Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Conditions
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Coma, Heart Arrest

Intervention / Treatment
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* Device: ThermoSuit(R) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC). Cardiac arrest of presumed cardiac origin. Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole. Estimated or known age > 18 years. Intubation, ventilation and placement of esophageal probe. Estimated time from collapse to the initiation of Advanced Cardiac Life Support (ACLS) < 15 minutes and return of spontaneous circulation with defibrillation within 60 minutes of collapse. Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS ≤ 8]. Exclusion Criteria: Height greater than 188 cm. Elbow-to-elbow width greater than 60 cm (as measured above the supine patient). Core temperature less than 34°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space, nasopharynx, or central blood vessel). Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system. Known pregnancy. Response to verbal commands after ROSC (but before enrollment). Known terminal illness that preceded the arrest. Known enrollment in another study of a device, drug, or biologic. Major trauma or other co-morbidity requiring urgent surgery. Improving neurologic status. > 8 hours since return of spontaneous circulation. Unknown time of arrest. Severe or known coagulopathy (with active bleeding). Hemodynamic instability despite vasopressors (SBP < 90 mmHg or MAP < 60 mmHg for > 30 minutes after ROSC and before enrollment).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ThermoSuit(R) System|The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resuscitation, hypothermia