<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/NCT02240368</url>
  </required_header>
  <id_info>
    <org_study_id>A01</org_study_id>
    <nct_id>NCT02240368</nct_id>
  </id_info>
  <brief_title>Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery</brief_title>
  <official_title>Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Foggia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Foggia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors&#xD;
      agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in&#xD;
      relationship with the age in the pediatric surgery setting.&#xD;
&#xD;
      Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established&#xD;
      in adult general anesthesia.&#xD;
&#xD;
      Their utility is yet undefined in the pediatric population as age seems to affect their&#xD;
      ability to track the cerebral hypnotic state in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients monitored applying standard device for blood pressure, electrocardiogram and&#xD;
      pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA&#xD;
      monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators&#xD;
      will not assign any specific interventions to the subjects of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>BISPECTRAL Index</measure>
    <time_frame>BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours</time_frame>
    <description>The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.&#xD;
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Entropy</measure>
    <time_frame>Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours</time_frame>
    <description>The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.&#xD;
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BISPECTRAL Index Awaking</measure>
    <time_frame>reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia</time_frame>
    <description>In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Entropy Awaking</measure>
    <time_frame>reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia</time_frame>
    <description>In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Anesthesia</condition>
  <condition>Child</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Children age between 1 month to 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Children age between 13 months and 36 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Children age between 37 months to 144 months</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and&#xD;
        mechanical ventilation for elective surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  physical status classification (ASA) I - II&#xD;
&#xD;
          -  general balanced anesthesia&#xD;
&#xD;
          -  mechanically ventilated with laryngeal mask&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe developmental delay&#xD;
&#xD;
          -  neurological disorders or receiving treatment with antiepileptic or stimulant&#xD;
&#xD;
          -  patients with preexisting lung or cardiac disease&#xD;
&#xD;
          -  airway abnormalities&#xD;
&#xD;
          -  marked skin sensitivity and conditions where the placement of the BIS and Entropy&#xD;
             sensor or process of assessment would interfere with the surgery procedure.&#xD;
&#xD;
          -  patients receiving local anaesthesia, regional block combined with general anaesthesia&#xD;
&#xD;
          -  sedation administered by non anesthesiologists for invasive and noninvasive diagnostic&#xD;
             or therapeutic procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele Dambrosio, Medic</last_name>
    <role>Study Chair</role>
    <affiliation>University of Foggia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gilda Cinnella, Medic</last_name>
    <role>Study Director</role>
    <affiliation>University of Foggia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Sciusco, medic</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Foggia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pasquale Raimondo, Medic</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Foggia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedali Riuniti</name>
      <address>
        <city>Foggia</city>
        <state>FG</state>
        <zip>70100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.anestesia.unifg.it/</url>
    <description>Speciality school of anesthesia of University of Foggia</description>
  </link>
  <link>
    <url>http://www.unifg.it/</url>
    <description>University of Foggia</description>
  </link>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>May 24, 2015</results_first_submitted>
  <results_first_submitted_qc>June 12, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 9, 2015</results_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Foggia</investigator_affiliation>
    <investigator_full_name>Alberto Sciusco</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>Depth anesthesia monitors</keyword>
  <keyword>Children anesthesia</keyword>
  <keyword>Bispectral monitor</keyword>
  <keyword>Entropy monitor</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1</title>
          <description>Children age between 1 month to 12 months</description>
        </group>
        <group group_id="P2">
          <title>Group 2</title>
          <description>Children age between 13 months and 36 months</description>
        </group>
        <group group_id="P3">
          <title>Group 3</title>
          <description>Children age between 37 months to 144 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Surgery lasted less then 20 minutes</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Entropy failed to detect more than 50%</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>Children age between 1 month to 12 months</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>Children age between 13 months and 36 months</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>Children age between 37 months to 144 months</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="48"/>
          </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="8"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.63" spread="3.7"/>
                    <measurement group_id="B2" value="24.95" spread="8.0"/>
                    <measurement group_id="B3" value="82.22" spread="33.8"/>
                    <measurement group_id="B4" value="43.38" spread="37.56"/>
                  </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="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </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>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>BISPECTRAL Index</title>
        <description>The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.&#xD;
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.</description>
