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Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

Primary Purpose

Neurological Manifestations

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurological Manifestations focused on measuring Cardiac Surgery, Cardiopulmonary Bypass, Cerebral Oxygenation, Neurologic Dysfunction, Neurocognitive Dysfunction, Neurological manifestations, Memory loss, Delirium, Coronary Artery Bypass

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Morristown Memorial Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Relationship of intraoperative risk data to postoperative cognitive function

Full Information

First Posted
August 26, 2005
Last Updated
January 16, 2014
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00137527
Brief Title
Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
Official Title
Prospective, Randomized Trial of Cerebral Oximetry Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlantic Health System

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Manifestations
Keywords
Cardiac Surgery, Cardiopulmonary Bypass, Cerebral Oxygenation, Neurologic Dysfunction, Neurocognitive Dysfunction, Neurological manifestations, Memory loss, Delirium, Coronary Artery Bypass

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion
Primary Outcome Measure Information:
Title
Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods
Secondary Outcome Measure Information:
Title
Relationship of intraoperative risk data to postoperative cognitive function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P Slater, MD
Organizational Affiliation
Morristown Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11172175
Citation
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. Erratum In: N Engl J Med 2001 Jun 14;344(24):1876.
Results Reference
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PubMed Identifier
12735550
Citation
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.
Results Reference
background
PubMed Identifier
15852408
Citation
Selnes OA, McKhann GM. Neurocognitive complications after coronary artery bypass surgery. Ann Neurol. 2005 May;57(5):615-21. doi: 10.1002/ana.20481.
Results Reference
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Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

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