Clinical trial NCT00991328: Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery
Official title: Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Post-Operative Delirium
Postoperative Cognitive Dysfunction
Keywords: PD
POCD
Post-op Delirium (PD)
Post-op Cognitive Dysfunction (POCD)
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether brain oxygenation measured by cerebral oximeter has an impact on neurocognitive dysfunction.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The association of Postoperative Delirium (PD) and Postoperative Cognitive Dysfunction (POCD) with changes in cerebral tissue oxygen saturation (SctO2).
timeFrame: First 5 days after the cardiac surgery.
Secondary outcomes:
measure: Postoperative Morbidity and Mortality
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Gregory Fischer, M.D.
role: PRINCIPAL_INVESTIGATOR
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