Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neurological Manifestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No