<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036345</url>
  </required_header>
  <id_info>
    <org_study_id>ISR-2016-10757</org_study_id>
    <nct_id>NCT03036345</nct_id>
  </id_info>
  <brief_title>Cerebral Perfusion in the Beach Chair Position</brief_title>
  <official_title>Prediction of Post-operative Cognitive Decline Following Shoulder Surgery in the Beach Chair Position: The Value of Cerebral Oximetry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brisbane Hand and Upper Limb Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>CAS Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brisbane Hand and Upper Limb Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgery to the shoulder may be performed with patients seated upright in a position known as&#xD;
      the &quot;Beach Chair Position (BCP).&quot; This position has certain advantages compared to&#xD;
      alternative surgical positions (e.g. side lying) in some situations. However, it has been&#xD;
      found that surgery in the BCP can temporarily decrease the amount of oxygen in the brain as a&#xD;
      result of the combined effects of gravity and anaesthesia. This can result in complications&#xD;
      following surgery such as some memory loss and confusion. Rarely, more serious complications&#xD;
      have been reported in the past including death and stroke.&#xD;
&#xD;
      Due to these reported complications the use of &quot;cerebral oximetry&quot; during shoulder surgery in&#xD;
      the BCP has become more common. Before and during surgery, a monitor placed on the patients&#xD;
      forehead measures the amount of oxygen present in the brain to help control this to an&#xD;
      acceptable level. A number of monitors are now commercially available. Two monitors are&#xD;
      commonly discussed in the literature; the INVOS™ 5100 and the FORE-SIGHT® machines. However,&#xD;
      the actual relationship between the supply of oxygen to the brain during surgery and the&#xD;
      chance of later developing problems with memory and thinking (known as &quot;post operative&#xD;
      cognitive decline&quot; - POCD) is not clear. It is also not known if one monitor is more accurate&#xD;
      than another at predicting these complications.&#xD;
&#xD;
      Therefore, the main aim of this study is to examine the relationship between cerebral oxygen&#xD;
      levels during shoulder surgery and the incidence of POCD (i.e. problems with memory and&#xD;
      thinking). A second aim is to compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to&#xD;
      measure cerebral oxygen and cerebral desaturation events (CDEs) as well as the importance of&#xD;
      other key clinical variables (e.g. blood pressure, nausea, body fat etc).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE OF THE INVESTIGATION The purpose of this investigation is to generate evidence about&#xD;
      cerebral oxygenation during shoulder surgery and the incidence of POCD. Currently, evidence&#xD;
      relating to POCD following surgery is conflicting and relates mostly to outcomes following&#xD;
      cardiac surgery. There is a strong need to explore this relationship in the specific context&#xD;
      of shoulder surgery in the BCP.&#xD;
&#xD;
      INTERVENTION GROUPS This study will involve a single prospective cohort. Patients who meet&#xD;
      the selection criteria will be recruited to the study following voluntary informed consent .&#xD;
      Cerebral oxygenation will be measured by application of cerebral oximeters to each patients&#xD;
      forehead.&#xD;
&#xD;
      AIM OF THE STUDY This study has three aims; (i) To examine the relationship between cerebral&#xD;
      desaturation during shoulder surgery in the BCP, and the incidence of POCD.&#xD;
&#xD;
      (ii) To determine the variation in cerebral oxygenation recorded using randomised (for&#xD;
      superior/inferior) simultaneous application of the INVOS™ and FORE-SIGHT® oximeters, during&#xD;
      shoulder surgery in the beach chair position.&#xD;
&#xD;
      (iii) Assess the relationships between cerebral oxygen desaturation during shoulder surgery&#xD;
      in the BCP and variables including mean arterial pressure, incidence of nausea/vomiting,&#xD;
      duration of hospital stay, BMI, hypertension and adverse events.&#xD;
&#xD;
      RESEARCH QUESTION There are three research questions correlating with the three research&#xD;
      aims; (i) Is cerebral desaturation during shoulder surgery associated with POCD? (ii) Do the&#xD;
      FORE-SIGHT® and INVOS™ 5100 devices vary in their measurement of cerebral oxygenation during&#xD;
      shoulder surgery in the BCP? (iii) Is there a relationship between cerebral desaturation&#xD;
      events during shoulder surgery in the BCP and variables including mean arterial blood&#xD;
      pressure, post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any&#xD;
      adverse events?&#xD;
&#xD;
      NULL HYPOTHESES The three null hypotheses are; (i) Cerebral desaturation as measured using&#xD;
      cerebral oximetry is not related to POCD after shoulder surgery in the BCP.&#xD;
&#xD;
      (ii) There is no significant difference between the INVOS™ 5100 and the FORE-SIGHT® monitors&#xD;
      assessment of cerebral oxygenation during shoulder surgery in the BCP.&#xD;
&#xD;
      (iii) There is no relationship between cerebral desaturation events during shoulder surgery&#xD;
      in the BCP and variables including mean arterial blood pressure, the frequency of&#xD;
      post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse&#xD;
      events.&#xD;
&#xD;
      PRIMARY HYPOTHESES The primary research hypotheses are; (i) Cerebral desaturation events&#xD;
      during surgery in the BCP will be related to POCD.&#xD;
&#xD;
      (ii) The INVOS™ 5100 and the FORE-SIGHT® monitors will show no significant difference in&#xD;
      their ability to measure cerebral oxygenation.&#xD;
&#xD;
      (iii) Cerebral desaturation events experienced during shoulder surgery in the BCP are related&#xD;
      to a drop in mean arterial blood pressure, an increased likelihood of post-operative nausea&#xD;
      and vomiting, greater length of hospital stay, a higher BMI, hypertension and greater&#xD;
      frequency of adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trail making test: Delis-Kaplan Executive Function System</measure>
    <time_frame>Baseline</time_frame>
    <description>The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail making test: Delis-Kaplan Executive Function System</measure>
    <time_frame>1 day post-operative</time_frame>
    <description>The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail making test: Delis-Kaplan Executive Function System</measure>
    <time_frame>8-14 days post-operative</time_frame>
    <description>The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail making test: Delis-Kaplan Executive Function System</measure>
    <time_frame>6 weeks post-operative</time_frame>
    <description>The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail making test: Delis-Kaplan Executive Function System</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single letter verbal fluency</measure>
    <time_frame>Baseline</time_frame>
    <description>This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single letter verbal fluency</measure>
    <time_frame>1 day post-operative</time_frame>
    <description>This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single letter verbal fluency</measure>
    <time_frame>8-14 days post-operative</time_frame>
    <description>This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single letter verbal fluency</measure>
    <time_frame>6 weeks post-operative</time_frame>
    <description>This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single letter verbal fluency</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rey Auditory Verbal Learning Test</measure>
    <time_frame>Baseline</time_frame>
    <description>The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rey Auditory Verbal Learning Test</measure>
    <time_frame>1 day post-operative</time_frame>
    <description>The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rey Auditory Verbal Learning Test</measure>
    <time_frame>8-14 days post-operative</time_frame>
    <description>The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rey Auditory Verbal Learning Test</measure>
    <time_frame>6 weeks post-operative</time_frame>
    <description>The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rey Auditory Verbal Learning Test</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)</measure>
    <time_frame>Baseline</time_frame>
    <description>The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)</measure>
    <time_frame>1 day post-operative</time_frame>
    <description>The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)</measure>
    <time_frame>8-14 days post-operative</time_frame>
    <description>The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)</measure>
    <time_frame>6 weeks post-operative</time_frame>
    <description>The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)</measure>
    <time_frame>3 months post-operative</time_frame>
    <description>The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cerebral desaturation events (INVOS)</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral desaturation events (FORE-SIGHT)</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial pressure</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Mean arterial blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient Body Mass Index (BMI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient-reported hypertension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea and vomiting within 48 hours</measure>
    <time_frame>1 day, 8-14 days</time_frame>
    <description>Patient-reported nausea and vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>8-14 days</time_frame>
    <description>Patient duration of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment stage and recorded on a data collection form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 day</time_frame>
    <description>Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>8-14 days</time_frame>
    <description>Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 weeks</time_frame>
    <description>Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression Anxiety and Stress Scale-21</measure>
    <time_frame>Baseline, 1 day, 8-14 days, 6 weeks, 3 months</time_frame>
    <description>The DASS-21 has 21 questions that index the level of depression, anxiety and stress an individual has experienced in the preceding week.</description>
  </other_outcome>
  <other_outcome>
    <measure>Social Relationships and Support Scale</measure>
    <time_frame>Baseline, 1 day, 8-14 days, 6 weeks, 3 months</time_frame>
    <description>The social support measures address the issues of social process in a range different clinical populations.</description>
  </other_outcome>
  <other_outcome>
    <measure>Loneliness Scale</measure>
    <time_frame>Baseline, 1 day, 8-14 days, 6 weeks, 3 months</time_frame>
    <description>A standardised 3-item Loneliness scale, comprised of items from the well-validated University of California, Los Angeles (UCLA) Loneliness scale.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Surgery patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dual-monitoring</intervention_name>
    <description>Monitored using both INVOS and FORE-SIGHT monitors.</description>
    <arm_group_label>Surgery patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Receiving treatment primarily by, but not restricted to, one of the Primary&#xD;
             investigators for a shoulder condition that requires surgery in the BCP.&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Pre-operative Mini-Mental State Examination (MMSE) &lt; 24&#xD;
&#xD;
          -  Pre-existing cerebrovascular disease as reported by the assessing medical consultant&#xD;
             and recorded in patient charts&#xD;
&#xD;
          -  Orthostatic hypotension&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) physical status III, IV and V*&#xD;
&#xD;
          -  History of drug and/or alcohol abuse&#xD;
&#xD;
          -  Neurological disease (e.g. previous stroke)&#xD;
&#xD;
          -  Significant mood and anxiety disorders as determined by treating consultant.&#xD;
&#xD;
          -  Any other condition, which in the opinion of the investigators, would render the&#xD;
             patient unsuitable for participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Ross, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Silvia Manzanero, PhD</last_name>
    <phone>+61 7 3834 7069</phone>
    <email>researchmanager@upperlimb.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Ross, MBBS</last_name>
    <phone>+61 7 3834 6592</phone>
    <email>markross@upperlimb.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Brisbane Hand and Upper Limb Research Institute, Brisbane Private Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvia Manzanero, PhD</last_name>
      <phone>+61 7 3834 7069</phone>
      <email>researchmanager@upperlimb.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <link>
    <url>http://www.upperlimb.com</url>
    <description>Brisbane Hand and Upper Limb Research Institute</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified cerebral oximeter data acquisition files will be made available to the equipment manufacturers (Medtronic, CASMED) at the conclusion of the study.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03036345/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036345
org study id: ISR-2016-10757
nct id: NCT03036345
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgery to the shoulder may be performed with patients seated upright in a position known as
      the "Beach Chair Position (BCP)." This position has certain advantages compared to
      alternative surgical positions (e.g. side lying) in some situations. However, it has been
      found that surgery in the BCP can temporarily decrease the amount of oxygen in the brain as a
      result of the combined effects of gravity and anaesthesia. This can result in complications
      following surgery such as some memory loss and confusion. Rarely, more serious complications
      have been reported in the past including death and stroke.

