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

NCT ID: NCT00384319

Last Updated: 2008-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-12-31

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. 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.

Conditions

Cardiac Arrest; Comatose

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ThermoSuit(R) System

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

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

Life Recovery Systems

OTHER

Sponsor Role: lead

Responsible Party

Life Recovery Systems

Principal Investigators

Michael Holzer, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital, University of Vienna

Locations

General Hospital, University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

LRS-01-06-01

Identifier Type: -

Identifier Source: org_study_id