<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/NCT03753217</url>
  </required_header>
  <id_info>
    <org_study_id>2016/57</org_study_id>
    <nct_id>NCT03753217</nct_id>
  </id_info>
  <brief_title>Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Intravenous Anesthesia</brief_title>
  <acronym>Bis-qCON-IV</acronym>
  <official_title>Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two&#xD;
      outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide&#xD;
      information about the depth of the hypnotic state, similar to that provided by the BIS™.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>qCON monitoring during maintenance of anesthesia</measure>
    <time_frame>Up to 10 hours</time_frame>
    <description>Measurement of qCON values during maintenance of anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BIS monitoring during maintenance of anesthesia</measure>
    <time_frame>Up to 10 hours</time_frame>
    <description>Measurement of BIS values during maintenance of anesthesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>qCON monitoring during induction of anesthesia</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of qCON values during induction of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS monitoring during induction of anesthesia</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of BIS values during induction of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>qCON monitoring during recovery of anesthesia</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of qCON values during recovery of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS monitoring during recovery of anesthesia</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of BIS values during recovery of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burst Suppression ratio retrieved by qCON monitoring</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of Burst Suppression ratio values during anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burst Suppression ratio retrieved by BIS monitoring</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of Burst Suppression ratio values during anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>qNOX monitoring during anesthesia</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of qNOX values during anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periods of loss of signal of qCON</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of qCON values during anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periods of loss of signal of BIS</measure>
    <time_frame>One day</time_frame>
    <description>Measurement of BIS values during anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative memorising</measure>
    <time_frame>One day</time_frame>
    <description>Questionnaire for assessment of memorising of surgery by the patient</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>qCON Monitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Simultaneous measurement of BIS and qCON</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>qCON Monitor</intervention_name>
    <description>supervision by qCON monitor of the depth of anesthesia</description>
    <arm_group_label>qCON Monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients above 18 years,&#xD;
&#xD;
          -  Patients affiliated to a national insurance scheme or benefiting from such a program,&#xD;
&#xD;
          -  Patients having given their written consent,&#xD;
&#xD;
          -  Patients that must benefit from a general anesthesia by intravenous drugs (propofol&#xD;
             and remifentanil),&#xD;
&#xD;
          -  For the patients taken care in ambulatory surgery, having a telephone and agreeing to&#xD;
             communicate their phone number.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding Women,&#xD;
&#xD;
          -  Patients having a limit of use of the Bispectral Index (BIS) or qCON monitors,&#xD;
&#xD;
          -  Patients having a contraindication to Propofol and/or to Remifentanil.&#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>Marc Fischler, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anesthesia Monitoring</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03753217
org study id: 2016/57
nct id: NCT03753217
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two
      outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide
      information about the depth of the hypnotic state, similar to that provided by the BIS™.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: qCON monitoring during maintenance of anesthesia
time frame: Up to 10 hours
description: Measurement of qCON values during maintenance of anesthesia
measure: BIS monitoring during maintenance of anesthesia
time frame: Up to 10 hours
description: Measurement of BIS values during maintenance of anesthesia
measure: qCON monitoring during induction of anesthesia
time frame: One day
description: Measurement of qCON values during induction of anesthesia
measure: BIS monitoring during induction of anesthesia
time frame: One day
description: Measurement of BIS values during induction of anesthesia
measure: qCON monitoring during recovery of anesthesia
time frame: One day
description: Measurement of qCON values during recovery of anesthesia
measure: BIS monitoring during recovery of anesthesia
time frame: One day
description: Measurement of BIS values during recovery of anesthesia
measure: Burst Suppression ratio retrieved by qCON monitoring
time frame: One day
description: Measurement of Burst Suppression ratio values during anesthesia
measure: Burst Suppression ratio retrieved by BIS monitoring
time frame: One day
description: Measurement of Burst Suppression ratio values during anesthesia
measure: qNOX monitoring during anesthesia
time frame: One day
description: Measurement of qNOX values during anesthesia
measure: Periods of loss of signal of qCON
time frame: One day
description: Measurement of qCON values during anesthesia
measure: Periods of loss of signal of BIS
time frame: One day
description: Measurement of BIS values during anesthesia
measure: Intraoperative memorising
time frame: One day
description: Questionnaire for assessment of memorising of surgery by the patient
arm group label: qCON Monitor
arm group type: Experimental
description: Simultaneous measurement of BIS and qCON
intervention type: Device
intervention name: qCON Monitor
description: supervision by qCON monitor of the depth of anesthesia
arm group label: qCON Monitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Fischler, MD PhD
role: Study Director
affiliation: Hopital Foch
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No