Can I use it with a 24 GA IV catheter in a kid? Doesn’t it blow the vein?’ The answer is no,” he reports. “We have been successful in administering fluids using sizes from 14- to 24-gauge catheters.”
Patients in various types of shock, including sepsis, hypovolemia and anaphylaxis, benefit from a rapid infusion of fluids. Studies show that patients who receive more prehospital fluid early in cases of septic shock have better outcomes.1 Piehl and his team are currently planning two studies in the prehospital environment with two large EMS agencies in Florida and Texas.
EMS protocols in North Carolina recommend that patients with septic shock and hypotension receive an initial 500 ml bolus of fluids and then should be reassessed. Because the LifeFlow Rapid Infuser allows a provider to administer that 500 ml in minutes, patients can be reassessed more often.
“I think we are providing an opportunity for prehospital providers to treat critically ill patients in a more efficient and intuitive way than they have currently,” Piehl says.
In addition, Piehl is currently conducting simulated patient care scenarios in which the LifeFlow Rapid Infuser reduces total care time. So far in these scenarios, providers are able to administer fluids in one-third the time they would with another method. This gives the provider greater efficiency and more time to assess the patient, deliver other medications, document accurately and communicate with other caregivers.
Each LifeFlow device costs $242, and Piehl advocates that the device remain with the patient to continue using its rapid infusion method as an advantage. Piehl also argues that by treating the patient early and effectively, overall patient care costs can be recouped because earlier treatment may lead to fewer ICU days.
The LifeFlow Rapid Infuser has already been used in over 20 EMS and hospital systems, with positive feedback so far. 410 Medical is looking forward to making small modifications such as longer IV tubing, and eventually hopes to gain FDA approval for the administration of blood products, which Piehl anticipates will happen in the next few years.
“In patients with shock, our goal is to rapidly improve perfusion and prevent tissue damage in the brain, the kidneys and the heart. LifeFlow can treat hypotension and reverse shock in minutes,” Piehl says. “LifeFlow speeds the care of the sickest of the sick who may be headed for cardiovascular collapse.”
Device: Compensatory Reserve Index Monitor
Inventors: Victor Convertino, PhD, senior scientist, Combat Casualty Care Research Program, U.S. Army Institute of Surgical Research; Greg Grudic, PhD, chief technology officer and founder, Flashback Technologies
Manufacturer: Jeff Schreier, Flashback Technologies
Physician commentary: Riccardo Colella, DO, associate professor and chief, Section of EMS and Disaster Medicine, Medical College of Wisconsin
EMS providers and physicians alike are taught to monitor a patient’s vital signs for signs of shock. But in some cases, waiting for changes in vital signs proves too late: The patient may be past the point of successful resuscitation.
Measuring the body’s intravascular volume could give providers a way to recognize and treat these life threats earlier. A noninvasive pulse-ox finger sensor can measure what is termed the compensatory reserve index (CRI). By providing real-time beat-to-beat data, the CRI device can indicate a state of shock much sooner than traditional methods, helping providers intervene with appropriate lifesaving treatments.
Flashback Technologies has partnered with Victor Convertino, PhD, senior scientist with the Combat Casualty Care Research Program at the U.S. Army Institute of Surgical Research, to create this device. Convertino and his team conducted human experiments that examined arterial waveforms critical to Flashback’s creation of the CRI algorithm. The two arterial waveforms are the ejected wave, which measures the contraction of the heart, and the reflected wave, a measure of the pressure reflected back from the arterial vasculature.
The CRI device is marketed as a “fuel gauge” for the body: The number reads as a percentage, telling how much “fuel” is left in the tank and indicating how much of the body’s compensatory mechanisms are available to manage the shock state.
Convertino focused on simplicity of design for two reasons. The pulse oximeter is a device available to combat medics and the fuel gauge output gives providers a familiar concept that they could act upon.
The FDA recently cleared the device. In the meantime, the Israel Defense Forces are currently testing it as a triage decision support tool for prioritizing helicopter transport. A wearable technologies working group within military operational medicine is considering its use as a way for unit commanders to assess the combat readiness of their troops.
While there may be some limitations to using the finger for measurement, the designers are conducting tests on reflective oximeters placed on parts of the body such as the torso that will be less impacted by movement and environmental temperatures.
Convertino says that results from continuing laboratory and clinical studies are promising.
“The measurement of the compensatory reserve provides the most accurate, sensitive and specific early indicator of a patient’s trajectory to the onset of hemorrhagic shock,” he says.
As an emergency physician, Riccardo Colella is excited about the possibilities of this new “vital sign” measurement.
“CRI may be able to provoke an earlier intervention and could help EMS providers in determining an appropriate destination,” he says.
Device: Extracorporeal Life Support/Extracorporeal Membrane Oxygenation (ECLS/ECMO)
Manufacturer and Website: Maquet Getinge Group, https://www.maquet.com/us/
Physician commentary: Marc Conterato, MD, emergency and trauma, North Memorial Health; Demetri Yannopoulos, MD, professor of medicine and emergency medicine interventional cardiology, University of Minnesota (was not in attendance but provided commentary via his expertise)
Imagine the ability to sustain in the field or in the cardiac cath lab the heart and lungs of a patient in cardiac arrest. With a new device that’s about the size of a portable cardiac monitor, this ability has come true.
