<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/NCT04505202</url>
  </required_header>
  <id_info>
    <org_study_id>2091</org_study_id>
    <nct_id>NCT04505202</nct_id>
  </id_info>
  <brief_title>Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications</brief_title>
  <official_title>Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karabuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karabuk University</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>
      Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory&#xD;
      tract infections associated with ventilator are common infections in intensive care unit and&#xD;
      cause significant morbidity, mortality and health expenditures in nosocomial infections.&#xD;
      Adequate and effective oral care by nurses in intensive care patients, possible&#xD;
      complications, intensive care unit stay in the intensive care unit and is very important in&#xD;
      terms of mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on&#xD;
      ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the&#xD;
      effect of preventing microorganism colonization, and (3) assess the mortality rate for each&#xD;
      patient and the cost-effectiveness in the health expenditures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">September 3, 2020</completion_date>
  <primary_completion_date type="Actual">March 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathogen colonization change</measure>
    <time_frame>change from baseline pathogen colonization at Day 3</time_frame>
    <description>We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral assessment guide score change</measure>
    <time_frame>at the time of admission into the study (day 0), at study day 2 and at day 3</time_frame>
    <description>The score ranges from 8 to 24 and higher scores indicating worse oral health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical pulmonary infection score change</measure>
    <time_frame>at the time of admission into the study (day 0), at study day 2 and at day 3</time_frame>
    <description>The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of tracheobronchitis change</measure>
    <time_frame>change from baseline the rate of tracheobronchitis at Day 3</time_frame>
    <description>Questionary (use the rate of tracheobronchitis categories)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cost effectiveness</measure>
    <time_frame>Day 30</time_frame>
    <description>We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Day 7 and Day 28</time_frame>
    <description>rate of mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Ventilator Associated Pneumonia</condition>
  <condition>Tracheobronchitis</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.12% chlorhexidine gluconate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>sodium bicarbonate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.12% chlorhexidine gluconate</intervention_name>
    <description>The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>sodium bicarbonate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Admission in critical care with in 24 hours&#xD;
&#xD;
          -  Having an endotracheal tube&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chlorhexidine allergy&#xD;
&#xD;
          -  Duration of mechanichal ventilation less than 48 h&#xD;
&#xD;
          -  Confirmed diagnosis of pneumonitis before admission in the ICU&#xD;
&#xD;
          -  Transfer from another ICU&#xD;
&#xD;
          -  Receiving chemotherapy or radiotherapy&#xD;
&#xD;
          -  Patients with immunodeficiency&#xD;
&#xD;
          -  Patients with tracheostomies&#xD;
&#xD;
          -  Required specific oral hygiene procedures&#xD;
&#xD;
          -  Facio-maxillary or dental trauma/surgery&#xD;
&#xD;
          -  Being pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karabük University Training and Research Hospital</name>
      <address>
        <city>Karabük</city>
        <state>Karabuk</state>
        <zip>78050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karabuk University</investigator_affiliation>
    <investigator_full_name>Duygu Kes</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_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/NCT04505202
org study id: 2091
nct id: NCT04505202
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory
      tract infections associated with ventilator are common infections in intensive care unit and
      cause significant morbidity, mortality and health expenditures in nosocomial infections.
      Adequate and effective oral care by nurses in intensive care patients, possible
      complications, intensive care unit stay in the intensive care unit and is very important in
      terms of mortality.
The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on
      ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the
      effect of preventing microorganism colonization, and (3) assess the mortality rate for each
      patient and the cost-effectiveness in the health expenditures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Pathogen colonization change
time frame: change from baseline pathogen colonization at Day 3
description: We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
measure: Oral assessment guide score change
time frame: at the time of admission into the study (day 0), at study day 2 and at day 3
description: The score ranges from 8 to 24 and higher scores indicating worse oral health
measure: Clinical pulmonary infection score change
time frame: at the time of admission into the study (day 0), at study day 2 and at day 3
description: The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )
measure: rate of tracheobronchitis change
time frame: change from baseline the rate of tracheobronchitis at Day 3
description: Questionary (use the rate of tracheobronchitis categories)
measure: cost effectiveness
time frame: Day 30
description: We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.
measure: Mortality
time frame: Day 7 and Day 28
description: rate of mortality
arm group label: Experimental group
arm group type: Experimental
description: 0.12% chlorhexidine gluconate
arm group label: Placebo group
arm group type: Placebo Comparator
description: sodium bicarbonate
intervention type: Drug
intervention name: 0.12% chlorhexidine gluconate
description: The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
arm group label: Experimental group
intervention type: Drug
intervention name: Placebo
description: The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care
arm group label: Placebo group
other name: sodium bicarbonate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karabuk University
investigator full name: Duygu Kes
investigator title: Principal Investigator
mesh term: Pneumonia, Ventilator-Associated
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate