<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/NCT01692509</url>
  </required_header>
  <id_info>
    <org_study_id>NIV related practices</org_study_id>
    <nct_id>NCT01692509</nct_id>
  </id_info>
  <brief_title>Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort</brief_title>
  <official_title>Observation of Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort During NIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The practices and processes related to the administration of noninvasive ventilation (NIV) in&#xD;
      the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded&#xD;
      by an investigator at the bedside. The effect of the NIV treatment on various respiratory&#xD;
      parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be&#xD;
      recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Documentation of practices and processes related to NIV treatment</measure>
    <description>Documentation of practices and processes related to NIV administration in the adult intensive care unit(type of ventilator used, type of interface chosen, initial settings, organization of the care team and interactions between caregivers).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's Respiratory comfort</measure>
    <description>Patient's respiratory comfort during NIV will be assessed both by the patients themselves with a visual analogic scale and by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory parameters</measure>
    <description>Tidal volume, respiratory rate, inspiratory time, expiratory time and maximal and mean airway pressure will be measured from the continuous recording of airway pressure and flow obtained with a pneumotachograph.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Respiratory Failure Requiring Non Invasive Ventilation</condition>
  <arm_group>
    <arm_group_label>Patients requiring NIV</arm_group_label>
    <description>Patients requiring NIV because of acute respiratory failure</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients hospitalized in the CHUV intensive care unit who require non invasive&#xD;
        ventilation because of respiratory failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Respiratory failure&#xD;
&#xD;
          -  Therapeutic treatment by NIV required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Prophylactic NIV treatment&#xD;
&#xD;
          -  Continuous Positive Airway Pressure (CPAP)treatment&#xD;
&#xD;
          -  Denied consent&#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>Philippe Jolliet, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive care and burn unit, University Hospital of Lausanne</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>June 7, 2015</last_update_submitted>
  <last_update_submitted_qc>June 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Prof. Philippe Jolliet</investigator_full_name>
    <investigator_title>Main investigator</investigator_title>
  </responsible_party>
  <keyword>Non invasive ventilation</keyword>
  <keyword>Respiratory failure</keyword>
  <keyword>Respiratory comfort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01692509
org study id: NIV related practices
nct id: NCT01692509
lead sponsor: 
has dmc: No
The practices and processes related to the administration of noninvasive ventilation (NIV) in
      the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded
      by an investigator at the bedside. The effect of the NIV treatment on various respiratory
      parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be
      recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be
      evaluated.
observational model: Cohort
time perspective: Prospective
measure: Documentation of practices and processes related to NIV treatment
description: Documentation of practices and processes related to NIV administration in the adult intensive care unit(type of ventilator used, type of interface chosen, initial settings, organization of the care team and interactions between caregivers).
measure: Patient's Respiratory comfort
description: Patient's respiratory comfort during NIV will be assessed both by the patients themselves with a visual analogic scale and by the investigator.
measure: Ventilatory parameters
description: Tidal volume, respiratory rate, inspiratory time, expiratory time and maximal and mean airway pressure will be measured from the continuous recording of airway pressure and flow obtained with a pneumotachograph.
arm group label: Patients requiring NIV
description: Patients requiring NIV because of acute respiratory failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Jolliet, Professor
role: Principal Investigator
affiliation: University of Lausanne Hospitals
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Prof. Philippe Jolliet
investigator title: Main investigator
mesh term: Respiratory Insufficiency