Measurement of Core Temperatures During Therapeutic Hypothermia

Cardiac Arrest Clinical Trial

— TH  

Official title:

Core Temperature Measurement in Therapeutic Hypothermia: Tympanic Membrane, Bladder and Rectal Versus Pulmonary Artery Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292148
• Other study ID #: MCT-TH
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: July 17, 2015
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of core temperature between rectum, bladder, esophagus and pulmonary artery		During 24 hour	No