Neurological ManifestationsNCT00137527
Brain Oxygenation Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
A study testing Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion in people with Neurological Manifestations, run by Atlantic Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurological Manifestations
- What is being tested?
- Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary coronary artery bypass surgery
- Ages 18-90
- Voluntary participation with signed informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Memorial Hospital
Morristown, New Jersey, 07962
About this study
Official title: Prospective, Randomized Trial of Cerebral Oximetry Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
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.
Read the 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.
- Conditions
- Neurological Manifestations
- Being tested
- Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion
- Keywords
- Cardiac Surgery, Cardiopulmonary Bypass, Cerebral Oxygenation, Neurologic Dysfunction, Neurocognitive Dysfunction, Neurological manifestations, Memory loss, Delirium, Coronary Artery Bypass
- Medical subject headings
- Neurologic Manifestations, Cognition Disorders, Memory Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startFeb 2004
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neurological ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James P Slater, MD, Principal investigator, Morristown Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137527
- Sponsor's protocol ID
- B03-07-008
- Status last verified
- Jan 2014
- First submitted
- 26 Aug 2005
- Last updated
- 17 Jan 2014
- Results posted
- No
Publications
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.
PubMed 11172175Selnes 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.
PubMed 12735550Selnes OA, McKhann GM. Neurocognitive complications after coronary artery bypass surgery. Ann Neurol. 2005 May;57(5):615-21. doi: 10.1002/ana.20481.
PubMed 15852408
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Cerebral Oximetry Monitoring in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT00137527
- Acronym / sponsor ID
- B03-07-008
- Conditions
- Neurological Manifestations
- Keywords
- Cardiac Surgery, Cardiopulmonary Bypass, Cerebral Oxygenation, Neurologic Dysfunction, Neurocognitive Dysfunction, Neurological manifestations, Memory loss, Delirium
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 250 participants
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary coronary artery bypass surgery
- Ages 18-90
- Voluntary participation with signed informed consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion | Device | – |
Primary outcome
Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods
1 secondary outcome
Relationship of intraoperative risk data to postoperative cognitive function
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Background: PubMed 11172175Newman 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.
- Background: PubMed 12735550Selnes 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.
- Background: PubMed 15852408Selnes OA, McKhann GM. Neurocognitive complications after coronary artery bypass surgery. Ann Neurol. 2005 May;57(5):615-21. doi: 10.1002/ana.20481.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P Slater, MD principal investigator
Morristown Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimizing hemodynamic and anesthetic parameters to improve cerebral perfusion in people with Neurological Manifestations, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function measured by neurocognitive tests administered in the preoperative, immediate postoperative, and three months postoperative periods. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00137527, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.