<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/NCT01677130</url>
  </required_header>
  <id_info>
    <org_study_id>FOV application</org_study_id>
    <nct_id>NCT01677130</nct_id>
  </id_info>
  <brief_title>Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ling Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea&#xD;
      and refractory hypoxemia caused by various reasons. Although in recent years a variety of&#xD;
      supportive care measures have significant progress, but the mortality rate of patients with&#xD;
      ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with&#xD;
      ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can&#xD;
      improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS&#xD;
      usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion&#xD;
      has heterogeneity. The protective mechanical ventilation strategies chosen by patients with&#xD;
      ARDS in clinical practice are gradually being accepted and applied. The High-frequency&#xD;
      oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal&#xD;
      volume. Compared with conventional mechanical ventilation, HFOV may be able to more&#xD;
      effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and&#xD;
      protective ventilation strategy in ARDS is consistent with an important position in the&#xD;
      treatment of ARDS, but not been widely adopted in clinical practice and is still only as a&#xD;
      salvage treatment. Therefore, this study intends to use HFOV treatment with conventional&#xD;
      mechanical ventilation by matching the cases in patients with ARDS. By comparing the&#xD;
      influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety,&#xD;
      and health economics effectiveness of HFOV are further investigated and adaption time and&#xD;
      parameter settings of HFOV are explored, which provide better treatment options for patients&#xD;
      with ARDS and improve their prognosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
  <enrollment type="Actual">24</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients of ARDS age&gt; 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt; 18 years;&#xD;
&#xD;
          -  lung protective ventilation (tidal volume 4-6ml/kg), airway plateau pressure is still&#xD;
             higher than 30cmH2O, or the failure of conventional mechanical ventilation&#xD;
             pneumothorax, bronchopleural fistula in patients with ARDS; of ARDS diagnosis in line&#xD;
             with the 2012 Berlin ARDS diagnostic criteria.&#xD;
&#xD;
          -  be able to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe pulmonary hemorrhage;&#xD;
&#xD;
          -  severe intracranial high pressure;&#xD;
&#xD;
          -  large airway stenosis and airway obstruction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Ling Liu</investigator_full_name>
    <investigator_title>Physician Zhongda Hospital</investigator_title>
  </responsible_party>
  <keyword>Clinical efficacy</keyword>
  <keyword>safety</keyword>
  <keyword>of HFOV treatment</keyword>
  <keyword>of patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT01677130
org study id: FOV application
nct id: NCT01677130
lead sponsor: 
has dmc: No
The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea
      and refractory hypoxemia caused by various reasons. Although in recent years a variety of
      supportive care measures have significant progress, but the mortality rate of patients with
      ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with
      ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can
      improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS
      usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion
      has heterogeneity. The protective mechanical ventilation strategies chosen by patients with
      ARDS in clinical practice are gradually being accepted and applied. The High-frequency
      oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal
      volume. Compared with conventional mechanical ventilation, HFOV may be able to more
      effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and
      protective ventilation strategy in ARDS is consistent with an important position in the
      treatment of ARDS, but not been widely adopted in clinical practice and is still only as a
      salvage treatment. Therefore, this study intends to use HFOV treatment with conventional
      mechanical ventilation by matching the cases in patients with ARDS. By comparing the
      influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety,
      and health economics effectiveness of HFOV are further investigated and adaption time and
      parameter settings of HFOV are explored, which provide better treatment options for patients
      with ARDS and improve their prognosis.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Southeast University, China
investigator full name: Ling Liu
investigator title: Physician Zhongda Hospital
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome