Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients
Primary Purpose
Postoperative Cognitive Dysfunction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
INVOS Somanetics Cerebral Oximeter
INVOS Somanetics Cerebral Oximeter
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Cognitive Dysfunction focused on measuring Aortic Surgeries, Deep Hypothermic Circulatory Arrest
Eligibility Criteria
Inclusion Criteria:
- Adult male and female patients 18-80 years of age scheduled for aortic surgery requiring DHCA and intention to use antegrade selective cerebral perfusion with or without RCP
Exclusion Criteria:
- Adult male and female patients 18-80 years of age undergoing aortic surgery NOT scheduled for DHCA
- Patients with ejection fraction < 15%
- Pregnancy
- Prisoners
- Patients mentally impaired (Screening Criteria i.e. MMSE score ≤ 23) History of stroke
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention INVOS Cerebral Oximetry Monitoring
Standard of Care
Arm Description
Intervention will be initiated if rSO2 drops > 20% from baseline or rSO2 declines below 50%.
Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Outcomes
Primary Outcome Measures
Mini Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.
Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems.
Mini Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.
Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01149148
Brief Title
Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients
Official Title
Effect of Regional Cerebral Oxygen Saturation Monitoring On Neurological Outcome In Patients Undergoing Aortic Arch Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that early intervention to optimize regional cerebral oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient and permanent neurological dysfunction and improve neurocognitive impairment.
Detailed Description
Permanent or transient neurologic dysfunction is a frequent complication in patients undergoing aortic arch surgery.
Two basic methods of brain protection are currently used concomitantly with these complex surgical procedures: deep hypothermic circulatory arrest (DHCA) with or without retrograde cerebral perfusion (RCP)and selective antegrade hypothermic cerebral perfusion. Hypothermic circulatory arrest provides an optimal bloodless operative field, but the incidence of neurological dysfunction increases when the duration of DHCA exceeds 45-50 minutes. Antegrade cerebral perfusion is accomplished by means of direct differential cannulation of the common carotid and right subclavian arteries. Because this technique of brain protection requires a separate perfusion circuit, vigilant monitoring of perfusion pressure and flow rate is of utmost importance. Multiple studies have demonstrated that antegrade selective cerebral perfusion is a well established technique used for cerebral protection during aortic surgery requiring longer periods of DHCA with favorable results in hospital mortality and neurologic outcome. The permanent neurological dysfunction was noted to be 3.8% and the transient neurologic dysfunction to be 7.1% for patients that received antegrade selective cerebral perfusion.
Similarly, neurocognitive studies of DHCA with antegrade cerebral perfusion for patients undergoing aortic arch operations demonstrated 9 % transient neurocognitive impairment for 2 days postoperatively that lasted up to 3 weeks thereafter. Consistent with current surgical practice, the University of Michigan uses antegrade selective cerebral perfusion for all patients undergoing aortic arch surgery requiring DHCA with or without RCP.
A number of monitoring modalities have been used for detecting cerebral malperfusion during aortic surgery or carotid surgery, including transcranial Doppler ultrasound and near infrared spectroscopy (NIRS).
The impact of these monitoring modalities on clinical (neurologic) outcome has not been clearly established. Currently, NIRS has gained considerable attention and acceptance as a non-invasive monitor of cerebral oxygenation. One study showed that a sustained drop in the regional oxygen saturation (rSO2) below 55% for over 5 minutes using cerebral oximetry is closely related to the occurrence of neurological events following aortic surgery. Another study strongly supported that rSO2 should not drop > 20% from baseline to prevent neurologic compromise. In a cohort of elective coronary artery bypass graph (CABG) patients, intervention for cerebral desaturations did show significantly less major organ morbidity or mortality (death, ventilation > 48 h, stroke, myocardial infarction, return for re-exploration. Whether NIRS can be used as a monitor to provide rapid detection and prevention of cerebral ischemia by early intervention that may improve neurological outcome in patients undergoing aortic surgery requiring DHCA with or without RCP is currently unknown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Aortic Surgeries, Deep Hypothermic Circulatory Arrest
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention INVOS Cerebral Oximetry Monitoring
Arm Type
Active Comparator
Arm Description
Intervention will be initiated if rSO2 drops > 20% from baseline or rSO2 declines below 50%.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Intervention Type
Device
Intervention Name(s)
INVOS Somanetics Cerebral Oximeter
Intervention Description
Sequence of Interventions To Increase Cerebral Oxygen Saturation
Check head and cannula position
Increase mean arterial pressure
Increase pump flow
Increase systemic oxygenation
Increase PaCO2 > 45
Increase anesthetic depth by increasing volatile anesthetic or by administering propofol boluses
Consider PRBC transfusion for Hct < 21%
Intervention Type
Device
Intervention Name(s)
INVOS Somanetics Cerebral Oximeter
Intervention Description
INVOS Cerebral Oximetry blinded monitoring with no deviation in surgical procedures or standard of care in anesthesia.
Primary Outcome Measure Information:
Title
Mini Mental State Examination (MMSE)
Description
The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.
Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems.
Time Frame
Baseline
Title
Mini Mental State Examination (MMSE)
Description
The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.
Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male and female patients 18-80 years of age scheduled for aortic surgery requiring DHCA and intention to use antegrade selective cerebral perfusion with or without RCP
Exclusion Criteria:
Adult male and female patients 18-80 years of age undergoing aortic surgery NOT scheduled for DHCA
Patients with ejection fraction < 15%
Pregnancy
Prisoners
Patients mentally impaired (Screening Criteria i.e. MMSE score ≤ 23) History of stroke
12. IPD Sharing Statement
Learn more about this trial
Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients
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