Near Infrared Spectroscopy (NIRS)
Completed
- Conditions
- Aortic Arch Surgery
- Registration Number
- NCT01429324
- Lead Sponsor
- Nonin Medical, Inc
- Brief Summary
This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Is male or female
- Is of any race or ethnicity
- Is greater than or equal to eighteen (18) years of age
- Weighs greater than or equal to 40 kilogram
- Is not known to be pregnant
- Understands English
- Is undergoing aortic arch surgery with planned deep hypothermia circulatory arrest, either with or without select antegrade cerebral perfusion
- Is able and willing to provide informed consent
Exclusion Criteria
- Is less than eighteen (18) years of age
- Weighs less than 40 kilogram
- Is known to be pregnant
- Does not understand English
- Has known sensitivity to adhesives
- Is unable or unwilling to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate brain tissue oxygenation assessing the number and percentage of subjects from whom regional data could be collected during 90% of the aortic arch surgery, and the registration rate during deep hypothermic circulatory arrest. At the end of the surgical case approximately 6 to 8 hours
- Secondary Outcome Measures
Name Time Method Determine whether there are unilateral or global differences in cerebral tissue oxygenation detected during selective antegrade cerebral perfusion At the end of the surgical case approximately 6 to 8 hours
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States