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.