<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/NCT02246036</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00989-38</org_study_id>
    <nct_id>NCT02246036</nct_id>
  </id_info>
  <brief_title>Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation</brief_title>
  <acronym>MC Monitor</acronym>
  <official_title>Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Perfusion Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CEISO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Advanced Perfusion Diagnostics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very&#xD;
      common complication yielding high morbidity and mortality. Inadequate regional perfusion of&#xD;
      certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS.&#xD;
      Current practice uses cardiac output data and blood pressure to manage shock but there are&#xD;
      still lacks of information about the regional perfusion. This leads to late MODS diagnostics&#xD;
      preventing the implementation of adequate treatment.&#xD;
&#xD;
      Gut perfusion monitoring seems to be a good target to assess the microcirculation but,&#xD;
      nowadays, no practical methods or devices are available to measure the gut perfusion, and the&#xD;
      current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).&#xD;
&#xD;
      &quot;MC Monitor&quot; trial is a prospective, multi-center pilot study, enrolling 10 patients.&#xD;
&#xD;
      The probe will be used by intensivists on ICU patients with a risk of shock and requiring&#xD;
      mechanical ventilation.&#xD;
&#xD;
      The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist&#xD;
      (standard procedure for post-pyloric tubes placement). This procedure will be used to assess&#xD;
      the status of the gut mucosa prior to the placement of the APD probe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of duodenal lesions</measure>
    <time_frame>24 hours</time_frame>
    <description>Duodenal lesions are defined as visible alterations of the duodenum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Signal-to-noise ratio of the APD probe</measure>
    <time_frame>24 hours</time_frame>
    <description>The signal is a reflect of the pulsatile flow in the duodenum. This assertion is evaluated thanks to a signal-to-noise ratio of the cardiac frequency in the PPG on other non-filtered signal componants.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Multiple Organ Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>APD probe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placement of a duodenal probe during 24 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>APD probe</intervention_name>
    <description>The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).</description>
    <arm_group_label>APD probe</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or more,&#xD;
&#xD;
          -  Male or female,&#xD;
&#xD;
          -  ICU patient, on vasoactive amines, under mechanical ventilation,&#xD;
&#xD;
          -  Stable hemodynamic status,&#xD;
&#xD;
          -  Life expectancy expected to exceed 72 hours,&#xD;
&#xD;
          -  Length of ICU stay greater than 5 days,&#xD;
&#xD;
          -  Willing to participate and signed informed consent,&#xD;
&#xD;
          -  Affiliation to the French social security system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating woman,&#xD;
&#xD;
          -  Ongoing enteral nutrition,&#xD;
&#xD;
          -  Risk of gastrointestinal ischemia,&#xD;
&#xD;
          -  History of pharyngeal surgery surgery, esophageal surgery, radiotherapy of mediastinal&#xD;
             area,&#xD;
&#xD;
          -  Known ear-nose-throat malignant disease,&#xD;
&#xD;
          -  Unexplored dysphagia,&#xD;
&#xD;
          -  Known recent gastrointestinal suture,&#xD;
&#xD;
          -  Esophageal varices,&#xD;
&#xD;
          -  Abdominal pain,&#xD;
&#xD;
          -  Unstable cervical fracture,&#xD;
&#xD;
          -  Moribund patient,&#xD;
&#xD;
          -  Active participation in another investigational protocol within the past 30 days,&#xD;
&#xD;
          -  Subject legally protected, under legal guardianship, deprived of his/her liberty by&#xD;
             judicial or administrative decision.&#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>Bernard Allaouchiche, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Estaing - Service réanimation adultes</name>
      <address>
        <city>Clermont-ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon-Sud</name>
      <address>
        <city>Lyon</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHU Caremeau - Unité REA</name>
      <address>
        <city>Nimes</city>
        <zip>30900</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</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>Multiple Organ Failure</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/NCT02246036
org study id: 2014-A00989-38
nct id: NCT02246036
lead sponsor: 
collaborator: 
has dmc: No
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very
      common complication yielding high morbidity and mortality. Inadequate regional perfusion of
      certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS.
      Current practice uses cardiac output data and blood pressure to manage shock but there are
      still lacks of information about the regional perfusion. This leads to late MODS diagnostics
      preventing the implementation of adequate treatment.

      Gut perfusion monitoring seems to be a good target to assess the microcirculation but,
      nowadays, no practical methods or devices are available to measure the gut perfusion, and the
      current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).

      "MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.

      The probe will be used by intensivists on ICU patients with a risk of shock and requiring
      mechanical ventilation.

      The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist
      (standard procedure for post-pyloric tubes placement). This procedure will be used to assess
      the status of the gut mucosa prior to the placement of the APD probe.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absence of duodenal lesions
time frame: 24 hours
description: Duodenal lesions are defined as visible alterations of the duodenum.
measure: Signal-to-noise ratio of the APD probe
time frame: 24 hours
description: The signal is a reflect of the pulsatile flow in the duodenum. This assertion is evaluated thanks to a signal-to-noise ratio of the cardiac frequency in the PPG on other non-filtered signal componants.
arm group label: APD probe
arm group type: Experimental
description: Placement of a duodenal probe during 24 hours.
intervention type: Device
intervention name: APD probe
description: The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).
arm group label: APD probe
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bernard Allaouchiche, Prof.
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Organ Failure