<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/NCT04435353</url>
  </required_header>
  <id_info>
    <org_study_id>AstanaMU</org_study_id>
    <nct_id>NCT04435353</nct_id>
  </id_info>
  <brief_title>Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19</brief_title>
  <official_title>Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astana Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astana Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive&#xD;
      effect on oxygen status and a decrease in the duration of respiratory failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to recruit the required number of patients for statistical identification of&#xD;
      the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance&#xD;
      criteria will be presented by the duration of the course of respiratory failure and the&#xD;
      duration of mechanical ventilation in the main and control groups. Optional performance&#xD;
      criteria will be represented by oximetry values and standardization of laboratory parameters&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 22, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>
    <intervention_model_description>Prospective\retrospective study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Research involves single blinding (researcher statistician)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery respiratory fail</measure>
    <time_frame>5-7 days</time_frame>
    <description>Regression of respiratory failure under the influence of vibroacoustic therapy</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Respiratory Distress Syndrome</condition>
  <condition>Hypoxemia</condition>
  <arm_group>
    <arm_group_label>Time-day of respiratory fail</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Objective data</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxygen status</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Facultative data</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxugen support</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FiO2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adverse outcomes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Complication</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VibroLUNG</intervention_name>
    <description>Lungs intensive therapy</description>
    <arm_group_label>Adverse outcomes</arm_group_label>
    <arm_group_label>Oxugen support</arm_group_label>
    <arm_group_label>Oxygen status</arm_group_label>
    <arm_group_label>Time-day of respiratory fail</arm_group_label>
    <other_name>Vibroacustic device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. adults&#xD;
&#xD;
          2. P/F less 300 torr&#xD;
&#xD;
          3. ARDS by Berlin convention&#xD;
&#xD;
          4. COVID 19 bilateral pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. children&#xD;
&#xD;
          2. acute brain stroke&#xD;
&#xD;
          3. acute coronary syndrome&#xD;
&#xD;
          4. pulmonary embolism&#xD;
&#xD;
          5. implanted pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Irina Mukatova, PhD</last_name>
    <phone>8701 535 96 79</phone>
    <email>mukatovair@mail.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mukatova Irina</name>
      <address>
        <city>Astana</city>
        <state>Nur-Sultan</state>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irina Mukatova, MD</last_name>
      <phone>8701 535 96 79</phone>
      <email>mukatovair@mail.ru</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Center of pulmonology Astana</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivan Vahrushev, Dr</last_name>
      <phone>8701 196 92 68</phone>
    </contact>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Astana Medical University</investigator_affiliation>
    <investigator_full_name>Mukatova Irina</investigator_full_name>
    <investigator_title>PhD. Professor of medicine. Head of deparment pulmonology</investigator_title>
  </responsible_party>
  <keyword>Vibroacustic therapy</keyword>
  <keyword>COVID19</keyword>
  <keyword>Pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypoxia</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/NCT04435353
org study id: AstanaMU
nct id: NCT04435353
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive
      effect on oxygen status and a decrease in the duration of respiratory failure
This study aims to recruit the required number of patients for statistical identification of
      the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance
      criteria will be presented by the duration of the course of respiratory failure and the
      duration of mechanical ventilation in the main and control groups. Optional performance
      criteria will be represented by oximetry values and standardization of laboratory parameters
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective\retrospective study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Research involves single blinding (researcher statistician)
measure: Recovery respiratory fail
time frame: 5-7 days
description: Regression of respiratory failure under the influence of vibroacoustic therapy
arm group label: Time-day of respiratory fail
arm group type: Active Comparator
description: Objective data
arm group label: Oxygen status
arm group type: Active Comparator
description: Facultative data
arm group label: Oxugen support
arm group type: Active Comparator
description: FiO2
arm group label: Adverse outcomes
arm group type: Active Comparator
description: Complication
intervention type: Device
intervention name: VibroLUNG
description: Lungs intensive therapy
arm group label: Adverse outcomes
arm group label: Oxugen support
arm group label: Oxygen status
arm group label: Time-day of respiratory fail
other name: Vibroacustic device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Irina Mukatova, PhD
phone: 8701 535 96 79
email: mukatovair@mail.ru
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Kazakhstan
responsible party type: Principal Investigator
investigator affiliation: Astana Medical University
investigator full name: Mukatova Irina
investigator title: PhD. Professor of medicine. Head of deparment pulmonology
mesh term: COVID-19
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Hypoxia