Tissue Oxygenation During Heart Surgery
Study Details
Study Description
Brief Summary
The goal of this study is to determine if off-pump CABG surgery is associated with better cerebral tissue oxygenation when compared with on-pump CABG. In addition, the investigators would like to compare the results of two different monitors of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation (ScvO2). Finally, the investigators aim to determine if duration and extent of cerebral oxygen desaturation predict outcome variables such as postoperative cognitive performance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| on pump Coronary artery bypass grafting (CABG)with with cardiopulmonary bypass |
Device: measurements of brain tissue oxygenation
different monitors((the Hutchinson InSpectra™ StO2 Tissue Oxygenation Monitor) and in cerebral (ForeSight® Cerebral Oximeter and the Somanetics INVOS® Cerebral Oximeter ) and renal tissue (the Somanetics INVOS® Cerebral Oximeter)of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation
|
| off pump off-pump CABG surgery |
Device: measurements of brain tissue oxygenation
different monitors((the Hutchinson InSpectra™ StO2 Tissue Oxygenation Monitor) and in cerebral (ForeSight® Cerebral Oximeter and the Somanetics INVOS® Cerebral Oximeter ) and renal tissue (the Somanetics INVOS® Cerebral Oximeter) of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation
|
Outcome Measures
Primary Outcome Measures
- incidence of significant brain tissue oxygen desaturation, defined as AUC40 > 600 %.sec (a function of both duration (in seconds) and severity (saturation < 40%) of desaturation). [3 months]
Secondary Outcome Measures
- Oxygenation measurements: Peripheral muscle StO2, cerebral and renal StO2, ScvO2, SaO2, arteriovenous oxygen difference, pO2 Acid-base status: pH, pCO2, HCO3-, ABE, lactate [3 months]
To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with each other To determine if oxygenation measurements obtained in peripheral (thenar) muscle, renal tissue and in cerebral tissue correlate with conventional hemodynamic and metabolic variables such as central venous oxygen saturation (ScvO2).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years
-
Informed patient consent
-
Coronary artery disease suitable for both on-pump and off-pump CABG surgery.
Exclusion Criteria:
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History of head trauma or stroke causing significant active neurologic disease
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History of neurosurgery
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Severe or symptomatic carotid artery disease
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Requirement for valve surgery in addition to CABG
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Pre-existing acute or chronic renal dysfunction
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Urgent or emergency surgery
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Difficulty with cognitive testing: impaired hearing or eyesight, poor Dutch language comprehension, disability impairing the usage of the hand or arm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Groningen | Groningen | Netherlands |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: Thomas W.L. Scheeren, Prof.dr, University Medical Center Groningen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TO-CABG