      Due to these reported complications the use of "cerebral oximetry" during shoulder surgery in
      the BCP has become more common. Before and during surgery, a monitor placed on the patients
      forehead measures the amount of oxygen present in the brain to help control this to an
      acceptable level. A number of monitors are now commercially available. Two monitors are
      commonly discussed in the literature; the INVOS™ 5100 and the FORE-SIGHT® machines. However,
      the actual relationship between the supply of oxygen to the brain during surgery and the
      chance of later developing problems with memory and thinking (known as "post operative
      cognitive decline" - POCD) is not clear. It is also not known if one monitor is more accurate
      than another at predicting these complications.

      Therefore, the main aim of this study is to examine the relationship between cerebral oxygen
      levels during shoulder surgery and the incidence of POCD (i.e. problems with memory and
      thinking). A second aim is to compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to
      measure cerebral oxygen and cerebral desaturation events (CDEs) as well as the importance of
      other key clinical variables (e.g. blood pressure, nausea, body fat etc).
PURPOSE OF THE INVESTIGATION The purpose of this investigation is to generate evidence about
      cerebral oxygenation during shoulder surgery and the incidence of POCD. Currently, evidence
      relating to POCD following surgery is conflicting and relates mostly to outcomes following
      cardiac surgery. There is a strong need to explore this relationship in the specific context
      of shoulder surgery in the BCP.

