<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/NCT04439604</url>
  </required_header>
  <id_info>
    <org_study_id>NOWOBILSKI 2019</org_study_id>
    <nct_id>NCT04439604</nct_id>
  </id_info>
  <brief_title>Impact of Body Mass Index on Positive End-expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anaesthesia</brief_title>
  <acronym>PEPTI</acronym>
  <official_title>Impact of Body Mass Index on Positive End-Expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anesthesia: A Retrospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      The induction of general anaesthesia is associated with a fall in lung volume due in&#xD;
      particular to a decrease in muscle tone and the formation of denitrogenation atelectasis.&#xD;
      Many recent studies insist on the need to apply a so-called &quot;protective&quot; strategy of&#xD;
      intraoperative ventilation, which combines the use of recruitment manoeuvres, reduced tidal&#xD;
      volume (Vt) (6-8ml/kg) and positive expiratory pressure (PEEP) to prevent these phenomena.&#xD;
      However, the setting of PEEP remains debated and several authors agree on the need to&#xD;
      individualize ventilatory parameters, particularly in obese patients, without describing the&#xD;
      individualization tools.&#xD;
&#xD;
      In the ICU, it has been shown that electrical impedance tomography (EIT) can be used to&#xD;
      individualise the PEEP level in a simple and non-invasive way. Therefore, we wish to&#xD;
      determine whether the use of this technique during general anaesthesia allows for the&#xD;
      individualization of PEEP, and whether the value determined is correlated with the body mass&#xD;
      index (BMI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2018</start_date>
  <completion_date type="Actual">December 6, 2019</completion_date>
  <primary_completion_date type="Actual">July 6, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>electrical impedance tomography</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>General Anesthetic</condition>
  <condition>Positive Expiratory Pressure</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>patient undergoing surgery under general anaesthesia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>regional ventilation monitoring</intervention_name>
    <description>regional ventilation monitoring</description>
    <arm_group_label>patient undergoing surgery under general anaesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surgical Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient&#xD;
&#xD;
          -  Patient who received general anesthesia with orotracheal intubation.&#xD;
&#xD;
          -  Patient who has undergone surgery of the following types: : abdominal surgery by&#xD;
             laparotomy or laparoscopy, emergency or scheduled&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04439604
org study id: NOWOBILSKI 2019
nct id: NCT04439604
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The induction of general anaesthesia is associated with a fall in lung volume due in
      particular to a decrease in muscle tone and the formation of denitrogenation atelectasis.
      Many recent studies insist on the need to apply a so-called "protective" strategy of
      intraoperative ventilation, which combines the use of recruitment manoeuvres, reduced tidal
      volume (Vt) (6-8ml/kg) and positive expiratory pressure (PEEP) to prevent these phenomena.
      However, the setting of PEEP remains debated and several authors agree on the need to
      individualize ventilatory parameters, particularly in obese patients, without describing the
      individualization tools.

      In the ICU, it has been shown that electrical impedance tomography (EIT) can be used to
      individualise the PEEP level in a simple and non-invasive way. Therefore, we wish to
      determine whether the use of this technique during general anaesthesia allows for the
      individualization of PEEP, and whether the value determined is correlated with the body mass
      index (BMI).
observational model: Cohort
time perspective: Retrospective
measure: electrical impedance tomography
time frame: Through study completion, an average of 1 year
arm group label: patient undergoing surgery under general anaesthesia
intervention type: Other
intervention name: regional ventilation monitoring
description: regional ventilation monitoring
arm group label: patient undergoing surgery under general anaesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor