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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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 21, 2010
    Last Updated
    April 27, 2015
    Sponsor
    University of Michigan
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    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

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    Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

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