Frequently Asked Questions

Administration of a neuromuscular blockade in the pre-hospital setting should not be required. Patients should tolerate at least an hour of RhinoChill System cooling before anti-shivering measures are needed. If patients are conscious, then conscious sedation should be administered using either pethidine or propofol to lower the shivering threshold and minimize discomfort.

The RhinoChill System Coolant is completely inert and is immiscible with water. It is also 70% heavier than water and it will therefore rapidly pass through the digestive system. Loose stools may be observed.

Supplemental oxygen should be delivered if the patient aspirates the coolant. Increasing ventilation breath rate and positive end expiratory pressure (PEEP) will facilitate the evaporation and expiration of vaporized coolant. The duration of treatment should be determined by blood gas values.

If 100% oxygen is used with the RhinoChill System there may be no detectable effect. However, if the patient has any compromised respiratory function (e.g., COPD or emphysema) they may undergo arterial desaturation due to less than adequate oxygen being available for respiration. If air is used with the RhinoChill System, the available oxygen content could be as low as 11%. This concentration would be likely to cause an arterial desaturation and would require supplemental oxygen to be delivered if the airway was not protected. 

Vaporized coolant can reduce the oxygen content of inspired gas in the patient. The vapor pressure of evaporated coolant is 0.48 bar (363mmHg) at 37°C; it can therefore displace up to 48% of the available oxygen in the airway if it is aspirated. Hence, 100% oxygen delivery is reduced to 52% oxygen available for alveolar respiration. Airway protection ensures that the fraction of oxygen delivered is the fraction of oxygen available for respiration. Moreover, when the airway is protected, the coolant vapor is kept in the nasal cavity to facilitate brain cooling.

If the patient’s nose turns white while cooling during ACLS, no action should be taken. If the patient achieves ROSC, the discoloration will resolve with return of peripheral circulation. Vasodilatory agents may hasten the resolution. If the patient’s nose turns white while cooling in the post-ROSC phase, then the flow rate is likely too high and the coolant is not fully evaporating within the nasal cavity. The flow rate can either be turned down, or the RhinoChill System can be turned off. After the discoloration has resolved, the flow can be resumed if it was turned off. If liquid coolant is ever seen splattering on the outside of the nose, then the flow is likely turned too high.

Risks associated with the use of the RhinoChill System include those related to the use of the device as well as those related to systemic hypothermia. Therefore, contraindications to cooling (e.g., cold-related pathologies or non-induced coagulopathy) should be adhered to when considering use of the RhinoChill System. Similarly, prophylaxes to common side effects of cooling should also be considered.

The RhinoChill System has been used in 213 patients in sponsored clinical studies. The most common side effects are the following:

• Discoloration of the nasal tissue ?10%
• Epsitaxis ? 5%

• Peri-orbital emphysema ? 1%

Side effects were typically of short duration and resolved spontaneously. Nasal tissue discoloration is more likely to occur in patients with poor peripheral circulation (cardiogenic shock) or no spontaneous flow (cardiac arrest). Peri-orbital emphysema was observed in patients with a history of chronic sinusitis.

The coolant is highly volatile and has a low surface tension. When the liquid coolant is mixed with the gas propellant, it is nebulized within the nasal cavity. The low surface tension enables the nebulized liquid to spread throughout the entire volume of the nasal cavity. The nasal cavity is designed to warm inspired air to body temperature for respiration, and this mechanism evaporates the volatile liquid. Phase change of the coolant from a liquid to a gas removes 35 calories of heat per every ml of liquid coolant. Heat is removed directly from the area surround the nasal cavity via conduction. The nasal cavity is extremely well vascularized - which facilitates the warming mechanism, and therefore both the venous and arterial blood is cooled via convection. The brain is cooled preferentially by both mechanisms, and systemic cooling is achieved by convective hematagenic cooling. In the absence of circulation, the brain is cooled via direct conduction.

The RhinoChill^TM IntraNasal Cooling System is classified as IIb under the European Medical Device Directive.

