<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/NCT02987036</url>
  </required_header>
  <id_info>
    <org_study_id>nebulizer</org_study_id>
    <nct_id>NCT02987036</nct_id>
  </id_info>
  <brief_title>Delivery of Beta Agonists is Technique Sensitive (DOBATS)Mechanics</brief_title>
  <official_title>Administration of Beta-agonistic Drug Using Two Different Nebulizer Technologies: Effects on Lung Mechanics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</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 purpose of this study is to find out weather differences in administration nebulizer&#xD;
      technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables&#xD;
      (Compliance, resistance and PEEPi) during controlled mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The delivery of aerosols has a two fold appeal as it is distributed direct to the tracheo-&#xD;
      bronchial tree and alveolar epithelium. The drug is then rapidly absorbed by the circulation&#xD;
      avoiding the first pass entero-hepatic metabolic effect.&#xD;
&#xD;
      The systemic effects may be regarded as a side effect in the case were the primary&#xD;
      therapeutic target is aimed at the bronchial tree as is the case with broncho-active drugs,&#xD;
      such as β2-stimulants.&#xD;
&#xD;
      The ability of particles to remain suspended in a gas can be predicted from their size, shape&#xD;
      and density, coupled with the density and viscosity of the gas. The properties of an aerosol&#xD;
      is commonly expressed as the Mass Median Aerosol Diameter MMAD, a measure of the average&#xD;
      particle size and the geometric standard deviation. It is calculated from the cumulative&#xD;
      particle size curve1. The MMAD will give a reliable estimate of the likely deposition of the&#xD;
      drug along the tracheo-bronchial tree. A particle size &gt;5 will likely deposit in the upper&#xD;
      airways, while particles with an MMAD of 2-5 is likely to deposit in the tracheo-bronchial&#xD;
      tree2.&#xD;
&#xD;
      Jet nebulizers are the most commonly used devices for aerosol therapy. However, the MMAD&#xD;
      generated by this device is unpredictable, often leading to the drug being deposited in the&#xD;
      ventilator circuit or endotracheal tube3.&#xD;
&#xD;
      An alternative is the vibrating mesh nebulizer, which is based on a high frequency vibrating&#xD;
      piezoelectric crystal. The crystal will vibrate a micron mesh at a very high frequency. A&#xD;
      micro pump will deliver a small volume of liquid from a reservoir into the vibrating mesh&#xD;
      resulting in a very precise aerosol generation3.&#xD;
&#xD;
      Nebulizer therapy is often prescribed without proven effects or proper evaluation of result.&#xD;
      Indeed, two large multicenter trial in acute lung injury patients were discontinued at&#xD;
      interim analyses due to lack of effect4,5. This lack of effect may be due to the nebulizer&#xD;
      technology (Jet nebulizer), the indication (ARDS), or primary outcome.&#xD;
&#xD;
      The investigators would like to compare the difference in therapeutic effect between these&#xD;
      two devices as this has not been published previously. It is well known that the physical&#xD;
      properties of the generated aerosol may differ widely, depending on device and technology&#xD;
      used. Hence, even if the same amount of drug is administered, distribution and uptake will&#xD;
      not be the same. It can further be expected that the therapeutic response will be different.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of intrinsi PPPE</measure>
    <time_frame>0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of respioratory resistance</measure>
    <time_frame>0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of respiratory system Compliance</measure>
    <time_frame>0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Aerogen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Aerogen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jet Nebulizer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet Nebulizer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aerogen</intervention_name>
    <description>Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by mesh nebulizer</description>
    <arm_group_label>Aerogen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Jet nebulizer</intervention_name>
    <description>Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet nebulizer</description>
    <arm_group_label>Jet Nebulizer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients on mechanical ventilation for more than 48 hours&#xD;
&#xD;
          -  PEEPi ≥3 cm H2O and expected to remain on controlled mechanical ventilation for at&#xD;
             least 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe chronic lung disease with chronic hypercapnia (PCO2&gt;45 mm Hg), Chronic&#xD;
             hypoxemia (PO2&lt; 55mm Hg with FiO2=0,21), hospitalization within last 6 months for&#xD;
             respiratory failure (PCO2&gt;50; PO2&lt;55mm Hg), Secondary polycythemia, severe pulmonary&#xD;
             hypertension (mPAP &gt;40 mm Hg.&#xD;
&#xD;
          -  Unable to obtain consent&#xD;
&#xD;
          -  Acute myocardial infarction&#xD;
&#xD;
          -  Severe congestive heart failure&#xD;
&#xD;
          -  Heart rate greater than maximal predicted heart rate MHR85 (MHR 85=0.85 x (220-age).&#xD;
&#xD;
          -  Burns over more than 40% of body surface area&#xD;
&#xD;
          -  Cancer or other irreversible disease or condition for which 6-month mortality is&#xD;
             estimated to be greater than 50%&#xD;
&#xD;
          -  Allogenic bone marrow transplantation within 5 years prior to the study&#xD;
&#xD;
          -  Diffuse alveolar hemorrhage from vaculitis&#xD;
&#xD;
          -  Morbid obesity&#xD;
&#xD;
          -  Moribund, not expected to survive 24 hours&#xD;
&#xD;
          -  Daily use of beta agonists prior to hospitalization&#xD;
&#xD;
          -  Participation in other study&#xD;
&#xD;
          -  Chronic liver disease&#xD;
&#xD;
          -  Neuromuscular disease that impairs ability to breath without assistance (e.g. Cervical&#xD;
             spine cord injury at level C5 and higher, Amyotrophic lateral sclerosis,&#xD;
             Guillain-Barre syndrome or myasthenia gravis)&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ling Ling, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Zhongda Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongda Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</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 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Ling Liu</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>nebulizer technologies, lung mechanics, beta-agonistic drug</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT02987036
org study id: nebulizer
nct id: NCT02987036
lead sponsor: 
has dmc: No
The purpose of this study is to find out weather differences in administration nebulizer
      technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables
      (Compliance, resistance and PEEPi) during controlled mechanical ventilation.
The delivery of aerosols has a two fold appeal as it is distributed direct to the tracheo-
      bronchial tree and alveolar epithelium. The drug is then rapidly absorbed by the circulation
      avoiding the first pass entero-hepatic metabolic effect.

