Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151307
Status:
TERMINATED
Last Update Posted:
2008-06-06
First Post:
2005-09-06
Brief Title:
Effects of Cerebral Oxygen Saturation on Neuropsychological Outcomes
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Could not recruit any more people
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation over 40 on patients undergoing cardiac surgery Effects on neuropsychological outcome length of ICU stay and length of hospital stay will be measured
Detailed Description:
Central nervous system dysfunction is a major cause of morbidity after cardiac surgery This study seeks to evaluate the effects of cerebral oxygen saturation on the neuropsychological outcome of cardiac surgery patients Currently monitoring of cerebral oxygen saturation levels is not part of routine and standard practice
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None