        <time_frame>BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Children age between 1 month to 12 months</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Children age between 13 months and 36 months</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Children age between 37 months to 144 months</description>
          </group>
        </group_list>
        <measure>
          <title>BISPECTRAL Index</title>
          <description>The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.&#xD;
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.57" upper_limit="0.61"/>
                    <measurement group_id="O2" value="0.66" lower_limit="0.64" upper_limit="0.67"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.71" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>bootstrap</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Entropy</title>
        <description>The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.&#xD;
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.</description>
        <time_frame>Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Children age between 1 month to 12 months</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Children age between 13 months and 36 months</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Children age between 37 months to 144 months</description>
          </group>
        </group_list>
        <measure>
          <title>Entropy</title>
          <description>The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.&#xD;
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" lower_limit="0.62" upper_limit="0.65"/>
                    <measurement group_id="O2" value="0.66" lower_limit="0.65" upper_limit="0.68"/>
                    <measurement group_id="O3" value="0.72" lower_limit="0.71" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>bootstrap</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BISPECTRAL Index Awaking</title>
        <description>In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer</description>
        <time_frame>reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Children age between 1 month to 12 months</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Children age between 13 months and 36 months</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Children age between 37 months to 144 months</description>
          </group>
        </group_list>
        <measure>
          <title>BISPECTRAL Index Awaking</title>
          <description>In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="62" upper_limit="78"/>
                    <measurement group_id="O2" value="86" lower_limit="77" upper_limit="92"/>
                    <measurement group_id="O3" value="81" lower_limit="74" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Entropy Awaking</title>
        <description>In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer</description>
        <time_frame>reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Children age between 1 month to 12 months</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Children age between 13 months and 36 months</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Children age between 37 months to 144 months</description>
          </group>
        </group_list>
        <measure>
          <title>Entropy Awaking</title>
          <description>In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" lower_limit="49" upper_limit="71"/>
                    <measurement group_id="O2" value="96" lower_limit="93" upper_limit="98"/>
                    <measurement group_id="O3" value="86" lower_limit="78" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Whole period of study from January 2014 to November 2014</time_frame>
      <desc>No adverse events were expected. No adverse events were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>Children age between 1 month to 12 months</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>Children age between 13 months and 36 months</description>
        </group>
        <group group_id="E3">
          <title>Group 3</title>
          <description>Children age between 37 months to 144 months</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Alberto Sciusco</name_or_title>
      <organization>University of Foggia</organization>
      <email>alberto.sciusco@gmail.com</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/NCT02240368
org study id: A01
nct id: NCT02240368
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors
      agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in
      relationship with the age in the pediatric surgery setting.

      Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established
      in adult general anesthesia.

      Their utility is yet undefined in the pediatric population as age seems to affect their
      ability to track the cerebral hypnotic state in children.
All patients monitored applying standard device for blood pressure, electrocardiogram and
      pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA
      monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators
      will not assign any specific interventions to the subjects of the study.
observational model: Cohort
time perspective: Prospective
measure: BISPECTRAL Index
time frame: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
description: The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.
measure: Entropy
time frame: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
description: The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.
measure: BISPECTRAL Index Awaking
time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
description: In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer
measure: Entropy Awaking
time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
description: In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer
arm group label: Group 1
description: Children age between 1 month to 12 months
arm group label: Group 2
description: Children age between 13 months and 36 months
arm group label: Group 3
description: Children age between 37 months to 144 months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Years
healthy volunteers: No
last name: Michele Dambrosio, Medic
role: Study Chair
affiliation: University of Foggia
last name: Gilda Cinnella, Medic
role: Study Director
affiliation: University of Foggia
last name: Alberto Sciusco, medic
role: Principal Investigator
affiliation: University of Foggia
last name: Pasquale Raimondo, Medic
role: Principal Investigator
affiliation: University of Foggia
facility: 
country: Italy
url: http://www.anestesia.unifg.it/
description: Speciality school of anesthesia of University of Foggia
url: http://www.unifg.it/
description: University of Foggia
responsible party type: Principal Investigator
investigator affiliation: University of Foggia
investigator full name: Alberto Sciusco
investigator title: Medical doctor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 