Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery
Postoperative Cognitive Dysfunction
Procedure: SctO2 < 60 %.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.|
- The association of Postoperative Delirium (PD) and Postoperative Cognitive Dysfunction (POCD) with changes in cerebral tissue oxygen saturation (SctO2). [ Time Frame: First 5 days after the cardiac surgery. ] [ Designated as safety issue: No ]
- Postoperative Morbidity and Mortality [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Cerebral Desaturation, i.e; SctO2 < 60 % for 5 minutes
Once the cerebral desaturation is established, the study personnel will attempt to optimize the level of oxygen within the brain of the study patients.
Procedure: SctO2 < 60 %.
The following intervention protocol will be applied when SctO2 level falls below 60 %. First, the patients head position will be checked for suitable position and the face will be observed for plethora. Then the efforts will be made to maintain PaCO2 between 40-50 mmHg and MAP of 60 - 80 mm Hg. Cardiac index will be maintained between 2.0 - 2.5 L/min/m2. The hematocrit should be more than 20 %. The red blood cells or hemoconcentration will be used for this purpose.
No Intervention: Patients with SctO2 less than 60 %.
The study patients will not get any intervention in this arm if the Sct02 falls below 60%
Both postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are well known complications seen in elderly patients after cardiac surgery. The etiologies of PD and POCD are unknown, but cerebral ischemia remains a prime candidate. Attempts to correlate reduced levels of systemic oxygenation (i.e. SpO2) with the development of PD/POCD have been to date disappointing.
We believe that cerebral oximetry, a noninvasive technology that continuously monitors cerebral tissue oxygen saturation (SctO2), will enable us to answer the question of whether or not a correlation exists.
The availability of an absolute cerebral oximeter (FORE-SIGHT), with its ability to establish and manipulate threshold values for SctO2, provides us the opportunity to assess the relationship between cerebral oxygenation and the development of neurocognitive complications.
We propose a randomized, masked trial of 120 patients, adequately powered to assess the following:
- Is there an association between deficits in cerebral oxygenation and the occurrence of PD at some time in the 1st 5 days after the operation?
- Is there an association between deficits in cerebral oxygenation and changes in POCD scores shortly (5 days) after the operation and/or 4-6 weeks later? We hypothesize that individually tailored patient management guided with intraoperative and postoperative absolute cerebral oximetry monitoring using a tailored protocol designed to maintain SctO2 values above a specific threshold will result in improved neurocognitive outcomes in geriatric patients undergoing cardiac surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991328
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Gregory Fischer, M.D.||Icahn School of Medicine at Mount Sinai|