The first randomized intra-arrest cooling study performed using a novel intra-nasal cooling method showed much faster and earlier cooling in treated patients and significantly higher neurologically intact survival - to - discharge rate in many patients. The Pre-Resuscitation Intra-Nasal Cooling Effectiveness (PRINCE) study involved 200 patients and was conducted by 15 Emergency Medical Systems (EMS) in Belgium, Germany, Italy, Czech Republic and Sweden. The aim was to determine safety and efficacy of intra-nasal cooling during ongoing resuscitation of cardiac arrest patients even before the return of circulation (ROSC).
The study was conducted using RhinoChill(TM), a non-invasive nasal catheter that sprays a rapidly evaporating coolant liquid into the nasal cavity. This large cavity is a heat exchanger and lies right under the brain.
The trial was designed to determine the safety and effectiveness of early cooling initiated at the site of the arrest. The RhinoChill(TM) technology enabled cooling to start much earlier than is possible with conventional methods used in a hospital setting and focuses on the brain. "The brain is the organ that dies first so the closer to the time of arrest the brain is cooled, the more of it is rescued," said Denise Barbut, M.D, founder and CEO of BeneChill, the company that makes RhinoChill. "The brain is the organ that controls the heart, much like a puppet on a string," she added.
Additional endpoints included cooling rates, time to achieve target temperature, ease of use in the field, ROSC rates, survival and neurologically intact survival. EMS personnel recruited adults over 18 years old who were in cardiac arrest and not hospitalized during resuscitation. All patients who were deemed eligible for advance cardiac life support (ACLS) were included as long as the arrest was witnessed and cardiopulmonary resuscitation (CPR) was initiated within 20 minutes of collapse.
The results of the study included: