xml: <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/NCT06032871</url>
    </required_header>
    <id_info>
      <org_study_id>IRB2212210081</org_study_id>
      <nct_id>NCT06032871</nct_id>
    </id_info>
    <brief_title>Comparisons of Two Airway Clearance Techniques</brief_title>
    <official_title>Comparison of Two Airway Clearance Techniques by Electrical Impedance Tomography- a Parallel Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hui-Ling Lin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chang Gung University</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this clinical trial is to compare the effectiveness of two airway clearance&#xD;
        techniques for patients with ventilator associated pneumonia. The main questions it aim to&#xD;
        answer are:&#xD;
  &#xD;
          -  effect of the therapies on volume changes&#xD;
  &#xD;
          -  outcome on sputum clearance Participants will receive airway clearance techniques of&#xD;
  &#xD;
          -  chest physiotherapy&#xD;
  &#xD;
          -  high frequency chest wall oscillation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sputum can be accumulated in the airways of intubated patients, resulting in recurrent&#xD;
        pneumonia. The airway clearance therapy is often utilized with chest physiotherapy or high&#xD;
        frequency chest wall oscillation which has become popular for its easy of use and less time&#xD;
        consuming to the healthcare workers. The main questions it aim to answer are on effectiveness&#xD;
        of the therapies on lung volume changes and sputum clearance by two airway clearance&#xD;
        techniques. With the oscillation of entire chest wall, the investigators hypothesize that the&#xD;
        high frequency chest wall oscillation is more effectively clear sputum in the distal airways.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 16, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The group will be coded and mask to the investigator and the outcome accessor.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>end-expiratory lung impedance</measure>
      <time_frame>Measurement before intervention, 30 after, 1 hour and 2 hours after intervention</time_frame>
      <description>Changes of global of impedance of lungs measure by the electrical impedance tomography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Weight of secretions</measure>
      <time_frame>Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention</time_frame>
      <description>Sputum amount is weighted.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Airway Clearance Impairment</condition>
    <arm_group>
      <arm_group_label>Chest physiotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive airway clearance by chest physiotherapy for 30 minutes twice a day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>high frequency chest wall oscillation</intervention_name>
      <description>Patients receive airway clearance by high frequency chest wall oscillation for 30 minutes twice a day.</description>
      <arm_group_label>Chest physiotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with chronic pulmonary disease&#xD;
  &#xD;
            -  Diagnosed with ventilator associated pneumonia&#xD;
  &#xD;
            -  Receive airway clearance therapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Head injury, spinal injury&#xD;
  &#xD;
            -  Instable hemodynamics&#xD;
  &#xD;
            -  Intercranial pressure &gt; 20 cmH2O&#xD;
  &#xD;
            -  Active hemoptysis&#xD;
  &#xD;
            -  Empyema&#xD;
  &#xD;
            -  Eye surgery&#xD;
  &#xD;
            -  Abdominal distension&#xD;
  &#xD;
            -  Chest tube insertion&#xD;
  &#xD;
            -  Active tuberculosis&#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>Hui-Ling Lin, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chang Gung University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hui-Ling Lin, PhD</last_name>
      <phone>+886-32118800</phone>
      <phone_ext>5228</phone_ext>
      <email>huiling@mail.cgu.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Linkou Chang Gung Memorial Hospital</name>
        <address>
          <city>Taoyuan</city>
          <zip>33305</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui-Ling Lin, MSc.</last_name>
        <phone>88632118800</phone>
        <phone_ext>5228</phone_ext>
        <email>huiling@mail.cgu.edu.tw</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chang Gung Memorial Hospital</name>
        <address>
          <city>Taoyuan</city>
          <zip>61363</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui-Ling Lin, MSc</last_name>
        <phone>88632118800</phone>
        <phone_ext>5228</phone_ext>
        <email>huiling@mail.cgu.edu.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <results_reference>
      <citation>Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.</citation>
      <PMID>31113857</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Chang Gung University</investigator_affiliation>
      <investigator_full_name>Hui-Ling Lin</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Airway clearance technique</keyword>
    <keyword>Ventilator associated pneumonia</keyword>
    <keyword>Electrical impedance tomography</keyword>
    <keyword>High frequency chest wall oscillation</keyword>
    <keyword>Chest physiotherapy</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>There is a plan to make all IPD that underlie results in a publication.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>The protocol is made available starting 6 months after publication.</ipd_time_frame>
      <ipd_access_criteria>The protocol is access upon request to the principle investigator.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032871
  org study id: IRB2212210081
  nct id: NCT06032871
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effectiveness of two airway clearance
        techniques for patients with ventilator associated pneumonia. The main questions it aim to
        answer are:
  
          -  effect of the therapies on volume changes
  
          -  outcome on sputum clearance Participants will receive airway clearance techniques of
  
          -  chest physiotherapy
  
          -  high frequency chest wall oscillation.
  Sputum can be accumulated in the airways of intubated patients, resulting in recurrent
        pneumonia. The airway clearance therapy is often utilized with chest physiotherapy or high
        frequency chest wall oscillation which has become popular for its easy of use and less time
        consuming to the healthcare workers. The main questions it aim to answer are on effectiveness
        of the therapies on lung volume changes and sputum clearance by two airway clearance
        techniques. With the oscillation of entire chest wall, the investigators hypothesize that the
        high frequency chest wall oscillation is more effectively clear sputum in the distal airways.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: The group will be coded and mask to the investigator and the outcome accessor.
  measure: end-expiratory lung impedance
  time frame: Measurement before intervention, 30 after, 1 hour and 2 hours after intervention
  description: Changes of global of impedance of lungs measure by the electrical impedance tomography
  measure: Weight of secretions
  time frame: Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention
  description: Sputum amount is weighted.
  arm group label: Chest physiotherapy
  arm group type: Experimental
  description: Patients receive airway clearance by chest physiotherapy for 30 minutes twice a day.
  intervention type: Procedure
  intervention name: high frequency chest wall oscillation
  description: Patients receive airway clearance by high frequency chest wall oscillation for 30 minutes twice a day.
  arm group label: Chest physiotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hui-Ling Lin, PhD
  role: Principal Investigator
  affiliation: Chang Gung University
  last name: Hui-Ling Lin, PhD
  phone: +886-32118800
  phone ext: 5228
  email: huiling@mail.cgu.edu.tw
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  citation: Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.
  PMID: 31113857
  responsible party type: Sponsor-Investigator
  investigator affiliation: Chang Gung University
  investigator full name: Hui-Ling Lin
  investigator title: Professor
  sharing ipd: Yes
  ipd description: There is a plan to make all IPD that underlie results in a publication.
  ipd info type: Study Protocol
  ipd time frame: The protocol is made available starting 6 months after publication.
  ipd access criteria: The protocol is access upon request to the principle investigator.