<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/NCT03809832</url>
  </required_header>
  <id_info>
    <org_study_id>2018/363/OB</org_study_id>
    <nct_id>NCT03809832</nct_id>
  </id_info>
  <brief_title>Microbiologic Contamination of Home Non Invasive Ventilators</brief_title>
  <acronym>MiCONIV</acronym>
  <official_title>Microbiologic Contamination of Home Non Invasive Ventilators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ADIR Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Home non-invasive ventilators are daily used by patients with chronic respiratory failure.&#xD;
      There are frequently used with warming and humidifying systems. These systems need to be&#xD;
      cared for and frequently washed by the patient.&#xD;
&#xD;
      The aim of this study is to evaluate if the humidifying system of home ventilators are&#xD;
      colonized by microbiological germs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of non-invasive ventilators is common for treating respiratory failure. Their care&#xD;
      relies on the patients and their carers.&#xD;
&#xD;
      No study has assessed the efficacy of such care with respect to the number of microbiological&#xD;
      specimens that remain in the humidifier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Preliminary results providing sufficient data&#xD;
  </why_stopped>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">August 20, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of microbial contamination of non invasive ventilators humidifier</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiological ecology in the study population</measure>
    <time_frame>7 days</time_frame>
    <description>The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology</measure>
    <time_frame>7 days</time_frame>
    <description>We will compare the microbiological ecology of patients in the COPD and in the Obesity hypoventilation group (percentage of each pathogen in each group)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to recommendations regarding the maintenance of the humidifier</measure>
    <time_frame>7 days</time_frame>
    <description>Compliance to recommendations will be assessed by a questionnaire containing 7 items regarding how the humidifier is maintained by the patient :&#xD;
Who is maintaining the ventilator (descriptive)&#xD;
At which frequency are you changing the water (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)&#xD;
What type of water are you using (descriptive)&#xD;
At which frequency are you cleaning the mask (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)&#xD;
At which frequency are you cleaning the humidifier (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)&#xD;
How are you cleaning the humidifier? Water (inadequate), soap (adequate), dishawashing liquid (inadequate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between compliance to maintenance recommendations and contamination rate</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Chronic Respiratory Failure</condition>
  <condition>COPD</condition>
  <condition>Obesity Hypoventilation Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients with COPD</arm_group_label>
    <description>Patients established on home non-invasive ventilation for COPD admitted for respiratory review will have a microbiological sampling of the ventilator humidifier</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with OHS</arm_group_label>
    <description>Patients established on home non-invasive ventilation for obesity hypoventilation syndrome admitted for respiratory review will have a microbiological sampling of the ventilator humidifier</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Microbiological sampling</intervention_name>
    <description>An microbiological sampling of the ventilator humidifier will be performed.</description>
    <arm_group_label>Patients with COPD</arm_group_label>
    <arm_group_label>Patients with OHS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients established on long term home non-invasive ventilation admitted for a scheduled&#xD;
        review.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient established on home non invasive ventilation for more than 6 months&#xD;
&#xD;
          -  With a compliance &gt;4hours/day&#xD;
&#xD;
          -  Who brought their ventilator for the assessment&#xD;
&#xD;
          -  Diagnosed with COPD or Obesity hypoventilation syndrome (OHS)&#xD;
&#xD;
          -  Who consent&#xD;
&#xD;
          -  With an age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  Ongoing exacerbation&#xD;
&#xD;
          -  Not able to consent&#xD;
&#xD;
          -  Pregnant or breastfeeding&#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>Maxime Patout, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Bois-Guillaume</city>
        <state>Normandy</state>
        <zip>76230</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 2, 2019</last_update_submitted>
  <last_update_submitted_qc>September 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2019</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>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypoventilation</mesh_term>
    <mesh_term>Obesity Hypoventilation Syndrome</mesh_term>
  </condition_browse>
  <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/NCT03809832
org study id: 2018/363/OB
nct id: NCT03809832
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Home non-invasive ventilators are daily used by patients with chronic respiratory failure.
      There are frequently used with warming and humidifying systems. These systems need to be
      cared for and frequently washed by the patient.

      The aim of this study is to evaluate if the humidifying system of home ventilators are
      colonized by microbiological germs.
The use of non-invasive ventilators is common for treating respiratory failure. Their care
      relies on the patients and their carers.

      No study has assessed the efficacy of such care with respect to the number of microbiological
      specimens that remain in the humidifier.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of microbial contamination of non invasive ventilators humidifier
time frame: 7 days
measure: Microbiological ecology in the study population
time frame: 7 days
description: The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)
measure: Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology
time frame: 7 days
description: We will compare the microbiological ecology of patients in the COPD and in the Obesity hypoventilation group (percentage of each pathogen in each group)
measure: Compliance to recommendations regarding the maintenance of the humidifier
time frame: 7 days
description: Compliance to recommendations will be assessed by a questionnaire containing 7 items regarding how the humidifier is maintained by the patient :
Who is maintaining the ventilator (descriptive)
At which frequency are you changing the water (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)
What type of water are you using (descriptive)
At which frequency are you cleaning the mask (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)
At which frequency are you cleaning the humidifier (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)
How are you cleaning the humidifier? Water (inadequate), soap (adequate), dishawashing liquid (inadequate)
measure: Correlation between compliance to maintenance recommendations and contamination rate
time frame: 7 days
measure: Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier
time frame: 12 months
arm group label: Patients with COPD
description: Patients established on home non-invasive ventilation for COPD admitted for respiratory review will have a microbiological sampling of the ventilator humidifier
arm group label: Patients with OHS
description: Patients established on home non-invasive ventilation for obesity hypoventilation syndrome admitted for respiratory review will have a microbiological sampling of the ventilator humidifier
intervention type: Diagnostic Test
intervention name: Microbiological sampling
description: An microbiological sampling of the ventilator humidifier will be performed.
arm group label: Patients with COPD
arm group label: Patients with OHS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maxime Patout, MD
role: Principal Investigator
affiliation: Rouen University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Hypoventilation
mesh term: Obesity Hypoventilation Syndrome
sharing ipd: No