In 2002 Therapeutic hypothermia, now called Targeted Temperature Management was expected to revolutionize the treatment of patients with cardiac arrest, neonatal hypoxic-ischemic encephalopathy, stroke, and traumatic head injury. Medical equipment manufacturers rushed their versions of cooling devices into production. Therapeutic hypothermia was about to become as routine as aspirin… until December of 2013 when the New England Journal of Medicine (NEJM) published a large multinational study of adult patients suffering from cardiac arrest. This study showed no benefit in outcomes between those who received hypothermia and those who did not. During the following months, the enthusiasm for using hypothermia in adults vanished. At the same time study after study demonstrates the benefits of Therapeutic Hypothermia in newborns suffering from hypoxic brain injuries, and nowadays cooling newborns following catastrophic deliveries is a standard of care. Newborns suffering from hypoxic brain injuries who receive cooling therapy have a better survival rate, higher IQ and higher cognitive function. Is there an explanation for this discrepancy? Yes, the explanation is rather simple. Studies in animals and humans conducted prior to the early 2000s demonstrated that achievement of target body temperature of 33-35° C within minutes to about an hour following brain injury decreases mortality and improves neurological recovery. Achieving fast body cooling was a key factor. Using commercially available cooling devices target temperature can be achieved in newborns literally within minutes. However, using the same devices achieving the target temperature in adults takes hours. There are several factors explaining this discrepancy:
- Newborns suffer from brain injuries in hospitals Delivery Rooms, with Neonatal Intensive Care Units located only minutes away, whereas adults suffer from brain injuries almost exclusively outside of the hospitals. Newborns can be attached to a cooling system within minutes, whereas adults must be first resuscitated, then transported to Emergency Room, then undergo testing and stabilization and only then transferred to the Intensive Care Unit where body cooling is usually initiated.
- Newborns are not capable of maintaining a normal body and develop hypothermia even without the use of a cooling device unless they are placed into an incubator, or under a warmer, or bundled.
- Third, the most common cooling devices used at the hospitals are different plastic body wraps percolated with ice-cold water. This is where one of the biggest differences in physiology between babies and adults comes into effect: newborns’ body surface area to weight ratio is four-time higher than in adults, which means that babies lose heat through the skin four times faster than adults.
There are more than ten different hypothermia devices manufactured in the US and Europe, some based on distinctly different physiological mechanisms of cooling. Why so many? The answer is very simple: none of them satisfies clinicians.
The ideal Therapeutic Hypothermia / Targeted Temperature Management System should meet the following criteria:
- It must be capable of providing a fast rate of heat loss to achieve target body temperature within approximately an hour after the insult.
- It should be minimally invasive to reduce the spectrum of potential complications.
- The device must be unobtrusive, allowing easy access to the patient, especially during CPR.
- The device should be portable and usable in pre-hospital settings, such as ambulances or field hospitals.
- It has to be easy to operate without requiring lengthy training.
- It should allow precise temperature maintenance during cooling, maintenance of hypothermia, and re-warming stages.
None of the commercially available Targeted Temperature Management Systems meet all of these criteria. We believe, that the lack of uniformity in cooling methods combined with the inability to meet the requirements listed above is the main reason for disappointing clinical outcomes and low utilization of therapeutic hypothermia. The 2013 NEJM study was a perfect illustration of the problems with the use of hypothermia in real-life situations: people enrolled in the study had their body temperature reduced to desirable range within 6 hours after the cardiac arrest when the window of opportunity to achieve brain protection was no longer opened.
A simple, easy to use, portable and small hypothermia induction device with minimum side effects can become a standard in providing hypothermia therapy. Dr. Sergei Shushunov in collaboration with The University of Kansas Department of Engineering has designed and built a prototype body cooling device based on using hyper cold air with either manual or mechanical ventilation. This new method of inducing, maintaining and reversing hypothermia will eliminate the problems of existing types of hypothermia induction devices and will replace equipment currently in use. This revolutionary device will bring uniformity to the hypothermia equipment industry and expand the use of therapeutic hypothermia equipment to pre-hospital settings, such as ground and air ambulances as well as military field hospitals – the perfect settings for starting therapeutic hypothermia.
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