- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01292148
Measurement of Core Temperatures During Therapeutic Hypothermia (TH)
July 17, 2015 updated by: Jong Hwan Shin, Seoul National University Hospital
Core Temperature Measurement in Therapeutic Hypothermia: Tympanic Membrane, Bladder and Rectal Versus Pulmonary Artery Methods
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 156-707
- Seoul National University Boramae Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Post cardiac arrest care with therapeutic hypothermia
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference of core temperature between rectum, bladder, esophagus and pulmonary artery
Time Frame: During 24 hour
|
During 24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Shin JongHwan, Seoul National University Boramae Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
February 7, 2011
First Submitted That Met QC Criteria
February 7, 2011
First Posted (Estimate)
February 9, 2011
Study Record Updates
Last Update Posted (Estimate)
July 21, 2015
Last Update Submitted That Met QC Criteria
July 17, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCT-TH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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