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Measurement of Core Temperatures During Therapeutic Hypothermia (TH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01292148
First Posted: February 9, 2011
Last Update Posted: July 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Jong Hwan Shin, Seoul National University Hospital
  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:


Further study details as provided by Jong Hwan Shin, Seoul National University Hospital:

Primary Outcome Measures:
  • Difference of core temperature between rectum, bladder, esophagus and pulmonary artery [ Time Frame: During 24 hour ]

Enrollment: 20
Study Start Date: February 2011
Study Completion Date: May 2012
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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Post cardiac arrest care with therapeutic hypothermia
Criteria

Inclusion 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.

Exclusion 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292148


Locations
Korea, Republic of
Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Investigators
Principal Investigator: Shin JongHwan Seoul National University Boramae Hospital
  More Information

Responsible Party: Jong Hwan Shin, Seoul National University, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01292148     History of Changes
Other Study ID Numbers: MCT-TH
First Submitted: February 7, 2011
First Posted: February 9, 2011
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Jong Hwan Shin, Seoul National University Hospital:
resuscitation, hypothermia

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