<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/NCT04432480</url>
  </required_header>
  <id_info>
    <org_study_id>2019_31</org_study_id>
    <secondary_id>2020-A00059-30</secondary_id>
    <nct_id>NCT04432480</nct_id>
  </id_info>
  <brief_title>NIPE Monitoring Values During Routine Pediatric Anesthesia</brief_title>
  <acronym>OMNIPED</acronym>
  <official_title>Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation Apicil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      Description of the standard values and fluctuations of the new NIPE index during routine&#xD;
      pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous&#xD;
      value ranging from 0 to 100. NIPE values described at different time points during&#xD;
      anesthesia: beginning of induction, intubation, extubation, skin incision, opioid&#xD;
      administration, vasopressors or atropine administration, transfusion, volume expansion. In&#xD;
      addition, NIPE values during hemodynamic events (heart rate or blood pressure increase&#xD;
      greater than 20%) will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Variation of the instantaneous NIPE index after opioid administration</measure>
    <time_frame>5 minutes after opioid administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the area under the ROC curve of NIPE value</measure>
    <time_frame>Baseline and 5 minutes before the first hemodynamic event.</time_frame>
    <description>the NIPE value is definied by the predictibility of a hemodynamic event : 20% increase in Baseline heart rate, blood pressure and NIPE values recorded just before skin incision</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of the instantaneous NIPE index after skin incision</measure>
    <time_frame>5 minutes after skin incision</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of the instantaneous NIPE index after insertion of airway control device</measure>
    <time_frame>5 minutes after insertion of airway control device</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of the instantaneous NIPE index after removal of airway control device</measure>
    <time_frame>5 minutes after removal of airway control device</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of the instantaneous NIPE index after anesthetic induction</measure>
    <time_frame>5 minutes after anesthetic induction</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Anesthesia</condition>
  <condition>Nociceptive Pain</condition>
  <arm_group>
    <arm_group_label>Children</arm_group_label>
    <description>0-15 years old children undergoing surgery under general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NIPE (Newborn Infant Parasympathetic Evaluation) monitoring</intervention_name>
    <description>Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.</description>
    <arm_group_label>Children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children in the pediatric surgical wardof:&#xD;
&#xD;
          -  Lille University hospital (Lille, France)&#xD;
&#xD;
          -  Armand Trousseau Hospital (Paris, France)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgery under general anesthesia&#xD;
&#xD;
          -  Absence of analgesic treatment in the 24 hours before the intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Central or peripheral neuropathy&#xD;
&#xD;
          -  Non sinus arrythmia, pace maker&#xD;
&#xD;
          -  Cardiac surgery&#xD;
&#xD;
          -  Analgesic medication within 24 hours before surgery&#xD;
&#xD;
          -  Anti cholinergic or anti arrythmic chronic medication&#xD;
&#xD;
          -  Opposition of the legal tutor or of the child&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne LAFFARGUE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hop Jeanne de Flandre Chu Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>General anesthesia</keyword>
  <keyword>Nociceptive Pain</keyword>
  <keyword>Monitoring</keyword>
  <keyword>Pediatric anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nociceptive Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT04432480
org study id: 2019_31
secondary id: 2020-A00059-30
nct id: NCT04432480
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Description of the standard values and fluctuations of the new NIPE index during routine
      pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous
      value ranging from 0 to 100. NIPE values described at different time points during
      anesthesia: beginning of induction, intubation, extubation, skin incision, opioid
      administration, vasopressors or atropine administration, transfusion, volume expansion. In
      addition, NIPE values during hemodynamic events (heart rate or blood pressure increase
      greater than 20%) will be recorded.
observational model: Case-Only
time perspective: Prospective
measure: Variation of the instantaneous NIPE index after opioid administration
time frame: 5 minutes after opioid administration
measure: the area under the ROC curve of NIPE value
time frame: Baseline and 5 minutes before the first hemodynamic event.
description: the NIPE value is definied by the predictibility of a hemodynamic event : 20% increase in Baseline heart rate, blood pressure and NIPE values recorded just before skin incision
measure: Variation of the instantaneous NIPE index after skin incision
time frame: 5 minutes after skin incision
measure: Variation of the instantaneous NIPE index after insertion of airway control device
time frame: 5 minutes after insertion of airway control device
measure: Variation of the instantaneous NIPE index after removal of airway control device
time frame: 5 minutes after removal of airway control device
measure: Variation of the instantaneous NIPE index after anesthetic induction
time frame: 5 minutes after anesthetic induction
arm group label: Children
description: 0-15 years old children undergoing surgery under general anesthesia
intervention type: Procedure
intervention name: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring
description: Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.
arm group label: Children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Years
healthy volunteers: No
last name: Anne LAFFARGUE, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Nociceptive Pain