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Measurement of Core Temperatures During Therapeutic Hypothermia (TH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Seoul National University Boramae Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01292148
First received: February 7, 2011
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

The purpose of this study is to determine that the measurements of rectal and bladder temperature are correctly consistent with core temperature by using the pulmonary artery catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming phase.


Condition
Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Core Temperature Measurement in Therapeutic Hypothermia: Tympanic Membrane, Bladder and Rectal Versus Pulmonary Artery Methods

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The guidelines of therapeutic hypothermia(TH)are rapid cooling, from normothermia to mild hypothermia(32~34 degree), maintenance, and slow rewarming phase. If core temperature maintained below 32 degree during TH, som complications will be developed, such as arrythmia, hypotension, cold diuresis, coagulopathy, and so on. Therefore correct measurement of core temperature during TH is very important process for successful post cardiac arrest care. we will know that rectal or bladder temperature are really reflect the core temperature during TH for post cardiac arrest care, especially rapid cooling phase, maintenance phase, and slow rewarming phase, respectively.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

post cardiac arrest care with therapeutic hypothermia

Criteria

Inclusion Criteria:

  • in hospital arrest.
  • arrest due to trauma
  • arrest due to intracranial hemorrhage.
  • below 30 degree at initial core temperature.
  • pregnancy.
  • family do not agree with our study.
  • active bleeding patient.

Exclusion Criteria:

  • out of cardiac arrest patient who is 18 years old.
  • mean arterial pressure must be over 65 mmHg after return of spontaneous circulation.
  • family consent to this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292148

Contacts
Contact: Shin JongHwan +82-2-870-2662 skyshin1@dreamwiz.com

Locations
Korea, Republic of
Seoul National University Boramae Hospital Recruiting
Seoul, Korea, Republic of, 156-707
Contact: JongHwan Shin, Dr.     +82-2-870-2662     skyshin1@dreamwiz.com    
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Boramae Hospital
Investigators
Principal Investigator: Shin JongHwan Seoul National University Boramae Hospital
  More Information

No publications provided

Responsible Party: JongHwan Shin, Seoul National University-Seoul Metropolitan Goverment Boramae Hospital
ClinicalTrials.gov Identifier: NCT01292148     History of Changes
Other Study ID Numbers: MCT-TH
Study First Received: February 7, 2011
Last Updated: April 7, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
resuscitation, hypothermia

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013