BeneChill is committed to the thorough investigation of the effects of intra-nasal cooling with the RhinoChill® IntraNasal Cooling System through its comprehensive clinical program.
Extensive Pre-Clinical Studies
A rigorous pre-clinical program has been carried out to identify potential benefits of the RhinoChill® IntraNasal Cooling System in animal models.
Clinical Program Investigates Pre-Hospital and Hospital Use of RhinoChill® System
Two initial clinical investigations were conducted in both cardiac arrest and cerebral ischemia patients. The ER Cooling Study investigated the safety and feasibility of early cooling in cardiac arrest patients once admitted to the hospital. The Neuro & ICU Study investigated the safety and feasibility of the RhinoChill System in patients suffering from a cerebral ischemic event.
First Randomized Intra-Arrest Study of Therapeutic Hypothermia
In 2009 the company completed the first randomized intra-arrest study of therapeutic hypothermia. The PRINCE (Pre-ROSC Intra-Nasal Cooling Effectiveness) Study investigated the safety and feasibility of trans-nasal cooling in the pre-hospital setting and determined effects on neurologically intact survival to hospital discharge from the addition of intra-arrest trans-nasal cooling compared to hospital-based cooling alone. The study demonstrated that intra-arrest trans-nasal cooling is safe and feasible in the pre-hospital setting and significantly lowers tympanic and core temperature upon arrival at the hospital. Survival to discharge and neurologically intact survival is significantly improved in witnessed cardiac arrests where CPR is initiated within 10 minutes of collapse. Results of this study were published in Circulation .