Fair Balance Disclosure
Risks associated with the use of the RhinoChill™ IntraNasal Cooling System include those related to the use of the device as well as those related to systemic hypothermia. The following device or procedure-related adverse events were reported in the 213 patients in whom the RhinoChill has been used:
Serious adverse events:
- Cold-related tissue damage: n=1 (0.47%). The subject was in irreversible cardiogenic shock when enrolled and cooled with the RhinoChill. Tissue discoloration appeared approximately 2 hours after RhinoChill cooling was halted following an 80-minute cooling period. The subject died due to persistent cardiogenic shock approximately 36 hours after RhinoChill use without resolution of tissue discoloration.
- Epistaxis: n=1 (0.47%). The subject was enrolled under emergency conditions during resuscitation from cardiac arrest with an undiagnosed coagulopathy. Bleeding began 16 minutes after RhinoChill cooling was started. Cooling was halted, and resuscitation efforts persisted for 8 more minutes. The subject did not regain spontaneous circulation despite 40 minutes of basic and advanced cardiac life support efforts. It was learned that the subject was in late stage hepatic failure at the time of cardiac arrest.
- Hypertension: n=1 (0.47%). The subject presented unconscious with no apparent need for additional sedation. Mean arterial pressure rose from 75 to 94 within the first 15 minutes of RhinoChill cooling. An oral anti-hypertensive was administered. No reduction in pressure was observed over the subsequent 15-minute period of RhinoChill cooling. Cooling was then halted, an intravenous line was placed, and the patient was sedated; mean arterial pressure normalized within 30 minutes.
- Hypoxia: n=1 (0.47%). A loss of airway protection was noted during RhinoChill cooling with a ventilation setting of 50% inspired oxygen when the pulse oximetry reading fell to 94%. Airway protection was re-established and cooling was halted per protocol 15 minutes later. Arterial oxygen saturation fell to 85% over the ensuing 2-hour period. Inspired oxygen was then increased to 100% and positive end-expiratory pressure was increased. Arterial oxygen saturation rose from 85 to 97% over the subsequent 30 minutes. Arterial saturation was maintained at 98% on 50% oxygen within 2 hours.
Non-serious adverse events:
- Discoloration of the nasal tissue ≈ 10%
- Epsitaxis ≈ 5%
- Peri-orbital emphysema ≈ 1%
Additional potential risks exist that have not been attributed to the use of the RhinoChill in past patient series. These include the following:
- Acute myocardial infarction
- Barotrauma to the nasal cavity/nasopharynx
- Cardiac rhythm disturbances including ventricular fibrillation
- Emphysema, pulmonary
- Hemorrhage (not epistaxis)
- Pulmonary embolism