Phase 3
N=25
Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients
Postoperative Cognitive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01149148 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Aug 2012
Primary outcome: Primary: Mini Mental State Examination (MMSE) — 27; 26.769 scores on a scale — p=0.678
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- INVOS Somanetics Cerebral Oximeter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mini Mental State Examination (MMSE) |
27.667; 27 | — |
| PRIMARY Mini Mental State Examination (MMSE) |
27.667; 27 | — |
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 undergoing aortic surgery will decrease the incidence of transient and permanent neurological dysfunction and improve neurocognitive impairment.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01149148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.