Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery
NCT ID: NCT00991328
Last Updated: 2016-09-16
Study Results
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Basic Information
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TERMINATED
PHASE3
15 participants
INTERVENTIONAL
2009-09-30
2010-12-31
Brief Summary
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Detailed Description
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We believe that cerebral oximetry, a noninvasive technology that continuously monitors cerebral tissue oxygen saturation (SctO2), will enable us to answer the question of whether or not a correlation exists.
The availability of an absolute cerebral oximeter (FORE-SIGHT), with its ability to establish and manipulate threshold values for SctO2, provides us the opportunity to assess the relationship between cerebral oxygenation and the development of neurocognitive complications.
We propose a randomized, masked trial of 120 patients, adequately powered to assess the following:
* Is there an association between deficits in cerebral oxygenation and the occurrence of PD at some time in the 1st 5 days after the operation?
* Is there an association between deficits in cerebral oxygenation and changes in POCD scores shortly (5 days) after the operation and/or 4-6 weeks later? We hypothesize that individually tailored patient management guided with intraoperative and postoperative absolute cerebral oximetry monitoring using a tailored protocol designed to maintain SctO2 values above a specific threshold will result in improved neurocognitive outcomes in geriatric patients undergoing cardiac surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Cerebral Desaturation, i.e; SctO2 < 60 % for 5 minutes
Once the cerebral desaturation is established, the study personnel will attempt to optimize the level of oxygen within the brain of the study patients.
SctO2 < 60 %.
The following intervention protocol will be applied when SctO2 level falls below 60 %. First, the patients head position will be checked for suitable position and the face will be observed for plethora. Then the efforts will be made to maintain PaCO2 between 40-50 mmHg and MAP of 60 - 80 mm Hg. Cardiac index will be maintained between 2.0 - 2.5 L/min/m2. The hematocrit should be more than 20 %. The red blood cells or hemoconcentration will be used for this purpose.
Patients with SctO2 less than 60 %.
The study patients will not get any intervention in this arm if the Sct02 falls below 60%
No interventions assigned to this group
Interventions
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SctO2 < 60 %.
The following intervention protocol will be applied when SctO2 level falls below 60 %. First, the patients head position will be checked for suitable position and the face will be observed for plethora. Then the efforts will be made to maintain PaCO2 between 40-50 mmHg and MAP of 60 - 80 mm Hg. Cardiac index will be maintained between 2.0 - 2.5 L/min/m2. The hematocrit should be more than 20 %. The red blood cells or hemoconcentration will be used for this purpose.
Eligibility Criteria
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Inclusion Criteria
* Elective cardiac or thoracic aortic surgery
* Capable and willing to consent
* Participants literate in English
Exclusion Criteria
* Major Neurological Disease
* Gross Cognitive Dysfunction
* Patients not expected to be able to complete the 1 week and 3 months post-operative visit.
65 Years
ALL
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Gregory Fischer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai School of Medicine
New York, New York, United States
Countries
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References
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Other Identifiers
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GCO # 07-0332
Identifier Type: -
Identifier Source: org_study_id
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