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/NCT06000618</url>
    </required_header>
    <id_info>
      <org_study_id>STPH-ICU-006</org_study_id>
      <nct_id>NCT06000618</nct_id>
    </id_info>
    <brief_title>Effects of Intrapulmonary Percussive Ventilator on Respiratory Function</brief_title>
    <official_title>Effects of Intrapulmonary Percussive Ventilator on Respiratory Function: an Experiment in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai 10th People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai 10th People's Hospital</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 prove the benefit of intrapulmonary percussive&#xD;
        ventilator in healthy volunteers. The main questions are:&#xD;
  &#xD;
          -  How can intrapulmonary percussive improve lung function？&#xD;
  &#xD;
          -  What is the subjective feeling through intrapulmonary percussive?&#xD;
  &#xD;
        Participants will be undergoing treatment of intrapulmonary percussive. Then they will be&#xD;
        assessed for lung function and EIT before and after intrapulmonary percussive.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pulmonary function test</measure>
      <time_frame>through study completion, an average one hour</time_frame>
      <description>This test can assess the volunteer's lung ventilation and diffusion function.For example the max vital capacity (VCMAX),Forced vital capacity(FVC),Forced expiratory volume in one second(FEV1),functional residual capacity(FRC-SB),diffusion capacity of lung for carbon monoxide(DLCO) and so on.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Electrical Impedance Tomography of Pulmonary(EIT)</measure>
      <time_frame>through study completion, an average one hour</time_frame>
      <description>EIT is a relatively advanced non-invasive monitoring technique for the lung function. This technology uses a strap attached to the chest to monitor electrical at 16 locations. The Ventilation in each area resistance of the lung is quantified according to the electrical resistance</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The safety and comfort</measure>
      <time_frame>The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.</time_frame>
      <description>Whether the technique has adverse reactions. How do the volunteers feel? We used a scale of 1 to 4 to show how the volunteers felt. 1 is the worst feeling. The volunteers were no longer willing to undergo the treatment. 4 means the volunteers felt better and breathed easier after the treatment. Be willing to undergo endoairway shock therapy again.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Airway Clearance Impairment</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group will undergo intrapulmonary percussive therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Intrapulmonary Percussive ventilator</intervention_name>
      <description>The volunteers will undergo three minutes low frequency and high frequency intrapulmonary percussive treatments.</description>
      <arm_group_label>experimental group</arm_group_label>
      <other_name>MateNeb</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  No respiratory system, heart disease&#xD;
  &#xD;
            -  Well cooperate with the MateNeb&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the&#xD;
               last month&#xD;
  &#xD;
            -  Couldn't finish three times pulmonary function test&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sheng Wang, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai 10th People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xin Jing, Dr</last_name>
      <phone>+86-18917682679</phone>
      <email>lingzi_jx@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xing Qi Wang, Dr</last_name>
      <phone>+86-18917683119</phone>
      <email>wangqixing1221@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shanghai Tenth People's Hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xin Jing, Dr</last_name>
        <phone>+8618917682679</phone>
        <email>lingzi_jx@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Xing Qi Wang, Dr</last_name>
        <phone>+8618917683119</phone>
        <email>wangqixing1221@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Sheng Wang, PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Hassan A, Milross M, Lai W, Shetty D, Alison J, Huang S. Feasibility and safety of intrapulmonary percussive ventilation in spontaneously breathing, non-ventilated patients in critical care: A retrospective pilot study. J Intensive Care Soc. 2021 May;22(2):111-119. doi: 10.1177/1751143720909704. Epub 2020 Mar 12.</citation>
      <PMID>34025750</PMID>
    </reference>
    <results_reference>
      <citation>Nyland BA, Spilman SK, Halub ME, Lamb KD, Jackson JA, Oetting TW, Sahr SM. A Preventative Respiratory Protocol to Identify Trauma Subjects at Risk for Respiratory Compromise on a General In-Patient Ward. Respir Care. 2016 Dec;61(12):1580-1587. doi: 10.4187/respcare.04729. Epub 2016 Nov 8.</citation>
      <PMID>27827332</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
      <investigator_full_name>Sheng Wang MD PhD</investigator_full_name>
      <investigator_title>MD PhD</investigator_title>
    </responsible_party>
    <keyword>Intrapulmonary percussive</keyword>
    <keyword>Healthy volunteer</keyword>
    <keyword>pulmonary function</keyword>
    <keyword>Electrical Impedance Tomography</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06000618
  org study id: STPH-ICU-006
  nct id: NCT06000618
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to prove the benefit of intrapulmonary percussive
        ventilator in healthy volunteers. The main questions are:
  
          -  How can intrapulmonary percussive improve lung function？
  
          -  What is the subjective feeling through intrapulmonary percussive?
  
        Participants will be undergoing treatment of intrapulmonary percussive. Then they will be
        assessed for lung function and EIT before and after intrapulmonary percussive.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Pulmonary function test
  time frame: through study completion, an average one hour
  description: This test can assess the volunteer's lung ventilation and diffusion function.For example the max vital capacity (VCMAX),Forced vital capacity(FVC),Forced expiratory volume in one second(FEV1),functional residual capacity(FRC-SB),diffusion capacity of lung for carbon monoxide(DLCO) and so on.
  measure: Electrical Impedance Tomography of Pulmonary(EIT)
  time frame: through study completion, an average one hour
  description: EIT is a relatively advanced non-invasive monitoring technique for the lung function. This technology uses a strap attached to the chest to monitor electrical at 16 locations. The Ventilation in each area resistance of the lung is quantified according to the electrical resistance
  measure: The safety and comfort
  time frame: The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.
  description: Whether the technique has adverse reactions. How do the volunteers feel? We used a scale of 1 to 4 to show how the volunteers felt. 1 is the worst feeling. The volunteers were no longer willing to undergo the treatment. 4 means the volunteers felt better and breathed easier after the treatment. Be willing to undergo endoairway shock therapy again.
  arm group label: experimental group
  arm group type: Experimental
  description: The experimental group will undergo intrapulmonary percussive therapy
  intervention type: Device
  intervention name: Intrapulmonary Percussive ventilator
  description: The volunteers will undergo three minutes low frequency and high frequency intrapulmonary percussive treatments.
  arm group label: experimental group
  other name: MateNeb
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sheng Wang, PHD
  role: Principal Investigator
  affiliation: Shanghai 10th People's Hospital
  last name: Xin Jing, Dr
  phone: +86-18917682679
  email: lingzi_jx@163.com
  last name: Xing Qi Wang, Dr
  phone: +86-18917683119
  email: wangqixing1221@163.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Hassan A, Milross M, Lai W, Shetty D, Alison J, Huang S. Feasibility and safety of intrapulmonary percussive ventilation in spontaneously breathing, non-ventilated patients in critical care: A retrospective pilot study. J Intensive Care Soc. 2021 May;22(2):111-119. doi: 10.1177/1751143720909704. Epub 2020 Mar 12.
  PMID: 34025750
  citation: Nyland BA, Spilman SK, Halub ME, Lamb KD, Jackson JA, Oetting TW, Sahr SM. A Preventative Respiratory Protocol to Identify Trauma Subjects at Risk for Respiratory Compromise on a General In-Patient Ward. Respir Care. 2016 Dec;61(12):1580-1587. doi: 10.4187/respcare.04729. Epub 2016 Nov 8.
  PMID: 27827332
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai 10th People's Hospital
  investigator full name: Sheng Wang MD PhD
  investigator title: MD PhD
  sharing ipd: No