      INTERVENTION GROUPS This study will involve a single prospective cohort. Patients who meet
      the selection criteria will be recruited to the study following voluntary informed consent .
      Cerebral oxygenation will be measured by application of cerebral oximeters to each patients
      forehead.

      AIM OF THE STUDY This study has three aims; (i) To examine the relationship between cerebral
      desaturation during shoulder surgery in the BCP, and the incidence of POCD.

      (ii) To determine the variation in cerebral oxygenation recorded using randomised (for
      superior/inferior) simultaneous application of the INVOS™ and FORE-SIGHT® oximeters, during
      shoulder surgery in the beach chair position.

      (iii) Assess the relationships between cerebral oxygen desaturation during shoulder surgery
      in the BCP and variables including mean arterial pressure, incidence of nausea/vomiting,
      duration of hospital stay, BMI, hypertension and adverse events.

      RESEARCH QUESTION There are three research questions correlating with the three research
      aims; (i) Is cerebral desaturation during shoulder surgery associated with POCD? (ii) Do the
      FORE-SIGHT® and INVOS™ 5100 devices vary in their measurement of cerebral oxygenation during
      shoulder surgery in the BCP? (iii) Is there a relationship between cerebral desaturation
      events during shoulder surgery in the BCP and variables including mean arterial blood
      pressure, post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any
      adverse events?

      NULL HYPOTHESES The three null hypotheses are; (i) Cerebral desaturation as measured using
      cerebral oximetry is not related to POCD after shoulder surgery in the BCP.

      (ii) There is no significant difference between the INVOS™ 5100 and the FORE-SIGHT® monitors
      assessment of cerebral oxygenation during shoulder surgery in the BCP.

      (iii) There is no relationship between cerebral desaturation events during shoulder surgery
      in the BCP and variables including mean arterial blood pressure, the frequency of
      post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse
      events.

      PRIMARY HYPOTHESES The primary research hypotheses are; (i) Cerebral desaturation events
      during surgery in the BCP will be related to POCD.

      (ii) The INVOS™ 5100 and the FORE-SIGHT® monitors will show no significant difference in
      their ability to measure cerebral oxygenation.

