<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/NCT02198183</url>
  </required_header>
  <id_info>
    <org_study_id>2014-003</org_study_id>
    <nct_id>NCT02198183</nct_id>
  </id_info>
  <brief_title>Total Shoulder Arthroplasty Near-infrared Spectroscopy</brief_title>
  <acronym>TSA NIRS</acronym>
  <official_title>The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure cerebral oxygenation and cardiac output of total&#xD;
      shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure&#xD;
      ventilation (PPV).&#xD;
&#xD;
      We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare&#xD;
      during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is&#xD;
      well maintained under GA in the sitting position when epinephrine is used, but that decreased&#xD;
      cardiac output increases the risk of cerebral desaturation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Cerebral Desaturation Events</measure>
    <time_frame>Day of surgery</time_frame>
    <description>The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of &gt;20% from baseline that lasts for 90 seconds or longer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac Output (CO)</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Cardiac output of patients as measured in liters per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Index (CI)</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Volume (SV)</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Pressure (MAP)</measure>
    <time_frame>Day of surgery</time_frame>
    <description>mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End Tidal Carbon Dioxide (ETCO2)</measure>
    <time_frame>Day of surgery</time_frame>
    <description>a lower score is a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intravenous Fluid Volume</measure>
    <time_frame>Day of surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Cerebral Ischemia</condition>
  <arm_group>
    <arm_group_label>Near-infrared spectroscopy</arm_group_label>
    <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Casmed Fore-Sight Elite</intervention_name>
    <arm_group_label>Near-infrared spectroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-invasive Cardiac Output Monitor (NICOM)</intervention_name>
    <arm_group_label>Near-infrared spectroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special&#xD;
        Surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18-99 undergoing total shoulder arthroplasty&#xD;
&#xD;
          -  Planned general anesthesia + brachial plexus nerve block&#xD;
&#xD;
          -  Planned arterial catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years older and older than 99&#xD;
&#xD;
          -  Patients not intending to receive general anesthesia and peripheral nerve block&#xD;
&#xD;
          -  Indication for endotracheal tube&#xD;
&#xD;
          -  BMI ≥ 30&#xD;
&#xD;
          -  Ejection Fraction (if known) &lt; 50%&#xD;
&#xD;
          -  Known significant restrictive or obstructive pulmonary disease&#xD;
&#xD;
          -  Patients with a history of transient ischemic attack (TIA) or stroke&#xD;
&#xD;
          -  Patients with recent signs or symptoms of myocardial ischemia&#xD;
&#xD;
               -  Current stress test positive for ischemia&#xD;
&#xD;
          -  Intolerance to study medications&#xD;
&#xD;
          -  pre-existing contraindication to regional anesthesia&#xD;
&#xD;
               -  infection at block site&#xD;
&#xD;
               -  pre-existing neurological injury to operative limb&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques T YaDeau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Friedman DJ, Parnes NZ, Zimmer Z, Higgins LD, Warner JJ. Prevalence of cerebrovascular events during shoulder surgery and association with patient position. Orthopedics. 2009 Apr;32(4):orthosupersite.com/view.asp?rID=38058.</citation>
    <PMID>19388618</PMID>
  </reference>
  <reference>
    <citation>Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, John R, Shaw PM, Wilfred SE, Stanton M. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):430-5. doi: 10.1097/AAP.0b013e318228d54e.</citation>
    <PMID>21857267</PMID>
  </reference>
  <reference>
    <citation>Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.</citation>
    <PMID>21866430</PMID>
  </reference>
  <reference>
    <citation>Koh JL, Levin SD, Chehab EL, Murphy GS. Neer Award 2012: cerebral oxygenation in the beach chair position: a prospective study on the effect of general anesthesia compared with regional anesthesia and sedation. J Shoulder Elbow Surg. 2013 Oct;22(10):1325-31. doi: 10.1016/j.jse.2013.01.035. Epub 2013 Apr 6.</citation>
    <PMID>23571083</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <results_first_submitted>April 12, 2022</results_first_submitted>
  <results_first_submitted_qc>April 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 17, 2023</results_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</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>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Near-infrared Spectroscopy</title>
          <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients that were enrolled and not excluded due to receiving an intra-operative endotracheal tube or missing data from the monitors or instruments used.</population>
      <group_list>
        <group group_id="B1">
          <title>Near-infrared Spectroscopy</title>
          <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Cerebral Desaturation Events</title>
        <description>The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of &gt;20% from baseline that lasts for 90 seconds or longer.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Near-infrared Spectroscopy</title>
            <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cerebral Desaturation Events</title>
          <description>The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of &gt;20% from baseline that lasts for 90 seconds or longer.</description>
          <units>Number of CDE Incidences</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Output (CO)</title>
