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TH: Measurement of Core Temperatures During Therapeutic Hypothermia

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01292148
Collaborator
SMG-SNU Boramae Medical Center (Other)
20
Enrollment
1
Location
14.9
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Core Temperature Measurement in Therapeutic Hypothermia: Tympanic Membrane, Bladder and Rectal Versus Pulmonary Artery Methods
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Feb 1, 2012
    Actual Study Completion Date :
    May 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Difference of core temperature between rectum, bladder, esophagus and pulmonary artery [During 24 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jong Hwan Shin, Seoul National University, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01292148
    Other Study ID Numbers:
    • MCT-TH
    First Posted:
    Feb 9, 2011
    Last Update Posted:
    Jul 21, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by Jong Hwan Shin, Seoul National University, Seoul National University Hospital
    resuscitation, hypothermia
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of Jul 21, 2015