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

This study has been completed.
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by:
Life Recovery Systems
ClinicalTrials.gov Identifier:
NCT00384319
First received: October 4, 2006
Last updated: January 3, 2008
Last verified: December 2007
  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
Cardiac Arrest
Comatose
Device: ThermoSuit(R) System
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Resource links provided by NLM:


Further study details as provided by Life Recovery Systems:

Primary Outcome Measures:
  • Primary: 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 12 hours (whether or not supplemental cooling is needed) [ Time Frame: First 12 hours after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary: Total number of days in ICU; [ Time Frame: Time while 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 while patient is hospitalized ] [ Designated as safety issue: Yes ]
  • Neurologic and physical status at discharge; [ Time Frame: Time at which patient is discharged for 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 ]
  • 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 ]

Enrollment: 10
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ThermoSuit(R) System
    The ThermoSuit device 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).
  • 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.
  • 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 35°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.
  • > 4 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384319

Locations
Austria
General Hospital, University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Life Recovery Systems
Medical University of Vienna
Investigators
Principal Investigator: Michael Holzer, MD General Hospital, University of Vienna
  More Information

No publications provided

Responsible Party: Robert Schock/Vice President Research and Development, Life Recovery Systems
ClinicalTrials.gov Identifier: NCT00384319     History of Changes
Other Study ID Numbers: LRS-01-06-01
Study First Received: October 4, 2006
Last Updated: January 3, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Life Recovery Systems:
resuscitation
hypothermia

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014