Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery

Nonin Medical, Inc1 site in 1 country20 target enrollmentJuly 2011

ConditionsAortic Arch Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Arch Surgery
Sponsor: Nonin Medical, Inc
Enrollment: 20
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

May 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nonin Medical, Inc

Responsible Party

Sponsor

Eligibility Criteria

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

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(At the end of the surgical case approximately 6 to 8 hours)