Measurement of Core Temperatures During Therapeutic Hypothermia (TH)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | February 7, 2011 | ||||
| Last Updated Date | April 7, 2011 | ||||
| Start Date ICMJE | February 2011 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01292148 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Measurement of Core Temperatures During Therapeutic Hypothermia | ||||
| Official Title ICMJE | Core Temperature Measurement in Therapeutic Hypothermia: Tympanic Membrane, Bladder and Rectal Versus Pulmonary Artery Methods | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | post cardiac arrest care with therapeutic hypothermia |
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| Condition ICMJE | Cardiac Arrest | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | May 2012 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01292148 | ||||
| Other Study ID Numbers ICMJE | MCT-TH | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | JongHwan Shin, Seoul National University-Seoul Metropolitan Goverment Boramae Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||
| Collaborators ICMJE | Seoul National University Boramae Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Seoul National University Hospital | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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