Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes
NCT ID: NCT00151307
Last Updated: 2008-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2001-02-28
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Subjects will be assigned to a control and intervention group. Anesthesia and surgery will be performed as per usual standards of care. Patients in both groups will be monitored with an oxygen sensor placed over the forehead. The data will be recorded continuously on a floppy disk. The control group will be treated according to current standard of care; the readings of brain oxygen saturation will not be visible to the clinician. In the intervention group, the reading of brain oxygen saturation will be monitored by the anesthesiologist throughout surgery. Interventions will be performed to maintain cerebral oxygen saturations above 40%. Neuropsychological tests will be completed pre-operatively and at two time points post-operatively. The tests used are the ASEM (antisaccadic eye movement) and the MMSE (mini-mental state examination).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INVOS cerebral oximeter
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective cardiac surgery with cardiopulmonary bypass
* Coronary artery disease or valvular heart disease or combination of both
* Ability and willingness to give informed consent
Exclusion Criteria
* Emergency surgery
* Unable to understand English
* Allergic to tape used to attach oxygen sensor
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
New York Presbyterian Hospital
OTHER
Weill Medical College of Cornell University
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fun-Sun Yao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology; Weill Medical College of Cornell University, New York Presbyterian Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
New York Presbyterian Hospital, Weill Medical College of Cornell University
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0599-691
Identifier Type: -
Identifier Source: org_study_id