The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.
The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The ThermoSuit device is used to cool patients using direct contact of the skin with cold water.
General Hospital, University of Vienna
Vienna, Austria
Primary: Time from collapse to achieving desired range of cooling (32.0 to 34.0°C);
Time frame: Day of treatment
Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C;
Time frame: Day of treatment
Total time during the first 24 hours after cooling is initiated that the core temperature is between 32.0 and 34.0°C.;
Time frame: First day after treatment
Protocol compliance: This is defined as the proportion of patients in whom compliance (i.e. target temperature range) is achieved 85% of the time.;
Time frame: First day after treatment
Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7);
Time frame: Day of treatment
Duration of maintenance of hypothermia without supplemental cooling;
Time frame: First day after treatment
Ease of maintenance of hypothermia for 12 hours (whether or not supplemental cooling is needed)
Time frame: First 12 hours after treatment
Secondary: Total number of days in ICU;
Time frame: Time while patient is in ICU
Barriers to compliance;
Time frame: First day after treatment
Neurologic and physical status during in-hospital recovery;
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Time frame: Time while patient is hospitalized
Neurologic and physical status at discharge;
Time frame: Time at which patient is discharged for hospital
Neurologic and physical status at 30 ± 7 days follow-up for surviving patients;
Time frame: 30 ± 7 days after hospital discharge
Neurologic and physical status at 6 month ± 15 days follow-up.
Time frame: 6 months ± 15 days after hospital discharge