Aortic Arch Surgery
Conditions
Keywords
Near infrared spectroscopy, neuromonitoring, aortic arch surgery
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.
Interventions
None listed
Sponsors
Nonin Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed