INTRODUCTION


Pre‐Hospital Therapeutic Hypothermia or TH therapy has been used by care‐ givers for many years. When combined with established in‐hospital cooling protocols, outcomes of patients suffer‐ ing from neurologic injury have dramat‐ ically improved.


Current approaches to TH focus on reducing core body temperature by attempting to protect the most vulner‐ able and important body organ, the brain. It is well documented that the earlier TH is initiated after insult the better the outcome; however, ultra early cooling is difficult to implement. EMS & hospital personnel are often challenged with resuscitating critically ill patients and conventional methods of systemic cooling are often cumber‐ some and of questionable efficacy. The Sandhu Cerebral Cooling Collar (SCCC) offers an effective solution for the induction of mild cerebral hypother‐ mia at the earliest onset after neurolog‐ ic injury. The SCCC is an easy to apply solution that can be implemented by EMS and hospital personnel which results in a continuum of care from scene to the ED, and until the patient is transported to the ICU, where most cooling protocols begin. Proper use of the SCCC will insure cerebral protection during this critical period.


A recently conducted pilot trial at a national research center, In Focus Research (Raleigh, North Carolina) tested normal, healthy volunteers using the SCCC and recorded tempera‐ ture measurements that demonstrated favorable outcomes in selectively cool‐ ing the brain.


As a result, it is suggested that the SCCC may be a simple, non‐invasive method for neuroprotection after insult by selective brain cooling.


THERAPEUTIC HYPOTHERMIA CHALLENGES


Current TH therapies include surface cooling with commercially available ice packs as well as the infusion of cold saline; however, there are challenges to each of these. They include:


1. In the pre‐hospital setting ice filled “Igloo” coolers are unreliable.


2. In vehicle refrigerators are costly and taxing on the vehicle power supply.


3. Ice packs pose skin irritation and degradation when worn over time.


4. 70% of commercially available ice packs contain ammonium nitrate.


5. Saline rapidly transitions to ambi‐ ent temperature.


6. TH therapies take time to assem‐ ble and completely occupy the time of one rescuer.


The Life Core’s SCCC system answers all the above challenges.


MATERIALS & METHODS The Sandhu Cerebral Cooling Collar,


also known as the SCCC, integrates technologies relating to cervical immo‐ bilization and to therapeutic induction of mild cerebral hypothermia by tran‐ scutaneous cooling of oxygenated blood through the carotid arteries. When cooled, the carotid arteries vasodilate which allows for greater countercurrent heat exchange. The method of cooling used with the SCCC is selective, non‐invasive, and targeted towards inducing mild hypothermia of the brain, within a range of 1‐3 degrees Celsius temperature reduction to achieve the desired neuroprotective


Current TH Therapies 3 Ice filled Igloo coolers In vehicle refrigerators Ice packs directly on skin


Ice pack ingredients contain ammonium nitrate


Takes time to assemble and absorbs ambient temperature rapidly, occupies one rescuer


Infusion of saline through a catheter or I/O needle


state.


The SCCC is equipped with a hinged‐ door that provides for complete access to the patient’s neck and carotid area. The anterior door provides access to accommodate the Life Core Extreme Cooling Element (EXCEL) pack. Upon activation EXCEL provides for accelerated cooling for extended peri‐ ods of time. In addition, the cloth‐lined feature of the EXCEL, eliminates the threat of patient skin irritation. The SCCC has been registered as a Class 1 device with the US Food & Drug Administration and has been assigned a registration #3008284143.


Nine healthy volunteers participated in a trial using the SCCC. Informed writ‐ ten consent was obtained from each participant before enrolment. The SCCC was applied to subjects in a test facility under the supervision of an independent test auditor. Testing and medical protocols were written and strictly adhered to with legal and safety briefings. All subjects were medically cleared and agreed to the testing pro‐ cedures. Subjects were briefed and study was implemented as follows:


1. Subjects were placed in a supine position.


2. The SCCC system was applied to (CONTINUED ON PAGE 34)


Life Core SCCC systems Space saving and zero maintenance


Saves expense of costly machines and “shore line” placement


EXCEL cooling element is cloth-lined and avoids skin irritation


EXCEL cooling element is non-toxic and non-caustic with an indefinite shelf life


Rapidly applied freeing up rescuer, pro- vides stabilization of advanced airway, and immediate TH therapy


SCCC is a non-invasive solution


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