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Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

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ClinicalTrials.gov Identifier: NCT00137527
Recruitment Status : Terminated
First Posted : August 30, 2005
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):
Atlantic Health System

Study Description
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Brief Summary:
The purpose of this study is to determine whether intraoperative brain oxygenation monitoring in cardiac surgery patients is effective in reducing postoperative neurologic and neurocognitive dysfunction.

Condition or disease Intervention/treatment Phase
Neurological Manifestations Device: Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion Not Applicable

Detailed Description:

This study represents a prospective, randomized assessment of the potential clinical and economic benefit to be derived from the continuous non-invasive monitoring of regional cerebral oxygen saturation (rSO2) during cardiac surgery employing cardiopulmonary bypass (CPB). Previous studies have shown that low rSO2 values obtained during surgery are highly associated with postoperative frontal lobe dysfunction, cognitive declines, disorientation, and other clinical indices of prolonged recovery. Low rSO2 values are thought to reflect the development of tissue hypoxia within susceptible regions of the cerebral cortex during the non-pulsatile perfusion of CPB. Rapid detection and correction of such episodes should help avoid regional hypoxia and its attendant postoperative sequelae. This study will assess neurologic, psychometric, and quality of life markers of brain dysfunction which could result from CPB. Each study patient will be assessed both pre- and postoperatively (pre-hospital discharge and at three months) for neurologic and neurocognitive dysfunction.

Comparison(s): Intervention versus control group. Patients assigned to the intervention rSO2-monitored group will be managed with conservative measures designed to maintain the rSO2 value at, or above, its preoperative value. Such measures include increases in pump flow, blood pressure, anesthetic dose, arterial oxygen tension, carbon dioxide tension, and hematocrit. Those patients in the control group will be managed according to current established practice. Although rSO2 is also recorded in this group, the monitor's readings are blinded.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Prospective, Randomized Trial of Cerebral Oximetry Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
Study Start Date : February 2004
Actual Study Completion Date : February 2009

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods

Secondary Outcome Measures :
  1. Relationship of intraoperative risk data to postoperative cognitive function

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary coronary artery bypass surgery
  • Ages 18-90
  • Voluntary participation with signed informed consent

Exclusion Criteria:

  • An unwillingness to participate in the study
  • Inability to obtain informed consent
  • Expressive or receptive aphasia
  • Inability to correctly perform the neurocognitive tests preoperatively
  • Inability to correctly perform the saccadic and anti-saccadic eye movement tests preoperatively
  • Non-English speaking candidates
  • Patients for whom it is known that follow-up will be improbable
  • Previous cardiac surgery
  • Concomitant procedures
  • Pre-existing psychotic disorders
  • Patients with active alcohol (ETOH) abuse requiring emergent surgery
  • Patients scoring 2 or higher on the CAGE evaluation
  • Mini-Mental State Exam preoperative score of 23 or less
  • Severe visual or auditory disorders
  • Parkinson's disease
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137527


Locations
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: James P Slater, MD Morristown Memorial Hospital
More Information
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Publications:

Responsible Party: Atlantic Health System
ClinicalTrials.gov Identifier: NCT00137527     History of Changes
Other Study ID Numbers: B03-07-008
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Atlantic Health System:
Cardiac Surgery
Cardiopulmonary Bypass
Cerebral Oxygenation
Neurologic Dysfunction
Neurocognitive Dysfunction
 Neurological manifestations
Memory loss
Delirium
Coronary Artery Bypass

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs