Status:
COMPLETED
Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients
Lead Sponsor:
Life Recovery Systems
Collaborating Sponsors:
Unity Health Toronto
Kingston Health Sciences Centre
Conditions:
Heart Arrest
Coma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00410969
Start Date
December 1 2006
End Date
September 1 2008
Last Update
September 29 2008
Active Locations (2)
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1
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8