Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Hospital, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2009 |
| End Date: | December 2010 |
| Contact: | Gregory Fischer, M.D. |
| Email: | gregory.fischer@mountsinai.org |
| Phone: | 212-241-7749 |
Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.
The purpose of this study is to determine whether brain oxygenation measured by cerebral
oximeter has an impact on neurocognitive dysfunction.
oximeter has an impact on neurocognitive dysfunction.
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.
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.
Inclusion Criteria:
- 65 and older
- Elective cardiac or thoracic aortic surgery
- Capable and willing to consent
- Participants literate in English
Exclusion Criteria:
- Emergency Surgery
- Major Neurological Disease
- Gross Cognitive Dysfunction
- Patients not expected to be able to complete the 1 week and 3 months post-operative
visit.
We found this trial at
2
sites
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
Click here to add this to my saved trials
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
Click here to add this to my saved trials