<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/NCT02223988</url>
  </required_header>
  <id_info>
    <org_study_id>CS/202</org_study_id>
    <nct_id>NCT02223988</nct_id>
  </id_info>
  <brief_title>Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage</brief_title>
  <acronym>VICTOR</acronym>
  <official_title>Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</source>
  <brief_summary>
    <textblock>
      Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks&#xD;
      of morbidity and mortality for patients who require mechanical ventilation.&#xD;
&#xD;
      VAP is associated with the contamination and colonization of bacteria in the lower airway.&#xD;
      These bacteria may be present in the lower airway by the aspiration of oropharyngeal&#xD;
      secretions. Therefore limiting the amount of secretions that pass the glottis and enter the&#xD;
      airway is paramount.&#xD;
&#xD;
      Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to&#xD;
      manage breathing. These tubes may have a distal cuff which sits within the trachea. When the&#xD;
      cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube&#xD;
      thereby limiting the amount of secretions entering the lower airway. These secretions may&#xD;
      leak around the cuff and cause tracheobronchial colonization. It has been shown that removal&#xD;
      of secretions that pool above the cuff via dorsal lumen suction leads to a decreased&#xD;
      incidence of VAP.&#xD;
&#xD;
      The purpose of this study is to measure the effect of suction above the cuff tracheostomy&#xD;
      tubes related to VAP incidence&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of VAP</measure>
    <time_frame>at 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>at 28 days</time_frame>
    <description>Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator free days after tracheostomy</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>subglottic secretion drainage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subglottic secretion removal</intervention_name>
    <arm_group_label>subglottic secretion drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients on mechanical ventilation for respiratory failure for at least 72 hours.&#xD;
&#xD;
          -  A score of 35 to 65 on the Simplified Acute Physiology Score II (SAPS II).&#xD;
&#xD;
          -  Does not have a pulmonary infection estimated by a Clinical Pulmonary Infection Score&#xD;
             (CPIS).&#xD;
&#xD;
          -  Age &gt;= 18 years.&#xD;
&#xD;
          -  have no exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of esophageal, tracheal or pulmonary cancer or an existing malignancy within&#xD;
             the trachea at the tracheostomy site.&#xD;
&#xD;
          -  Previous surgery at the tracheostomy site (e.g. thyroidectomy).&#xD;
&#xD;
          -  Bleeding diathesis (e.g. due to anticoagulation therapy).&#xD;
&#xD;
          -  Emergency surgical airway management.&#xD;
&#xD;
          -  Morbid obesity and/or neck edema (skin to trachea distance may render tracheostomy&#xD;
             tube too short).&#xD;
&#xD;
          -  Pre-existing infection at the tracheostomy site.&#xD;
&#xD;
          -  Uncertainty in identifying the anatomical landmarks.&#xD;
&#xD;
          -  Patients with a do not resuscitate order.&#xD;
&#xD;
          -  Immunosuppressed and/or immunodepressed patients (Immunodepression being defined by&#xD;
             the following conditions: 1-Leukocytes &lt; 1000/µl, 2-Neutrophils &lt; 500/µl. 3-AIDS&#xD;
             Long-term steroid treatment (daily dose &gt; 0.5 mg/kg) for more than 30 days)&#xD;
&#xD;
          -  Patients already enrolled in other trials&#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>Pierpaolo Terragni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Turin - Department of Anesthesia and Intensive Care Medicine</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>May 5, 2017</last_update_submitted>
  <last_update_submitted_qc>May 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Marco Ranieri</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Patients</keyword>
  <keyword>mechanical</keyword>
  <keyword>ventilation</keyword>
  <keyword>tracheostomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
    <mesh_term>Respiratory Insufficiency</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/NCT02223988
org study id: CS/202
nct id: NCT02223988
lead sponsor: 
Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks
      of morbidity and mortality for patients who require mechanical ventilation.

      VAP is associated with the contamination and colonization of bacteria in the lower airway.
      These bacteria may be present in the lower airway by the aspiration of oropharyngeal
      secretions. Therefore limiting the amount of secretions that pass the glottis and enter the
      airway is paramount.

      Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to
      manage breathing. These tubes may have a distal cuff which sits within the trachea. When the
      cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube
      thereby limiting the amount of secretions entering the lower airway. These secretions may
      leak around the cuff and cause tracheobronchial colonization. It has been shown that removal
      of secretions that pool above the cuff via dorsal lumen suction leads to a decreased
      incidence of VAP.

      The purpose of this study is to measure the effect of suction above the cuff tracheostomy
      tubes related to VAP incidence
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of VAP
time frame: at 28 days
measure: Mortality rate
time frame: at 28 days
description: Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)
measure: Duration of mechanical ventilation
time frame: 30 days
measure: ICU length of stay
time frame: 30 days
measure: Ventilator free days after tracheostomy
time frame: 28 days
arm group label: subglottic secretion drainage
arm group type: Experimental
intervention type: Procedure
intervention name: subglottic secretion removal
arm group label: subglottic secretion drainage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierpaolo Terragni, MD
role: Principal Investigator
affiliation: Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Marco Ranieri
investigator title: MD
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
mesh term: Respiratory Insufficiency