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The study, published online in the prestigious peer-reviewed journalCirculation, is the first to evaluate cooling using this system in arandomized protocol conducted in the field and during the arrest. ThePre-Resuscitation Intra-Nasal Cooling Effectiveness (PRINCE) study involved200 patients with witnessed cardiac arrest across 15 locations in Belgium,Germany, Italy, Czech Republic and Sweden, where cardiopulmonaryresuscitation (CPR) had been initiated within 20 minutes of collapse.Patients were randomized to either intra-nasal cooling with RhinoChill alongwith standard advanced cardiac life support (ACLS) care or ACLS alone untilthey were either resuscitated or reached hospital, at which stage patients inboth groups were cooled.
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Results showed that the target tympanic temperature of 34 degreesC, usedas an approximation of brain temperature, was reached three hours earlier inthe group receiving pre-hospital cooling with RhinoChill. Target core bodytemperature was also reached two hours earlier. Among patients surviving asfar as hospital admission, 47% of patients who were cooled survived todischarge, compared with only 31% of those who had not been cooled. Survivalrates in the 75% of patients who received CPR within ten minutes of collapsewere 59% and 29% respectively.
37% of those cooled intranasally during the arrest survivedneurologically intact, compared with only 21% of those not cooled in thefield. Neurologically intact survival rates in patients who received CPRwithin ten minutes of collapse were 46% and 18% respectively, a verysignificant difference.
"In this study, early cooling of the brain combined with early CPRfavorably affected outcomes, irrespective of rhythm," commented PRINCE leadinvestigator, Dr. Maaret Castren of the Department of Clinical Science andEducation, Karolinska Institute, Stockholm, Sweden and the Department ofEmergency Medicine, Sodersjukhuset. "We believe that this study demonstratesthat making every attempt to initiate both CPR and intra-arrest cooling asearly as possible in the resuscitation process should be adopted."
In an accompanying editorial to the PRINCE study published inCirculation, Dr. Lance Becker from the University of Pennsylvania observesthat: 'Although the numbers are too small to reach significance, they providesome tantalizing cooling rates and survival trends that suggest that improvedoutcomes from intra-arrest nasal cooling may be found in a larger clinicaltrial.'
He also comments that: 'A strength of this approach [RhinoChill] appearsto be its relative noninvasiveness and ease of administration. It may provean ideal device for the emergency medical services setting.'
The RhinoChill Intra-Nasal Cooling System uses a non-invasive nasalcatheter 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 canbe initiated much sooner after a cardiac arrest than with traditionaldevices, which cannot be used until the patient reaches hospital.
Cardiac arrest shuts off blood flow to the brain, and death can startwithin four to six minutes if circulation is not quickly restored.Resuscitated patients may suffer brain injury due to lack of oxygen, andbecause 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 EuropeanUnion countries in December 2007. It is currently planned to commencelaunches in selected European markets from October 2010. The RhinoChillSystem is not for sale in the USA.
For further information, please contact:
Richard Kenyon: +44-7831-569940; [email protected]
SOURCE Circulation
