Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery
Primary Purpose
Post-Operative Delirium, Postoperative Cognitive Dysfunction
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SctO2 < 60 %.
Sponsored by
About this trial
This is an interventional prevention trial for Post-Operative Delirium focused on measuring PD, POCD, Post-op Delirium (PD), Post-op Cognitive Dysfunction (POCD)
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.
Sites / Locations
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Cerebral Desaturation, i.e; SctO2 < 60 % for 5 minutes
Patients with SctO2 less than 60 %.
Arm Description
Once the cerebral desaturation is established, the study personnel will attempt to optimize the level of oxygen within the brain of the study patients.
The study patients will not get any intervention in this arm if the Sct02 falls below 60%
Outcomes
Primary Outcome Measures
The association of Postoperative Delirium (PD) and Postoperative Cognitive Dysfunction (POCD) with changes in cerebral tissue oxygen saturation (SctO2).
Secondary Outcome Measures
Postoperative Morbidity and Mortality
Full Information
NCT ID
NCT00991328
First Posted
October 2, 2009
Last Updated
September 14, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT00991328
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Delirium, Postoperative Cognitive Dysfunction
Keywords
PD, POCD, Post-op Delirium (PD), Post-op Cognitive Dysfunction (POCD)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cerebral Desaturation, i.e; SctO2 < 60 % for 5 minutes
Arm Type
Active Comparator
Arm Description
Once the cerebral desaturation is established, the study personnel will attempt to optimize the level of oxygen within the brain of the study patients.
Arm Title
Patients with SctO2 less than 60 %.
Arm Type
No Intervention
Arm Description
The study patients will not get any intervention in this arm if the Sct02 falls below 60%
Intervention Type
Procedure
Intervention Name(s)
SctO2 < 60 %.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Postoperative Morbidity and Mortality
Time Frame
3 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Fischer, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery
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