<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/NCT02977676</url>
  </required_header>
  <id_info>
    <org_study_id>CONEP 1.449.854</org_study_id>
    <nct_id>NCT02977676</nct_id>
  </id_info>
  <brief_title>Ventilator-Associated Events: Prevalence, Outcome and Preventability</brief_title>
  <official_title>Ventilator-Associated Events: Prevalence, Outcome and Preventability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sao Domingos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Sao Domingos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the prevalence of ventilator-associated events (VAE).&#xD;
      To analyze the patients profile, morbidity and mortality compared to patients who did not&#xD;
      develope VAE. The preventability of VAE will be assessed by comparing the percentage of&#xD;
      adherence to the bundle of preventive measures among patients who developed and did not&#xD;
      develope VAE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective analysis of prospectively collected data, approved by the Research&#xD;
      Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived.&#xD;
&#xD;
      Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a&#xD;
      tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years&#xD;
      and submitted to mechanical ventilation for at least 4 days.&#xD;
&#xD;
      At admission and daily the following data were collected: head of bed elevation, daily&#xD;
      interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration&#xD;
      of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of&#xD;
      endotracheal tube cuff pressure.&#xD;
&#xD;
      Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated&#xD;
      to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable&#xD;
      followed definition criteria of the National Healthcare Safety Network / Center for Disease&#xD;
      Control and Prevention.&#xD;
&#xD;
      The percentage of adherence to the bundle of preventive measures of VAE prevention was&#xD;
      registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <primary_completion_date type="Actual">January 2016</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>Number of patients who developed ventilator-associated events</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>All cause Mortality</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of adherence to the package of VAE preventive measures</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Ventilator-Associated Lung Injury</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years&#xD;
        and submitted to mechanical ventilation for at least 4 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18&#xD;
             years and submitted to mechanical ventilation for at least 4 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged bellow 18 years and those that remained under mechanical ventilation&#xD;
             less than 4 days.&#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>JOSE R AZEVEDO, MA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Sao Domingos</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 25, 2016</last_update_submitted>
  <last_update_submitted_qc>November 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sao Domingos</investigator_affiliation>
    <investigator_full_name>José Raimundo Araujo de Azevedo</investigator_full_name>
    <investigator_title>Coordinator of ICU</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</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/NCT02977676
org study id: CONEP 1.449.854
nct id: NCT02977676
lead sponsor: 
has dmc: Yes
The aim of this study is to determine the prevalence of ventilator-associated events (VAE).
      To analyze the patients profile, morbidity and mortality compared to patients who did not
      develope VAE. The preventability of VAE will be assessed by comparing the percentage of
      adherence to the bundle of preventive measures among patients who developed and did not
      develope VAE.
This is a retrospective analysis of prospectively collected data, approved by the Research
      Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived.

      Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a
      tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years
      and submitted to mechanical ventilation for at least 4 days.

      At admission and daily the following data were collected: head of bed elevation, daily
      interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration
      of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of
      endotracheal tube cuff pressure.

      Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated
      to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable
      followed definition criteria of the National Healthcare Safety Network / Center for Disease
      Control and Prevention.

      The percentage of adherence to the bundle of preventive measures of VAE prevention was
      registered.
observational model: Cohort
time perspective: Retrospective
measure: Number of patients who developed ventilator-associated events
time frame: 1 year
measure: All cause Mortality
time frame: 1 year
measure: Duration of mechanical ventilation
time frame: 1 year
measure: Percentage of adherence to the package of VAE preventive measures
time frame: 1 year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JOSE R AZEVEDO, MA, PhD
role: Principal Investigator
affiliation: Hospital Sao Domingos
responsible party type: Principal Investigator
investigator affiliation: Hospital Sao Domingos
investigator full name: José Raimundo Araujo de Azevedo
investigator title: Coordinator of ICU
mesh term: Lung Injury