Postoperative Cognitive Dysfunction Clinical Trial
Official title:
Effect of Regional Cerebral Oxygen Saturation Monitoring On Neurological Outcome In Patients Undergoing Aortic Arch Surgery
Verified date | August 2012 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | September 2011 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Michigan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mini Mental State Examination (MMSE) | The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status. Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems. |
Baseline | No |
Primary | Mini Mental State Examination (MMSE) | The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status. Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems. |
3 Months | No |
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