Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154674
Status:
UNKNOWN
Last Update Posted:
2005-11-22
First Post:
2005-09-08
Brief Title:
Safety and Feasibility of Endovascular Cooling Device in Patients With Hypothermic Cardiopulmonary Resuscitation
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2004-01
Last Known Status:
RECRUITING
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:
Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically However traditional cooling devices and methods most external cooling methods include ice blanket cooling helmet or ice packing lower the body temperature slowly or inefficiently which make many emergency physicians hesitate to perform hypothermic resuscitation To improve and promote the practice of hypothermia resuscitation more efficient temperature control method is necessary We conduct this clinical trial to evaluate the safety and feasibility of internal cooling catheter and temperature regulatory device which is approved by FDA in neurologic ICU for temperature control in the cardiac arrest patients
Detailed Description:
We recruited successful resuscitated nontraumatic cardiac arrest adult patients in the emergency department to evaluate the safety and feasibility of application those invasive internal temperature regulator devices Internal cooling catheter ICY and thermal regulator device Coolguard 2000 are applied to the patients from femoral vein WE definite 4 stages according to the temperature during the clinical trial The Cooling Phase Hypothermia phase Rewarming phase and Postrewarming phase The temperature is lowed or elevated by the rate 05Chr during the Cooling and Rewarming Phase and it is maintained 33 - 1 C during hypothermia phase for 12 hours according to the comment of ACLS To understand the safety and feasibility regular blood sampling bedside EEG and vital monitors and special sheets are designed to document the every reasons time points or every clinical events during hypothermia therapy The patients is observed until rewarming finish for 48 hours or till death if expired during post-resuscitation hypothermia therapy
Study Oversight
Has Oversight DMC:
None
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?:
None