<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/NCT02214368</url>
  </required_header>
  <id_info>
    <org_study_id>YB20130097</org_study_id>
    <nct_id>NCT02214368</nct_id>
  </id_info>
  <brief_title>Noninvasive Ventilation Bundle in Postoperative Respiratory Failure</brief_title>
  <official_title>The Efficacy and Safety of Noninvasive Ventilation Bundle in Postoperative Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV)&#xD;
      bundle strategy compared with a conventional treatment in postoperative patients with ARF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, prospective, open-label study. Postoperative patients with ARF included&#xD;
      in the study were randomly assigned to intervention group or conventional treatment group. In&#xD;
      the intervention group, NIV was early used for treatment of postoperative respiratory&#xD;
      failure, if patients were inability to spontaneously clear airways from excessive secretions&#xD;
      during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions , if patients&#xD;
      showed intolerance or inadequate patient cooperation during the NIV session, they were&#xD;
      sedated (Ramsay scale 2-3) by a continuous perfusion of propofol during the NIV session.&#xD;
&#xD;
      Patients assigned to the control group received supplemental oxygen, Respiratory therapists&#xD;
      delivered this intervention using conventional masks or venturi oxygen, and adjusted FiO2 to&#xD;
      achieve arterial O2 saturation of more than 92%. The application of noninvasive ventilation&#xD;
      was considered, if patients failed the supplemental oxygen and met at least two of the&#xD;
      following criteria:(1) severe respiratory distress with dyspnoea, respiratory&#xD;
      rate&gt;30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased&#xD;
      respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing,&#xD;
      or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2&#xD;
      of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less&#xD;
      than 60 mm Hg at an FiO2&gt; 0.5 or breathing at least 10 l/min oxygen.&#xD;
&#xD;
      All the patients were continuous monitored of vital signs.whereas arterial blood gases were&#xD;
      analyzed before NIV and 1h after NIV, before and after FBO, and once a day and in the case of&#xD;
      any change either in the ventilatory settings or in the FIO2; duration of noninvasive&#xD;
      ventilation, the rate and cause of endotracheal intubation, ICU and hospital mortality and&#xD;
      length of stay in the ICU and in hospital, study procedure related complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the need of endotracheal intubation</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>NIV bundle group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>early use of NIV, and combination fiberoptic bronchoscopy and sedation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional treatment group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>standard supplemental oxygen, and conventional application of noninvasive ventilation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early application of NIV</intervention_name>
    <description>Device:BiPAP Vision.&#xD;
NIV bundle group : Early application of NIV(BiPAP Vision) in 1 h after randomization.</description>
    <arm_group_label>NIV bundle group</arm_group_label>
    <other_name>Early application of BiPAP Vision (Respironics)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fiberoptic bronchoscopy</intervention_name>
    <description>Device:fiberoptic bronchoscopy. NIV bundle group :When patients were inability to spontaneously clear airways from excessive secretions during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions.</description>
    <arm_group_label>NIV bundle group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Drug:propofol.continuous perfusion of propofol (0.50-2.00 mg/kg/h).&#xD;
NIV bundle group :When patients showed intolerance or inadequate patient cooperation during the NIV session, they were sedated (Ramsay scale 2-3) by a continuous perfusion of propofol (0.50-2.00 mg/kg/h).&#xD;
In the conventional treatment group: No intervention.</description>
    <arm_group_label>NIV bundle group</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional application of NIV</intervention_name>
    <description>Conventional treatment group:NIV(BiPAP Vision) was used, when patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate&gt;30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less than 60 mm Hg at an FiO2&gt; 0.5 or breathing at least 10 L/min oxygen.</description>
    <arm_group_label>Conventional treatment group</arm_group_label>
    <other_name>Conventional application of BiPAP Vision (Respironics)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postoperative patients with acute respiratory failure (ARF) were included in the&#xD;
             study,who had to meet one of the following criteria&#xD;
&#xD;
          -  Respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more)&#xD;
&#xD;
          -  Partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio&#xD;
             less than 250&#xD;
&#xD;
          -  Dyspnoea with respiratory rate &gt; 25 breaths/min or use of accessory respiratory&#xD;
             muscles or paradoxical abdominal breathing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac or respiratory arrest; loss of consciousness&#xD;
&#xD;
          -  Facial trauma or surgery or deformity sufficient to preclude mask fitting&#xD;
&#xD;
          -  Active upper gastrointestinal bleeding&#xD;
&#xD;
          -  Haemodynamic instability or unstable cardiac arrhythmia&#xD;
&#xD;
          -  Multiple organ failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Y F Zhou, MM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of critical care medicine of West China Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Critical care medicine of West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 15, 2015</last_update_submitted>
  <last_update_submitted_qc>August 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Zhou Yongfang</investigator_full_name>
    <investigator_title>Master of medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</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/NCT02214368
org study id: YB20130097
nct id: NCT02214368
lead sponsor: 
has dmc: Yes
The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV)
      bundle strategy compared with a conventional treatment in postoperative patients with ARF.
