Arctic Sun Medical Device - Device Description

Device Description

The Arctic Sun has been explained as dry water immersion. It is a non-invasive precision temperature management system that is often used to induce hypothermia in comatose patients that have suffered from Sudden Cardiac Arrest (SCA) and patients at risk for ischemic brain damage. The unique thing about the Arctic Sun is the gel pads, which stick to a patient’s body using an adhesive called hydrogel—a substance that adheres to the skin without removing hair follicles. The gel pads cover only a portion of a patient’s body and subsequently leave most of the body free for augmenting medical procedures. The device operates under negative pressure and circulates water through these pads at a temperature between 4–42 °C (39–108 °F). Water is pulled through the pads, which minimizes the risk of leakage. By controlling the temperature of the water running through the gel pads, the Arctic Sun’s adjusts a patient’s temperature. Arctic Sun can also rewarm patients. Controlled rewarming has been cited in the literature as beneficial in preventing reperfusion injury. Because of the Arctic Sun’s noninvasive nature, treatment can be delivered without the host of adverse events associated with invasive procedures such as cooling catheters.

A fomer complaint levied against the Arctic Sun relates to the risk of skin injury. a study published in 2007 found that the Arctic Sun was, "highly effective in lowering patients’ temperature rapidly without inducing skin irritations.". Further, when comparing MDR's registed by Medivance vs the cooling catheters and conventional cooling blankets and wraps, one will find far fewere incidence of patient injury.

Invasive cooling catheter companies have claimed that catheters can lower body temperature at a faster rate, which is relevant because most of the clinical data suggests that the sooner cooling initiates the better a patient’s outcome. However, there exists a 75 minute delay on average between admittance and catheter insertion. Even with a physician readily available to place the cooling catheter, the operating instructions underline the importance of the device set up with takes a minimum of 25 minutes. When objectively evaluating the published data the average cooling rate for cooling catheters is 1.12°C. Treatment with the Arctic Sun can be administered within 10 minutes by unsupervised nursing professionals.

Historically, clinicians reported that catheters cool at a quicker rate, however, a 2011 study published in the Society of Critical Care Medicine where 167 patients treated either with the Arctic Sun or the Alsius Coolgard Cather showed the following:

There was no significant difference in survival with good neurologic function, either to hospital discharge or at follow-up. Time from cardiac arrest to achieving mild therapeutic hypothermia was equal with both devices (surface, 273 min, core, 270 min).”

• Cooling was initiated immediately in the emergency department on hospital arrival with ice packs around groin, armpits and neck and infusion of up to 3 L of refrigerated saline
• All patients were “deeply sedated”
• No device-specific patient injuries were observed; skin injuries with the Arctic Sun or DVT with Coolgard
• No differences in shivering: “
• Article quote: ”Skin temperature is known to influence thermoregulatory control, and it previously has been speculated that core cooling could result in less shivering.

However, this could not be confirmed in the present study, because there was no difference in the rate of shivering in surface-cooled or core-cooled patients.”

• No differences were observed in Lengths of ICU stay, durations of respirator dependency, rates of MTH discontinuation, and post cooling

Conclusions: “Surface and core cooling of out-of hospital cardiac arrest patients following the same established postresuscitation treatment protocol resulted in similar survival to hospital discharge and comparable neurologic function at follow-up.”

Crit Care Med Vol 39 No 3

In a case attracting much media attention in May 2008, the Arctic Sun was used to induce hypothermia in a 59 year old woman in West Virginia who had suffered 3 cardiac arrests within a 24 hour period. For more than 17 hours the woman had no measurable brain waves, according to her doctors, and her heart had been stopped for a prolonged period of time. The family decided to take her off life support. Shortly after being disconnected from the ventilator, the woman surprisingly recovered, regaining consciousness, motor function, and speech.