Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients - Full Text View

Sponsors and Collaborators:	Life Recovery Systems St. Michael's Hospital, Toronto Kingston General Hospital
Information provided by:	Life Recovery Systems
ClinicalTrials.gov Identifier:	NCT00410969

Purpose

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.

Condition	Intervention	Phase
Heart Arrest Coma	Device: ThermoSuit(R) System	Phase I

MedlinePlus related topics: Hypothermia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Further study details as provided by Life Recovery Systems:

Primary Outcome Measures:

Time from collapse to achieving desired range of cooling (32.0 to 34.0°C) [ Time Frame: Day of treatment ] [ Designated as safety issue: No ]
Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C [ Time Frame: Day of treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7) [ Time Frame: Day of treatment ] [ Designated as safety issue: No ]
Duration of maintenance of hypothermia without supplemental cooling [ Time Frame: First day after treatment ] [ Designated as safety issue: No ]
Ease of maintenance of hypothermia for 24 hours (whether or not supplemental cooling is needed) [ Time Frame: First day after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total number of days in ICU [ Time Frame: Time that patient is in ICU ] [ Designated as safety issue: No ]
Barriers to compliance [ Time Frame: First day after treatment ] [ Designated as safety issue: No ]
Neurologic and physical status during in-hospital recovery [ Time Frame: Time that patient is in hospital ] [ Designated as safety issue: Yes ]
Neurologic and physical status at discharge [ Time Frame: Time that patient is discharged from hospital ] [ Designated as safety issue: Yes ]
Neurologic and physical status at 30 ± 7 days follow-up for surviving patients [ Time Frame: 30 ± 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
Incidence of shivering during cooling and maintenance of hypothermia [ Time Frame: First day after treatment ] [ Designated as safety issue: No ]
Requirements for use of paralysis to control shivering [ Time Frame: First day after treatment ] [ Designated as safety issue: No ]
Neurologic and physical status at 6 month ± 15 days follow-up. [ Time Frame: 6 months ± 15 days after hospital discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	27
Study Start Date:	December 2006
Study Completion Date:	September 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Intervention Details:

The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water.

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. 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410969

Locations

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7

Sponsors and Collaborators

Life Recovery Systems

St. Michael's Hospital, Toronto

Kingston General Hospital

Investigators

Principal Investigator:	Dorian Paul, MD	St. Michael's Hospital, University of Toronto
Principal Investigator:	Daniel Howes, M.D.	Kingston General Hospital

More Information

Website for Life Recovery Systems This link exits the ClinicalTrials.gov site

Responsible Party:	Livfe Recovery Systems ( Robert Schock/Vice President, Research and Development )
Study ID Numbers:	LRS-01-05-02
Study First Received:	December 12, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00410969
Health Authority:	Canada: Health Canada

Keywords provided by Life Recovery Systems:

resuscitation
hypothermia

Study placed in the following topic categories:

Coma
Hypothermia
Heart Diseases
Heart Arrest

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009