<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/NCT02218398</url>
  </required_header>
  <id_info>
    <org_study_id>BJCYRT-002</org_study_id>
    <nct_id>NCT02218398</nct_id>
  </id_info>
  <brief_title>Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients</brief_title>
  <official_title>Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients, a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators developed a test to assess the bronchodilator effects in mechanically&#xD;
      ventilated chronic obstructive pulmonary disease patients by comparing the change of airway&#xD;
      resistance. No matter whether patients respond to bronchodilator or not, they are randomized&#xD;
      assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then&#xD;
      investigators could objectively decide whether individual patients need or benefit from&#xD;
      bronchodilator administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bronchodilator is commonly used in mechanical ventilated chronic obstructive pulmonary&#xD;
      disease patients. It is assumed that patient's response to bronchodilator is the same during&#xD;
      acute exacerbation or when stable whether on mechanical ventilation or not. Decision to treat&#xD;
      is often independent of response and the patient's response to the medicine is not precisely&#xD;
      evaluated. Investigators developed a test to assess the bronchodilator effects in&#xD;
      mechanically ventilated chronic obstructive pulmonary disease patients by comparing the&#xD;
      change of airway resistance. No matter whether patients respond to bronchodilator or not,&#xD;
      they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator&#xD;
      group. Then investigators could objectively decide whether individual patients need or&#xD;
      benefit from bronchodilator administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of 12% Decrease in airway resistance</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>participants will be followed for the duration of ICU stay, an expected average of 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Bronchodilator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albuterol 3-4 times per day, steroids when necessary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No drug</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albuterol</intervention_name>
    <arm_group_label>Bronchodilator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        should meet all the criteria:&#xD;
&#xD;
          1. Acute exacerbated chronic obstructive pulmonary disease&#xD;
&#xD;
          2. Invasive mechanical ventilation with intubation outside ICU no more than 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Meet any of the criteria:&#xD;
&#xD;
          1. Asthma&#xD;
&#xD;
          2. Tracheotomy&#xD;
&#xD;
          3. Prolonged Mechanical Ventilation (Have been mechanical ventilated for more than 21&#xD;
             days)&#xD;
&#xD;
          4. Unstable hemodynamic status&#xD;
&#xD;
          5. Severe pneumonia&#xD;
&#xD;
          6. Contraindication for bronchodilator&#xD;
&#xD;
          7. Contraindication for sedation&#xD;
&#xD;
          8. Refusal to participate in study&#xD;
&#xD;
          9. Re-intubation in 48 hours&#xD;
&#xD;
         10. Mental disorder, could not understand and accomplish pulmonary function test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jie Li, Master</last_name>
    <phone>86-13552976483</phone>
    <email>lijie8497@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Respiratory Intensive Care Unit, Beijing Chaoyang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Li, Master</last_name>
      <phone>86-13552976483</phone>
      <email>lijie8497@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Bing Sun, Master</last_name>
      <phone>86-13911151075</phone>
      <email>ricusunbing@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>February 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Jie Li</investigator_full_name>
    <investigator_title>RRT-NPS</investigator_title>
  </responsible_party>
  <keyword>airway resistance</keyword>
  <keyword>lung compliance</keyword>
  <keyword>Duration of mechanical ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuterol</mesh_term>
  </intervention_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/NCT02218398
org study id: BJCYRT-002
nct id: NCT02218398
lead sponsor: 
collaborator: 
has dmc: Yes
Investigators developed a test to assess the bronchodilator effects in mechanically
      ventilated chronic obstructive pulmonary disease patients by comparing the change of airway
      resistance. No matter whether patients respond to bronchodilator or not, they are randomized
      assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then
      investigators could objectively decide whether individual patients need or benefit from
      bronchodilator administration.
Bronchodilator is commonly used in mechanical ventilated chronic obstructive pulmonary
      disease patients. It is assumed that patient's response to bronchodilator is the same during
      acute exacerbation or when stable whether on mechanical ventilation or not. Decision to treat
      is often independent of response and the patient's response to the medicine is not precisely
      evaluated. Investigators developed a test to assess the bronchodilator effects in
      mechanically ventilated chronic obstructive pulmonary disease patients by comparing the
      change of airway resistance. No matter whether patients respond to bronchodilator or not,
      they are randomized assigned to bronchodilator 3-4 times per day group and no bronchodilator
      group. Then investigators could objectively decide whether individual patients need or
      benefit from bronchodilator administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of 12% Decrease in airway resistance
time frame: 30 minutes
measure: Duration of mechanical ventilation
time frame: participants will be followed for the duration of ICU stay, an expected average of 28 days
arm group label: Bronchodilator
arm group type: Experimental
description: Albuterol 3-4 times per day, steroids when necessary.
arm group label: No drug
arm group type: No Intervention
description: No drug
intervention type: Drug
intervention name: Albuterol
arm group label: Bronchodilator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jie Li, Master
phone: 86-13552976483
email: lijie8497@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Jie Li
investigator title: RRT-NPS
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Albuterol