NCT00384319

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Life Recovery Systems · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	ThermoSuit(R) System	The ThermoSuit device is used to cool patients using direct contact of the skin with cold water.

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-06-01
• Completion: 2007-12-01
• First posted: 2006-10-06
• Last updated: 2008-01-04

Locations

1 site across 1 country: Austria