Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00410969
Status:
COMPLETED
Last Update Posted:
2008-09-29
First Post:
2006-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients
Sponsor:
Life Recovery Systems
Organization:
Study Overview
Official Title:
Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: