Neuro ICU Study
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.