BeneChill’s clinical approach has focused first on the use of the RhinoChill in cardiac arrest as the clinical evidence for cooling during cardiac arrest outweighs the clinical evidence for cooling after stroke or traumatic brain injury (TBI). Further programs are undertaking small safety and performance studies in stroke with plans to perform a larger randomized stroke study in the future. Similarly, BeneChill’s clinical program will likely perform small safety/feasibility studies in TBI in the future.
On-going, physician-sponsored studies include the PRINCESS cardiac arrest study and a small stroke study. The aim of the PRINCESS study is to initiate cooling much earlier during the arrest in an attempt to improve outcomes further. The purpose of the the small stroke study, which is being conducted in Heidelberg, Germany, is to compare ease-of-use, cooling efficacy and hemodynamics using different cooling techniques.
Animal studies suggest a life-saving benefit for intra-arrest cooling. No human studies to date have demonstrated an effective, practical method. Trans-nasal evaporative cooling has sufficient heat transfer capacity for effective intra-arrest cooling and improves survival in swine.
To study the safety and feasibility of trans-nasal cooling in the pre-hospital setting and determine effects on neurologically intact survival to hospital discharge from the addition of intra-arrest transnasal cooling compared to hospital-based cooling alone.
200 patients in witnessed cardiac arrest with CPR ≤20 minutes were randomized to intra-arrest trans-nasal cooling (treatment) versus standard ACLS care (control) in 15 European EMS systems. Trans-nasal cooling (RhinoChill®, BeneChill Inc. San Diego, CA) was initiated using a mixture of volatile coolant plus oxygen for rapid evaporative heat transfer. In treatment patients, cooling was initiated as soon as feasible without interfering with ACLS protocols, during ongoing CPR. Patients in both groups were cooled upon hospital arrival.
Intra-arrest trans-nasal cooling is safe and feasible in the pre-hospital setting and significantly lowers tympanic and core temperature upon arrival at hospital. Survival to discharge and neurologically intact survival is significantly improved in witnessed arrests where CPR is initiated ≤10 minutes of collapse.
View the abstract from this study.
Download a PDF of the Prince Clinical Sheet
BeneChill conducted a single-arm safety and feasibility study of early cooling with the RhinoChill® IntraNasal Cooling System in patients resuscitated from cardiac arrest.
The RhinoChill® IntraNasal Cooling System was used to cool patients as soon as it was feasible and cooling was continued until target temperature was reached or when standard systemic cooling methods were ready to be initiated.
BeneChill conducted a single-arm safety and feasibility study of cooling induction with the RhinoChill® IntraNasal Cooling System in patients requiring therapeutic cooling after experiencing a cerebral ischemic event.
The RhinoChill® IntraNasal Cooling System was used to cool patients for one hour to induce cooling while systemic cooling methods were being readied for use.
Janata; Nasal Cooling with a New Cooling Device in Patients after CardiacArrest and Successful Resuscitation, European Resuscitation Council (ERC) Congress, Oral abstract, May 2008
Foedisch; Rapid Induction of Therapeutic Hypothermia after Cardiac Arrestwith Intranasal Cooling– A Preliminary Report, European Society of Intensive Care Medicine Congress (ESICM), Poster, Sep 2008
Busch; Pre-Treatment with Trans-Nasal Cooling for The Induction ofTherapeutic Hypothermia in Patients with Cardiac Arrest Leads to a Significant Faster Achievement of Target Temperature During Systemic Cooling , ESICM, Poster, Sep 2008
Sung; RhinoChill: A Novel Hypothermia Delivery System NICU, World Stroke Organization Congress, Poster, Sep 2008
Busch; Safety and feasibility of a new innovative cooling approach for immediate induction of therapeutic hypothermia in patients after successful resuscitation, American Heart Association (AHA),(Resuscitation Science Symposium (ReSS)), Poster, Nov 2008
Busch; Rapid electrical and hemodynamic stabilization during cardiac arrest via trans-nasal cooling in a patient with prehospital cardiac arrest: A case report CA pre-ROSC, Society of Critical Care Medicine (SCCM), Poster, Feb 2009
Taccone; Nasopharyngeal cooling during resuscitation: Randomized study Cardiac Arrest Trial – preliminary, International Symposium on Intensive Care and Emergency Medicine (ISICEM), Poster, Mar 2009
Nordberg; New method of intra-arrest trans-nasal cooling in Stockholm – The PRINCE II study Stockholm, International Hypothermia Symposium, Sep 2009
Castren; Intra-arrest transnasal cooling: A randomized prehospital study: PRINCE (Pre-ROSC Intra Nasal Cooling Effectiveness), AHA (ReSS), Oral abstract, Nov 2009 View PowerPoint Presentation
Taccone; Trans-nasal cooling during CPR: A single-center experience PRINCE – Erasme Experience, ISICEM, Poster, Mar 2010
Busch; Intra-arrest cooling using a novel intra-nasal cooling method for immediate induction of therapeutic hypothermia in Germany , ISICEM, Poster, Mar 2010
Glencorse; A review of the pre-ROSC intranasal cooling effectiveness study, Journal of Paramedic Practice ,Vol 3 No 6 297, March 2011
Fritz; Hypothermiebehandlung: Die transnasale Kühlung, PflegenIntensiv, Mar 2009
Busch; Safety and feasibility of nasopharyngeal evaporative cooling in the emergency department setting in survivors of cardiac arrest 84 cardiac arrest patients.,Resuscitation 2010;81:943-9 Aug 2010
Castrén; Intra-arrest trans-nasal evaporative cooling: A randomized prehospital multi-center study: PRINCE (Pre-ROSC Intra Nasal Cooling Effectiveness) 200 patients, Circulation 2010;122:729-36. Aug 2010
What the scientific community is saying about RhinoChill (editorials).