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

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.

Study Overview

• Status: Completed
• Conditions: Heart Arrest; Coma
• Intervention / Treatment: Device: ThermoSuit(R) System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Neurologic and physical status at 6 month ± 15 days follow-up.	6 months ± 15 days after hospital discharge
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

Collaborators and Investigators

• Sponsor: Life Recovery Systems
• Collaborators: Unity Health Toronto; Queen's University
• Investigators: Principal Investigator: Dorian Paul, MD, St. Michael's Hospital, University of Toronto; Principal Investigator: Daniel Howes, M.D., Queen's University

Publications and helpful links

Helpful Links

• Website for Life Recovery Systems

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: December 12, 2006
• First Submitted That Met QC Criteria: December 12, 2006
• First Posted (Estimate): December 13, 2006

Study Record Updates

• Last Update Posted (Estimate): September 29, 2008
• Last Update Submitted That Met QC Criteria: September 25, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: hypothermia; resuscitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: LRS-01-05-02