Review the Indications for Use.

Guidelines

American Heart Association Guidelines

In November 2005, the American Heart Association released updated recommendations regarding the use of therapeutic hypothermia, stating that...

"Although the number of patients who may benefit from hypothermia induction is limited at present, it is possible that with more rapid and controlled cooling and better insights into optimal target temperature, timing, duration, and mechanism of action, such cooling may prove more widely beneficial in the future."

AHA's most recent treatment guidelines include the following recommendations:

• Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF). Level of evidence IIa.
• Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest. Level of evidence IIb.

*Circulation 2005:IV-84-IV-88 

Current Treatment Options

AHA's ILCOR's advisory committee's statement in support of therapeutic hypothermia notes the following:

*Circulation 2003:108:118-121 

Life Recovery Systems will address the unmet need for an easy-to-use, highly effective approach to the delivery of therapeutic hypothermia.

FDA Cleared Indications for Use

The ThermoSuit is a thermal regulating system

Indications for use are:

a. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients;

b. Monitoring of patient temperature.

Patient Population

The ThermoSuit System (Size M) is indicated for patients

• Greater than 58”(147 cm) and less than 75” (190 cm) in height
• And less than 26” (66 cm) in width

References

ThermoSuit^® Related References (link to pdf)

Randomized Animal Study File	Vienna Study File

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