Clinical evidence

Introduction

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.

Aim

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.

Method

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.

Conclusions

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

RhinoChill® Intra Nasal Cooling System ER Cooling Study

BeneChill conducted a single-arm safety and feasibility study of early cooling with the RhinoChill® IntraNasal Cooling System in patients resuscitated from cardiac arrest.

• Eighty-four patients were treated at 11 sites in Europe from September 2007 through August 2008.
• Patients were enrolled in the study as soon as they were admitted to the hospital facility treating cardiac arrest in the emergency room (ER), cardiac catheterization lab, or intensive care unit (ICU) and found to meet study inclusion criteria.
• Thirty-three percent of patients experienced an in-hospital cardiac arrest and the remaining 67% were admitted following an out of hospital 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.

• The RhinoChill® IntraNasal Cooling System was used to begin cooling 35 minutes (median value) after patients were admitted to the hospital. A cooling gradient between temperatures observed with relative cooling rates of 2.4, 1.6, and 0.9°C/hr measured in the tympanon, esophagus or peripheral artery and bladder or rectum, respectively.
• A therapeutic temperature of 34°C was reached within 27 and 51 minutes of use for the tympanon and whole body, respectively.
• There was a single serious device-related event in which a patient in irreversible cardiogenic shock underwent cold-related tissue damage to the peri-nasal region.

RhinoChill^® IntraNasal Cooling System Neuro & ICU Cooling Study

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.

• Fifteen patients were treated at three sites in the US from November 2007 through February 2009.
• Patients were enrolled in the study after admission to the Neuro-ICU and therapeutic cooling was ordered to treat either elevated intra-cranial pressure or neurogenic fever.
• Eight (53%) patients underwent hemorrhagic stroke or other cerebral hemorrhagic event, six patients experienced a large ischemic stroke and one patient had traumatic brain injury

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.

• A cooling gradient between temperatures observed with relative cooling rates of 2.2, 1.5, and 1.1°C/hr measured in the tympanon, brain or core (primarily bladder), respectively.
• The initial average intracranial pressure was 16mmHg and dropped an average of 5.2mmHg, or 32.5% over the hour of RhinoChill® cooling. Brain cooling was as effective in febrile patients as it was afebrile.
• Additionally, brain cooling was effective in two morbidly obese patients that underwent very little systemic cooling due to their large body mass.
• There was a single serious device/procedure-related event in which a comatose patient underwent an increase in mean arterial pressure from 75 to 94mmHg within the first 15 minutes of RhinoChill® cooling which was sustained for an additional 15 minutes. Pressure normalized after cooling was stopped and sedation was administered.

Abstracts

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

Manuscripts

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).

• Tisherman; Can an ice cream headache save your life?, Crit Care Med 2010; 38:1006-7 Mar 2010
• Becker; Cooling heads and hearts versus cooling our heels., Circulation 2010;122:679-81, Aug 2010