Near Infrared Spectroscopy (NIRS)

Nonin Medical, Inc20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Arch Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: At the end of the surgical case approximately 6 to 8 hours

Secondary Outcomes

Determine whether there are unilateral or global differences in cerebral tissue oxygenation detected during selective antegrade cerebral perfusion

Time frame: At the end of the surgical case approximately 6 to 8 hours

Data from ClinicalTrials.gov

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