Contraindications to hypothermia (Raynaud’s disease, Cryoglobulinemia, Sickle Cell disease), specific temperature- sensitive pathologies (e.g., serum cold agglutinins, Buerger’s disease), have bleeding disorders (e.g., hemophilia) require oxygen supplied at >50% FiO2 to maintain normal saturation (>94%), have an intranasal obstruction or known skull base fracture.

The 2008 ILCOR consensus statement regarding post-cardiac arrest care states that cooling should begin “as soon as possible” after cardiac arrest. The 2010 ERC & AHA guidelines continue to support this recommendation. The recommendation language has been updated to reflect numerous animal studies that indicate cooling prior to the return of spontaneous circulation helps reduce the neurological damage associated with reperfusion. Cooling with the RhinoChill System should therefore be initiated as soon as possible during ongoing CPR after the patient’s airway is protected (LMA, or laryngeal tube will suffice).

The Medium flow setting (40 L/min) is considered the nominal flow rate. The Low flow setting (20 L/min) should be used only after the patient has cooled to therapeutic temperatures and can be used to augment cooling while transitioning to standard cooling methods. The High flow setting (60 L/min) should be used only when there is an adequate gas supply and expedited cooling is desired.
Flow rates of 0.25 L/min/kg body weight (equivalent to 20 L/min) did not improve ROSC rates in a porcine model of prolonged VF, but flow rates of 0.5 L/min/kg (equivalent to 40 L/min) did. It is therefore recommended that flow rates of at least 40 L/min be used if cooling is begun prior to the patient achieving ROSC.

Cooling with the RhinoChill System should continue until standard cooling methods have been implemented in the hospital setting. Additional supplemental cooling should be considered when the systemic cooling method employs a surface cooling device, because surface cooling devices redistribute warm blood from the periphery to the brain and heart that have been cooled by the RhinoChill System.

No.

Patient temperature should be monitored intermittently in the pre-hospital setting. Tympanic or esophageal thermometers are appropriate for use; a nasopharyngeal one is not.
The RhinoChill System cools the brain preferentially over the body, and the brain cannot be over-cooled. Temperature monitoring is used with other cooling systems to ensure the core temperature does not get too cold, as it is core temperature reduction that causes problems in cooling – not brain temperature reduction.
35 calories of heat are removed from the body for every ml of coolant that evaporates. Therefore, the approximate whole- body temperature reduction that a 1L bottle of coolant could achieve in a 70kg patient is 0.85°C.

The patient will begin to shiver only after the core temperature is significantly reduced. The patient would not be expected to begin shivering until after hospital admission unless a very long hospital transport time is required.

The patient’s mouth and nose should not be covered when the RhinoChill System is being used in order for the evaporated coolant to escape. Therefore, personal protective measures should be taken to prevent cross-contamination.

It is technically possible to maintain target temperature with the RhinoChill System, but it is not recommended. The RhinoChill System has no temperature feedback control mechanism by which to control the amount of cooling that is delivered. It would therefore require intensive nursing efforts to turn the system off and on to maintain the target temperature in the narrow therapeutic range.

The RhinoChillTM Starter Set consists of one tubing set and one coolant bottle. This is the minimum amount required for each patient. Additional coolant bottles can be purchased in a 2-pack.

The RhinoChill System Coolant bottle should be used in one patient only. Using a single coolant bottle on more than one patient introduces the risk of cross contamination. Partially full coolant bottles should be incinerated by a licensed waste disposal organization at a site equipped with an after-burner and scrubber. Small quantities can be disposed in waste that is sent to an authorized landfill site. The RhinoChill System Coolant should not be discharged into drains. It is important to observe all national and regional regulations concerning waste disposal.

You should report issues concerning the operation of the RhinoChill System directly to BeneChill International at: +41 21 566 52 70 or by contacting BeneChill through the website at www.benechill.com.

