Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

NCT00137527 | Terminated

• 1 other identifier: B03-07-008
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Manifestations

Keywords

Cardiac Surgery; Cardiopulmonary Bypass; Cerebral Oxygenation; Neurologic Dysfunction; Neurocognitive Dysfunction; Neurological manifestations; Memory loss; Delirium; Coronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Relationship of intraoperative risk data to postoperative cognitive function

Interventions

Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion DEVICE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Related Publications (3)

• Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.

  PMID: 11172175 BACKGROUND

• Selnes OA, Grega MA, Borowicz LM Jr, Royall RM, McKhann GM, Baumgartner WA. Cognitive changes with coronary artery disease: a prospective study of coronary artery bypass graft patients and nonsurgical controls. Ann Thorac Surg. 2003 May;75(5):1377-84; discussion 1384-6. doi: 10.1016/s0003-4975(03)00021-3.

  PMID: 12735550 BACKGROUND

• Selnes OA, McKhann GM. Neurocognitive complications after coronary artery bypass surgery. Ann Neurol. 2005 May;57(5):615-21. doi: 10.1002/ana.20481.

  PMID: 15852408 BACKGROUND

MeSH Terms

Conditions

Neurologic Manifestations; Cognition Disorders; Memory Disorders; Delirium

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Confusion

Study Officials

• James P Slater, MD

  Morristown Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: February 1, 2004
• Study Completion: February 1, 2009
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

US (1)