Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery

Neurological Manifestations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00137527
• Other study ID #: B03-07-008
• Status: Terminated
• Phase: N/A
• First received: August 26, 2005
• Last updated: January 16, 2014
• Start date: February 2004
• Est. completion date: February 2009

Study information

• Verified date: January 2014
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurologic Manifestations
• Neurological Manifestations

Intervention

Device:
• Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion

Locations

Country	Name	City	State
United States	Morristown Memorial Hospital	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: N Engl J Med 2001 Jun 14;344(24):1876. — View 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. — View Citation

Selnes OA, McKhann GM. Neurocognitive complications after coronary artery bypass surgery. Ann Neurol. 2005 May;57(5):615-21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods
Secondary	Relationship of intraoperative risk data to postoperative cognitive function