This is a randomized, prospective, open-label study. Postoperative patients with ARF included
      in the study were randomly assigned to intervention group or conventional treatment group. In
      the intervention group, NIV was early used for treatment of postoperative respiratory
      failure, if patients were inability to spontaneously clear airways from excessive secretions
      during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions , if patients
      showed intolerance or inadequate patient cooperation during the NIV session, they were
      sedated (Ramsay scale 2-3) by a continuous perfusion of propofol during the NIV session.

      Patients assigned to the control group received supplemental oxygen, Respiratory therapists
      delivered this intervention using conventional masks or venturi oxygen, and adjusted FiO2 to
      achieve arterial O2 saturation of more than 92%. The application of noninvasive ventilation
      was considered, if patients failed the supplemental oxygen and met at least two of the
      following criteria:(1) severe respiratory distress with dyspnoea, respiratory
      rate>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased
      respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing,
      or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2
      of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less
      than 60 mm Hg at an FiO2> 0.5 or breathing at least 10 l/min oxygen.

      All the patients were continuous monitored of vital signs.whereas arterial blood gases were
      analyzed before NIV and 1h after NIV, before and after FBO, and once a day and in the case of
      any change either in the ventilatory settings or in the FIO2; duration of noninvasive
      ventilation, the rate and cause of endotracheal intubation, ICU and hospital mortality and
      length of stay in the ICU and in hospital, study procedure related complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the need of endotracheal intubation
time frame: 7 days
arm group label: NIV bundle group
arm group type: Experimental
description: early use of NIV, and combination fiberoptic bronchoscopy and sedation
arm group label: Conventional treatment group
arm group type: Other
description: standard supplemental oxygen, and conventional application of noninvasive ventilation.
intervention type: Other
intervention name: Early application of NIV
description: Device:BiPAP Vision.
NIV bundle group : Early application of NIV(BiPAP Vision) in 1 h after randomization.
arm group label: NIV bundle group
other name: Early application of BiPAP Vision (Respironics)
intervention type: Device
intervention name: Fiberoptic bronchoscopy
description: Device:fiberoptic bronchoscopy. NIV bundle group :When patients were inability to spontaneously clear airways from excessive secretions during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions.
arm group label: NIV bundle group
intervention type: Drug
intervention name: Propofol
description: Drug:propofol.continuous perfusion of propofol (0.50-2.00 mg/kg/h).
NIV bundle group :When patients showed intolerance or inadequate patient cooperation during the NIV session, they were sedated (Ramsay scale 2-3) by a continuous perfusion of propofol (0.50-2.00 mg/kg/h).
In the conventional treatment group: No intervention.
arm group label: NIV bundle group
other name: Diprivan
intervention type: Other
intervention name: Conventional application of NIV
description: Conventional treatment group:NIV(BiPAP Vision) was used, when patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less than 60 mm Hg at an FiO2> 0.5 or breathing at least 10 L/min oxygen.
arm group label: Conventional treatment group
other name: Conventional application of BiPAP Vision (Respironics)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Y F Zhou, MM
role: Principal Investigator
affiliation: Department of critical care medicine of West China Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Zhou Yongfang
investigator title: Master of medicine
mesh term: Respiratory Insufficiency
mesh term: Propofol