      (iii) Cerebral desaturation events experienced during shoulder surgery in the BCP are related
      to a drop in mean arterial blood pressure, an increased likelihood of post-operative nausea
      and vomiting, greater length of hospital stay, a higher BMI, hypertension and greater
      frequency of adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Trail making test: Delis-Kaplan Executive Function System
time frame: Baseline
description: The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
measure: Trail making test: Delis-Kaplan Executive Function System
time frame: 1 day post-operative
description: The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
measure: Trail making test: Delis-Kaplan Executive Function System
time frame: 8-14 days post-operative
description: The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
measure: Trail making test: Delis-Kaplan Executive Function System
time frame: 6 weeks post-operative
description: The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
measure: Trail making test: Delis-Kaplan Executive Function System
time frame: 3 months post-operative
description: The D-KEFs Trails subtest has four trials; visual scanning, number sequencing, letter sequencing and letter number sequencing.
measure: Single letter verbal fluency
time frame: Baseline
description: This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
measure: Single letter verbal fluency
time frame: 1 day post-operative
description: This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
measure: Single letter verbal fluency
time frame: 8-14 days post-operative
description: This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
measure: Single letter verbal fluency
time frame: 6 weeks post-operative
description: This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
measure: Single letter verbal fluency
time frame: 3 months post-operative
description: This task requires the individual to spontaneously generate a list of words in 60 seconds, where the words cannot be name of places, people or other proper nouns.
measure: Rey Auditory Verbal Learning Test
time frame: Baseline
description: The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
measure: Rey Auditory Verbal Learning Test
time frame: 1 day post-operative
description: The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
measure: Rey Auditory Verbal Learning Test
time frame: 8-14 days post-operative
description: The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
measure: Rey Auditory Verbal Learning Test
time frame: 6 weeks post-operative
description: The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
measure: Rey Auditory Verbal Learning Test
time frame: 3 months post-operative
description: The RAVLT assesses immediate and delayed auditory memory recall and recognition. The task consists of 15 nouns learned over 5 trials with a free recall after each presentation. The order of presentation remaining fixed across trials (List A). At the end of the 5th trial an interference list of 15 words is presented (List B), following a free recall of that list. Immediately after this, delayed recall of the first list is tested. Following a 20-minute delay, delayed recall and recognition of the first word list is assessed.
measure: Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
time frame: Baseline
description: The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
measure: Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
time frame: 1 day post-operative
description: The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
measure: Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
time frame: 8-14 days post-operative
description: The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
measure: Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
time frame: 6 weeks post-operative
description: The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
measure: Letter-Number Sequencing (from Wechsler Adult Intelligence Scale, 4th edition)
time frame: 3 months post-operative
description: The examinee is verbally presented with a combination of numbers and letters or increasing amounts. The examinee is required to recall the numbers in ascending order then letters in alphabetical order.
measure: Cerebral desaturation events (INVOS)
time frame: Intra-operative
description: Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.
measure: Cerebral desaturation events (FORE-SIGHT)
time frame: Intra-operative
description: Cerebral desaturation will be defined as a decrease in regional cerebral oxygen saturation greater than, or equal to 20% from baseline or a fall below 50% absolute.
measure: Mean arterial pressure
time frame: Intra-operative
description: Mean arterial blood pressure (mmHg)
measure: Body Mass Index
time frame: Baseline
description: Patient Body Mass Index (BMI)
measure: Hypertension
time frame: Baseline
description: Patient-reported hypertension
measure: Nausea and vomiting within 48 hours
time frame: 1 day, 8-14 days
description: Patient-reported nausea and vomiting
measure: Duration of hospital stay
time frame: 8-14 days
description: Patient duration of hospital stay
measure: Adverse events
time frame: Intra-operative
description: Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment stage and recorded on a data collection form.
measure: Adverse events
time frame: 1 day
description: Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
measure: Adverse events
time frame: 8-14 days
description: Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
measure: Adverse events
time frame: 6 weeks
description: Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
measure: Adverse events
time frame: 3 months
description: Any adverse events arising during the trial will be closely monitored and followed up until the resolution of symptoms. These will be checked at each assessment
measure: Depression Anxiety and Stress Scale-21
time frame: Baseline, 1 day, 8-14 days, 6 weeks, 3 months
description: The DASS-21 has 21 questions that index the level of depression, anxiety and stress an individual has experienced in the preceding week.
measure: Social Relationships and Support Scale
time frame: Baseline, 1 day, 8-14 days, 6 weeks, 3 months
description: The social support measures address the issues of social process in a range different clinical populations.
measure: Loneliness Scale
time frame: Baseline, 1 day, 8-14 days, 6 weeks, 3 months
description: A standardised 3-item Loneliness scale, comprised of items from the well-validated University of California, Los Angeles (UCLA) Loneliness scale.
arm group label: Surgery patients
arm group type: Experimental
description: Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.
intervention type: Device
intervention name: Dual-monitoring
description: Monitored using both INVOS and FORE-SIGHT monitors.
arm group label: Surgery patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Mark Ross, MBBS
role: Principal Investigator
affiliation: Director
last name: Silvia Manzanero, PhD
phone: +61 7 3834 7069
email: researchmanager@upperlimb.com
last name: Mark Ross, MBBS
phone: +61 7 3834 6592
email: markross@upperlimb.com
facility: 
status: Recruiting
contact: 
country: Australia
url: http://www.upperlimb.com
description: Brisbane Hand and Upper Limb Research Institute
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: Deidentified cerebral oximeter data acquisition files will be made available to the equipment manufacturers (Medtronic, CASMED) at the conclusion of the study.
provided document: 