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Clinical Trials/NCT00137527
NCT00137527
Terminated
Not Applicable

Prospective, Randomized Trial of Cerebral Oximetry Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

Atlantic Health System1 site in 1 country250 target enrollmentFebruary 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurological Manifestations
Sponsor
Atlantic Health System
Enrollment
250
Locations
1
Primary Endpoint
Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods
Status
Terminated
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
February 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods

Secondary Outcomes

  • Relationship of intraoperative risk data to postoperative cognitive function

Study Sites (1)

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