<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/NCT03037801</url>
  </required_header>
  <id_info>
    <org_study_id>SOR-0074-16 CTIL</org_study_id>
    <nct_id>NCT03037801</nct_id>
  </id_info>
  <brief_title>Intrapulmonary Percussive Ventilation for Children With Bronchiolitis on Non-Invasive Ventilation Support</brief_title>
  <official_title>Prospective Randomized Controlled Study of the Use of Intrapulmonary Percussive Ventilation (IPV) for Children With Bronchiolitis Admitted to the Pediatric Intensive Care Unit (PICU) and Are on Non-Invasive Ventilation Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soroka University Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit&#xD;
      suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation.&#xD;
      The patient population will be divided into two groups, one group will receive conventional&#xD;
      treatment and the other group will receive conventional treatment and three times a day of&#xD;
      physiotherapy using Intrapulmonary Percussive Ventilation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of PICU Stay</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for Invasive Ventilation Support</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>S/F ratio</measure>
    <time_frame>Baseline, 15, 30 and 150 minutes after intervention</time_frame>
    <description>Pulse oximetry saturation/fraction of inspired oxygen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevention of lung atelectasis</measure>
    <time_frame>10 days</time_frame>
    <description>Per chest x-ray</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrapulmonary Percussive Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 minutes of IPV physiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)</intervention_name>
    <description>IPV physiotherapy 3 times a day</description>
    <arm_group_label>Intrapulmonary Percussive Ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bronchiolitis&#xD;
&#xD;
          -  PICU patients&#xD;
&#xD;
          -  Non Invasive Pressure Support Ventilation&#xD;
&#xD;
          -  Age &lt; 24 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 24 months&#xD;
&#xD;
          -  Invasive Ventilation&#xD;
&#xD;
          -  No parental consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuval Cavari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soroka UMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuval Cavari, MD</last_name>
    <phone>972-504562280</phone>
    <email>cavari@bgu.ac.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Soroka Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuval Cavari, MD</last_name>
      <phone>972504562280</phone>
      <email>cavari@bgu.ac.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>June 1, 2017</last_update_submitted>
  <last_update_submitted_qc>June 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037801
org study id: SOR-0074-16 CTIL
nct id: NCT03037801
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit
      suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation.
      The patient population will be divided into two groups, one group will receive conventional
      treatment and the other group will receive conventional treatment and three times a day of
      physiotherapy using Intrapulmonary Percussive Ventilation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Length of PICU Stay
time frame: 10 days
measure: Need for Invasive Ventilation Support
time frame: 10 days
measure: S/F ratio
time frame: Baseline, 15, 30 and 150 minutes after intervention
description: Pulse oximetry saturation/fraction of inspired oxygen
measure: Prevention of lung atelectasis
time frame: 10 days
description: Per chest x-ray
arm group label: Control
arm group type: No Intervention
arm group label: Intrapulmonary Percussive Ventilation
arm group type: Experimental
description: 15 minutes of IPV physiotherapy
intervention type: Device
intervention name: Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)
description: IPV physiotherapy 3 times a day
arm group label: Intrapulmonary Percussive Ventilation
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: No
last name: Yuval Cavari, MD
role: Principal Investigator
affiliation: Soroka UMC
last name: Yuval Cavari, MD
phone: 972-504562280
email: cavari@bgu.ac.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Bronchiolitis
sharing ipd: No