You should contact BeneChill International directly or the authorized sales representative in your country with any questions you may have regarding the RhinoChill System.

There are a number of physicians and emergency medical personnel that have used the RhinoChill System in sponsored clinical trials. BeneChill International will provide you with the contact information of someone you may speak to based on your geography.

The tubing set should be placed so that the nasal catheters are fully inserted. The nostril valves will hold the tubing set in place if the patient is not moved. The tubing set has a retention strap attached to the catheter hub that can be secured around the patient’s head for moving them.

The nasal catheters are made of a medical-grade of urethane. The delivery tubing is made of polyvinyl chloride (PVC) but is free of the component material (DEHP) that has been linked to safety hazards. The additional hard molded parts (catheter hub, control unit connector) are also PVC (free of DEHP). The tubing set is entirely latex-free.

No. Using the tubing set in more than one patient will introduce the risk for cross-contamination.

The RhinoChill System can be configured for both pre-hospital and in-hospital use by choosing appropriate add-on kits and accessories. Pre-hospital kits/accessories include a gas cylinder holder, adapter, shoulder strap, and storage bags. In- hospital use should involve connecting the RhinoChill System directly to the hospital supply gas. It can be mounted to either an IV pole or hung on the bedside rail.

The docking station provides a secure fixation in the ambulance. Each site will need to determine the best method of fixation in the emergency vehicle. The shoulder strap and bedrail hooks provide flexible options for mobile fixation, during the transport from the ambulance to the receiving hospital department. This is not an alternative for the fixation in the docking station during patient transport in the ambulance.

The RhinoChill System will not be certified for helicopter use upon initial commercial distribution. Sites may submit the RhinoChill System to local testing for helicopter certification if desired. (Local certifications were obtained by some sites in the PRINCE Clinical study.)

The RhinoChill System has a 5-year service life. Preventive maintenance should be performed on an annual basis to ensure optimal operation. BeneChill will provide this preventive maintenance service.

The coolant is a proprietary liquid chemical that is completely inert and evaporates very easily.

No.

Intranasal temperatures measured in a clinical study varied between -5 to 5°C for sedated patients with spontaneous circulation. It is conceivable that colder temperatures are achieved in patients with no circulation (i.e., in cardiac arrest).

The pour point – or the lowest point at which the coolant will still flow as a liquid - is -90°C. It will freeze at a temperature below this.

No. The chemical in the coolant has been investigated by the US Environmental Protection Agency and is considered to have no impact. Moreover, the chemical is not a CFC and has no effect on the ozone layer.

The RhinoChill System Coolant is available in 1 liter bottles.

The RhinoChill System delivers 0.8ml coolant with every 1L of gas. The flow setting also determines the duration the coolant will last:

The spray pressure is also dependent on the flow setting:

Pressurized gas “powers” the cooling. An internal rechargeable battery powers the electronics. An external power supply is required to recharge the RhinoChill System battery. An external power source of 12 Volts DC, either from vehicle power or the supplied AC power adaptor, can also be used to run the RhinoChill System.

The battery will last 4 hours under nominal use conditions. The actual time depends upon the conditions in which the RhinoChill is used: the battery may last longer than 6 hours if used under temperate conditions, but it may be reduced to as low as 2 hours if the RhinoChill is operated in an environment below 15°C.

The specification is that a ‘dead’ battery should be fully charged in less than 10 hours. However, this is likely to be 4 hours or less if the RhinoChill System is charged at room temperature. Note however, the RhinoChill System will always run – and recharge - when it is plugged into an external power source, even when the battery is completely discharged (similar to a laptop computer).

BeneChill offers a Docking Station for purchase that will allow the RhinoChill System to be docked in the vehicle and integrated with the vehicle electrical power.

TheRhinoChillSystemwilloperatewitheitherpureoxygenorair,oranyenhancedoxygen-airmix. Thegasshouldbe supplied to the RhinoChill System at a regulated pressure ranging between 3.1-4.8bar.

It depends on the gas flow and size of the tank.