        <description>Cardiac output of patients as measured in liters per minute</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Near-infrared Spectroscopy</title>
            <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Output (CO)</title>
          <description>Cardiac output of patients as measured in liters per minute</description>
          <units>liters per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Index (CI)</title>
        <description>Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Near-infrared Spectroscopy</title>
            <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Index (CI)</title>
          <description>Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size.</description>
          <units>L/min/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stroke Volume (SV)</title>
        <description>Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Near-infrared Spectroscopy</title>
            <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
          </group>
        </group_list>
        <measure>
          <title>Stroke Volume (SV)</title>
          <description>Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.</description>
          <units>milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Arterial Pressure (MAP)</title>
        <description>mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Near-infrared Spectroscopy</title>
            <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Arterial Pressure (MAP)</title>
          <description>mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GA without PPV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GA with PPV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>End Tidal Carbon Dioxide (ETCO2)</title>
        <description>a lower score is a better outcome.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Near-infrared Spectroscopy</title>
            <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
          </group>
        </group_list>
        <measure>
          <title>End Tidal Carbon Dioxide (ETCO2)</title>
          <description>a lower score is a better outcome.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GA without PPV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GA with PPV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intravenous Fluid Volume</title>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Near-infrared Spectroscopy</title>
            <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
          </group>
        </group_list>
        <measure>
          <title>Intravenous Fluid Volume</title>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1408" spread="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Near-infrared Spectroscopy</title>
          <description>Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)&#xD;
Casmed Fore-Sight Elite&#xD;
Non-invasive Cardiac Output Monitor (NICOM)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Jacques Yadeau</name_or_title>
      <organization>Hospital for Special Surgery, Anesthesiology</organization>
      <phone>2126061036</phone>
      <email>Yadeauj@hss.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02198183
org study id: 2014-003
nct id: NCT02198183
lead sponsor: 
has dmc: No
The purpose of this study is to measure cerebral oxygenation and cardiac output of total
      shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure
      ventilation (PPV).

      We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare
      during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is
      well maintained under GA in the sitting position when epinephrine is used, but that decreased
      cardiac output increases the risk of cerebral desaturation.
observational model: Cohort
time perspective: Prospective
measure: Number of Cerebral Desaturation Events
time frame: Day of surgery
description: The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of >20% from baseline that lasts for 90 seconds or longer.
measure: Cardiac Output (CO)
time frame: Day of surgery
description: Cardiac output of patients as measured in liters per minute
measure: Cardiac Index (CI)
time frame: Day of surgery
description: Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size.
measure: Stroke Volume (SV)
time frame: Day of surgery
description: Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.
measure: Mean Arterial Pressure (MAP)
time frame: Day of surgery
description: mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.
measure: End Tidal Carbon Dioxide (ETCO2)
time frame: Day of surgery
description: a lower score is a better outcome.
measure: Intravenous Fluid Volume
time frame: Day of surgery
arm group label: Near-infrared spectroscopy
description: Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM)
intervention type: Device
intervention name: Casmed Fore-Sight Elite
arm group label: Near-infrared spectroscopy
intervention type: Device
intervention name: Non-invasive Cardiac Output Monitor (NICOM)
arm group label: Near-infrared spectroscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacques T YaDeau, MD, PhD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
citation: Friedman DJ, Parnes NZ, Zimmer Z, Higgins LD, Warner JJ. Prevalence of cerebrovascular events during shoulder surgery and association with patient position. Orthopedics. 2009 Apr;32(4):orthosupersite.com/view.asp?rID=38058.
PMID: 19388618
citation: Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, John R, Shaw PM, Wilfred SE, Stanton M. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):430-5. doi: 10.1097/AAP.0b013e318228d54e.
PMID: 21857267
citation: Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
PMID: 21866430
citation: Koh JL, Levin SD, Chehab EL, Murphy GS. Neer Award 2012: cerebral oxygenation in the beach chair position: a prospective study on the effect of general anesthesia compared with regional anesthesia and sedation. J Shoulder Elbow Surg. 2013 Oct;22(10):1325-31. doi: 10.1016/j.jse.2013.01.035. Epub 2013 Apr 6.
PMID: 23571083
responsible party type: Sponsor
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Ischemia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 