      The systemic effects may be regarded as a side effect in the case were the primary
      therapeutic target is aimed at the bronchial tree as is the case with broncho-active drugs,
      such as β2-stimulants.

      The ability of particles to remain suspended in a gas can be predicted from their size, shape
      and density, coupled with the density and viscosity of the gas. The properties of an aerosol
      is commonly expressed as the Mass Median Aerosol Diameter MMAD, a measure of the average
      particle size and the geometric standard deviation. It is calculated from the cumulative
      particle size curve1. The MMAD will give a reliable estimate of the likely deposition of the
      drug along the tracheo-bronchial tree. A particle size >5 will likely deposit in the upper
      airways, while particles with an MMAD of 2-5 is likely to deposit in the tracheo-bronchial
      tree2.

      Jet nebulizers are the most commonly used devices for aerosol therapy. However, the MMAD
      generated by this device is unpredictable, often leading to the drug being deposited in the
      ventilator circuit or endotracheal tube3.

      An alternative is the vibrating mesh nebulizer, which is based on a high frequency vibrating
      piezoelectric crystal. The crystal will vibrate a micron mesh at a very high frequency. A
      micro pump will deliver a small volume of liquid from a reservoir into the vibrating mesh
      resulting in a very precise aerosol generation3.

      Nebulizer therapy is often prescribed without proven effects or proper evaluation of result.
      Indeed, two large multicenter trial in acute lung injury patients were discontinued at
      interim analyses due to lack of effect4,5. This lack of effect may be due to the nebulizer
      technology (Jet nebulizer), the indication (ARDS), or primary outcome.

      The investigators would like to compare the difference in therapeutic effect between these
      two devices as this has not been published previously. It is well known that the physical
      properties of the generated aerosol may differ widely, depending on device and technology
      used. Hence, even if the same amount of drug is administered, distribution and uptake will
      not be the same. It can further be expected that the therapeutic response will be different.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change of intrinsi PPPE
time frame: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
measure: change of respioratory resistance
time frame: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
measure: change of respiratory system Compliance
time frame: 0, 5min, 60min, 6h after the first administration; 5min, 60 min and 18 h after second administration
arm group label: Aerogen
arm group type: Experimental
description: Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Aerogen
arm group label: Jet Nebulizer
arm group type: Other
description: Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet Nebulizer
intervention type: Device
intervention name: Aerogen
description: Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by mesh nebulizer
arm group label: Aerogen
intervention type: Device
intervention name: Jet nebulizer
description: Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet nebulizer
arm group label: Jet Nebulizer
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Ling Ling, Dr
role: Study Director
affiliation: Zhongda Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Ling Liu
investigator title: Dr.
mesh term: Respiratory Insufficiency
sharing ipd: No