The CARDIOHELP device is touted by its manufacturer, Maquet Getinge, as the world’s smallest heart-lung machine. With the latest science showing that cardiac arrest patients with refractory ventricular fibrillation (VF) benefit from treatment in the cath lab, physicians such as Demetri Yannopoulos and Marc Conterato are considering the possibilities of providing extracorporeal life support (ECLS) or extracorporeal membrane oxygenation (ECMO) in a mobile unit that can meet transported patients at the door of the receiving facility.
“Technology and lifesaving treatments like compact ECMO devices can be delivered to the patient much faster than the patient can be delivered to the hospital,” says Yannopoulos, whose University of Minnesota Medical Center is currently the only hospital in the country that systematically accepts in the cath lab patients who are in refractory VF.
Currently, the thought is that a mobile ECMO unit would be on call at all times, and when alerted, would rendezvous with the patient and crew at the receiving facility to put the patient on ECMO and normalize circulation as early as possible.
That way, the cath lab can receive a patient in dire need of catheterization, but one who is not receiving active compressions from a mechanical CPR device, making the delicate procedure of stenting more difficult.
Already, Conterato and Yannopoulos are seeing in their protocols with ECMO increased rates of survival to neurologically functional discharge in these patients (~48% in the first 100 patients).
Refractory VF patients are brought to cath labs by EMS providers who have followed the protocol to identify them as such, then put on ECMO and revascularized.
“VF is a timer, so to speak, meaning there is still substrate to work with,” says Conterato. Other criteria for entry into this protocol is that the patient is between 18 and 75 years of age and has failed to be converted from the arrhythmia after three defibrillations.
While not all interventional cardiologists are trained on the ECMO procedure, Conterato sees a future in which trained physicians can use a telehealth or remote-monitoring device to provide medical direction to the field from a base station such as the hospital.
“We need to be thinking about this as we did with the whole concept of identifying trauma centers and realizing that with the correct time-sensitive resources, these are survivable conditions,” Yannopoulos says. “I predict prehospital ECMO is going to be a novel field of its own.”
Device: SAM Junctional Tourniquet
Inventors: Sam Scheinberg, MD, CEO, SAM Medical; Lance Hopman, director of research and development, SAM Medical
Company and website: SAM Medical, sammedical.com
Physician commentary: Arthur Yancey, associate professor of emergency medicine, Emory University, Atlanta, Ga.; medical director, Grady EMS Emergency Communications Center
There are likely very few EMS providers who haven’t heard of SAM: SAM splints, SAM pelvic binders and SAM chest seals are all respected products and are used in many EMS services.
So when the U.S. Army Institute of Surgical Research called on the medical device industry to invent a tool that could control femoral or inguinal hemorrhage, it was no surprise that Sam Scheinberg’s company, SAM Medical, responded. Their invention, the SAM Junctional Tourniquet, was adopted by the U.S. Army for use in the field, and also won the Army’s Major General Harold “Harry” Greene Award for Innovation, both in 2015.
The military saw success after the widespread adoption of limb tourniquets, but was presented with multiple cases of death from exsanguination in patients who underwent high limb amputations, especially in the junctional area between the torso and the upper leg.
Arthur Yancey, MD, medical director of the Grady EMS Emergency Communications Center in Atlanta, stresses the value of a device such as the SAM Junctional Tourniquet.
“Because the major blood vessels that run between those areas in the body are very difficult to access, an injury to the femoral artery is one of the most lethal wounds you can have,” he says. “It may be a rare occurrence, but it is often lethal.”
Lance Hopman is director of research and development at SAM Medical, as well as the device’s inventor. Scheinberg’s background as a trauma surgeon in Vietnam gives him a unique perspective on injuries such as these. Hopman and Scheinberg focused on the fact that blast injuries that create high limb amputations carry enough energy to also cause concurrent pelvic fractures. These injuries create high-pressure hemorrhaging that benefits from the SAM Junctional Tourniquet’s combination pelvic binder and targeted compression device (TCD).
“The pelvic binder is designed to produce the appropriate amount of circumferential force to reduce the fracture, while the bullet- and fireproof gel cylinder in the TCD can be inflated with a traditional blood pressure cuff pump to put pressure on the wound,” Hopman says.
Hopman appreciates the feedback from end-users who helped him design the product. When he realized that the device was easily saturated with water and too bulky to fit in a backpack, he re-engineered the materials.
The SAM Junctional Tourniquet can also be used to control axillary or brachial hemorrhage in an upper extremity by using the supplied strap and an extender. The device costs $349.
Hopman and colleagues are proud that training is straightforward, and that most users can apply the tourniquet and control hemorrhage in less than 25 seconds. The binder has a tactile and audible feedback mechanism so the user knows that all the slack is taken out of the device.
“That is the goal of SAM Medical: to make things that make a difference by finding simple and elegant solutions to difficult problems,” says Scheinberg. Hopman concurs: “When you are operating in a high-stress situation, the tourniquet is designed to be intuitive.”
1. Seymour CW, Rea TD, Kahn JM, Walkey AJ, Yealy DM, Angus DC. Severe Sepsis in Pre-Hospital Emergency Care: Analysis of Incidence, Care, and Outcome. Am J Respir Crit Care Med, 2012; 186(12): 1,264–71.
Hilary Gates, MEd, NRP, is a paramedic in Alexandria, Va. She is an EMT instructor and teaches in the School of Education at American University. She began her career as a volunteer with the Bethesda-Chevy Chase Rescue Squad. Gates has experience as an EMS educator and symposium presenter and is involved in quality management and training for the fire department.