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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| Kingston Health Sciences Centre | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThermoSuit(R) System | Device | The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from collapse to achieving desired range of cooling (32.0 to 34.0°C) | Day of treatment | |
| Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C | 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. | 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. | First day after treatment | |
| Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7) | Day of treatment | |
| Duration of maintenance of hypothermia without supplemental cooling | First day after treatment | |
| Ease of maintenance of hypothermia for 24 hours (whether or not supplemental cooling is needed) | First day after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of days in ICU | Time that patient is in ICU | |
| Barriers to compliance | First day after treatment | |
| Neurologic and physical status during in-hospital recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorian Paul, MD | St. Michael's Hospital, University of Toronto | Principal Investigator |
| Daniel Howes, M.D. | Kingston Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada | ||
| St. Michael's Hospital |
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| Label | URL |
|---|---|
| Website for Life Recovery Systems | View source |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D003128 | Coma |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Time that patient is in hospital |
| Neurologic and physical status at discharge | Time that patient is discharged from hospital |
| Neurologic and physical status at 30 ± 7 days follow-up for surviving patients | 30 ± 7 days after hospital discharge |
| Incidence of shivering during cooling and maintenance of hypothermia | First day after treatment |
| Requirements for use of paralysis to control shivering | First day after treatment |
| Neurologic and physical status at 6 month ± 15 days follow-up. | 6 months ± 15 days after hospital discharge |
| Toronto |
| Ontario |
| M5B 1W8 |
| Canada |
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |