Status:
COMPLETED
Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients
Lead Sponsor:
University of Michigan
Conditions:
Postoperative Cognitive Dysfunction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The investigators hypothesize that early intervention to optimize regional cerebral oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory arrest (DHCA) for patients ...
Detailed Description
Permanent or transient neurologic dysfunction is a frequent complication in patients undergoing aortic arch surgery. Two basic methods of brain protection are currently used concomitantly with these ...
Eligibility Criteria
Inclusion
- Adult male and female patients 18-80 years of age scheduled for aortic surgery requiring DHCA and intention to use antegrade selective cerebral perfusion with or without RCP
Exclusion
- Adult male and female patients 18-80 years of age undergoing aortic surgery NOT scheduled for DHCA
- Patients with ejection fraction \< 15%
- Pregnancy
- Prisoners
- Patients mentally impaired (Screening Criteria i.e. MMSE score ≤ 23) History of stroke
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01149148
Start Date
November 1 2009
End Date
September 1 2011
Last Update
April 28 2015
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