New Intra-Nasal Cooling System May Improve Survival When Initiated Soon After Cardiac Arrest

By Circulation, PRNE
Sunday, August 15, 2010

SAN DIEGO, California, August 16, 2010 - A new portable system which cools the brain via the nasal cavity may
improve survival following cardiac arrest compared with standard care
procedures, particularly when CPR and cooling are initiated early.
Results from a recent study showed that the RhinoChill(TM) Intra-Nasal
Cooling System enabled brain temperature to reach target several hours
earlier than patients cooled in the emergency room. It is widely recognized
that the sooner brain temperature can be reduced, the better the chances of
minimizing long-term damage.

The study, published online in the prestigious peer-reviewed journal
Circulation, is the first to evaluate cooling using this system in a
randomized protocol conducted in the field and during the arrest. The
Pre-Resuscitation Intra-Nasal Cooling Effectiveness (PRINCE) study involved
200 patients with witnessed cardiac arrest across 15 locations in Belgium,
Germany, Italy, Czech Republic and Sweden, where cardiopulmonary
resuscitation (CPR) had been initiated within 20 minutes of collapse.
Patients were randomized to either intra-nasal cooling with RhinoChill along
with standard advanced cardiac life support (ACLS) care or ACLS alone until
they were either resuscitated or reached hospital, at which stage patients in
both groups were cooled.

Results showed that the target tympanic temperature of 34 degreesC, used
as an approximation of brain temperature, was reached three hours earlier in
the group receiving pre-hospital cooling with RhinoChill. Target core body
temperature was also reached two hours earlier. Among patients surviving as
far as hospital admission, 47% of patients who were cooled survived to
discharge, compared with only 31% of those who had not been cooled. Survival
rates in the 75% of patients who received CPR within ten minutes of collapse
were 59% and 29% respectively.

37% of those cooled intranasally during the arrest survived
neurologically intact, compared with only 21% of those not cooled in the
field. Neurologically intact survival rates in patients who received CPR
within ten minutes of collapse were 46% and 18% respectively, a very
significant difference.

"In this study, early cooling of the brain combined with early CPR
favorably affected outcomes, irrespective of rhythm," commented PRINCE lead
investigator, Dr. Maaret Castren of the Department of Clinical Science and
Education, Karolinska Institute, Stockholm, Sweden and the Department of
Emergency Medicine, Sodersjukhuset. "We believe that this study demonstrates
that making every attempt to initiate both CPR and intra-arrest cooling as
early as possible in the resuscitation process should be adopted."

In an accompanying editorial to the PRINCE study published in
Circulation, Dr. Lance Becker from the University of Pennsylvania observes
that: 'Although the numbers are too small to reach significance, they
provide some tantalizing cooling rates and survival trends that suggest that
improved outcomes from intra-arrest nasal cooling may be found in a larger
clinical trial.'

He also comments that: 'A strength of this approach [RhinoChill] appears
to be its relative noninvasiveness and ease of administration. It may prove
an ideal device for the emergency medical services setting.'

The RhinoChill Intra-Nasal Cooling System uses a non-invasive nasal
catheter to spray a rapidly evaporating coolant liquid into the nasal cavity.
This large nasal cavity is a heat exchanger and lies right under the brain.
The system's portability and ease of use mean that cooling of the brain can
be initiated much sooner after a cardiac arrest than with traditional
devices, which cannot be used until the patient reaches hospital.

Cardiac arrest shuts off blood flow to the brain, and death can start
within four to six minutes if circulation is not quickly restored.
Resuscitated patients may suffer brain injury due to lack of oxygen, and
because restored blood flow can cause inflammation in damaged tissues.
Cooling the brain reduces its need for oxygen and slows the damage processes.

The RhinoChill System received CE Mark Approval for marketing in European
Union countries in December 2007. It is currently planned to commence
launches in selected European markets from October 2010. The RhinoChill
System is not for sale in the USA.

For further information, please contact:

Richard Kenyon: +44-7831-569940; richard@rkpr.co.uk

For further information, please contact: Richard Kenyon: +44-7831-569940; richard at rkpr.co.uk

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