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Safety and Feasibility of Endovascular Cooling Device in Patients With Hypothermic Cardiopulmonary Resuscitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154674
First received: September 8, 2005
Last updated: November 21, 2005
Last verified: January 2004
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Arrest
 Device: ICY catheter, Thermoguard device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • complications and feasibility of endovascular cooling device

Estimated Enrollment: 15
Study Start Date: April 2005
Estimated Study Completion Date: October 2005
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 0.5C/hr 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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-traumatic collapsed patients, whose pulsation continues and persists more than 5 minutes after return of spontaneous circulation from cardiopulmonary resuscitation and consciousness level is less than GCS 5 points.

Exclusion Criteria:

  • 1. Age > 78 y/o or < 18 y/o 2. Core temperature< 34℃or > 38 ℃ after resuscitation 3. Pregnancy 4. Underline terminal malignancy disorder or refuse aggressive treatment cancer patient 5. Massive bleeding, known coagulopathy, or received regular anticoagulant medication 6. Persisted hypotension ( mean arterial BP < 60 mmHg) after resuscitation even under inotropic agents 7. No bed available in ICU
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154674

Contacts
Contact: Chiung Yuan Hsu, MD 886-2-23123456 ext 2831 dtemer01@yahoo.com.tw
Contact: Wen Jone Chen, PHD 886-2-23123456 ext 2831 jone@ha.mc.ntu.edu.tw

Locations
Taiwan
NTUH Recruiting
Taipei, Taiwan, 100
Contact: Chiung Yuan Hsu, MD     886-2-23123456 ext 5926     dtemer01@yahoo.com.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen Jone Chen, PHD NTUH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154674     History of Changes
Other Study ID Numbers: 25MD03
Study First Received: September 8, 2005
Last Updated: November 21, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013