<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/NCT01662011</url>
  </required_header>
  <id_info>
    <org_study_id>SCMC-2010001</org_study_id>
    <nct_id>NCT01662011</nct_id>
  </id_info>
  <brief_title>Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery</brief_title>
  <official_title>Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that&#xD;
      delivers ventilatory assist in proportion to neural effort. It was a controlled randomized&#xD;
      single-center prospective study in order to explore the efficacy of this new mode of&#xD;
      mechanical ventilation after corrective open-heart surgery for congenital heart disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To evaluate the effect of the patient-ventilator interaction in children underwent&#xD;
           open-heart surgery when ventilated with NAVA, compared with conventional mechanical&#xD;
           ventilation.&#xD;
&#xD;
        2. To verify the benefits of NAVA in improving the gas exchange and hemodynamics after&#xD;
           biventricle repair for CHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 3</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>Asynchrony index and Comfort Scale</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosage of sedatives</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemodynamics</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gas exchange</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Mechanical Ventilation Complication</condition>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>NAVA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients ventilated with the mode of neurally adjusted ventilatory assist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSV group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients ventilated with the mode of pressure support ventilation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mode of neurally adjusted ventilatory assist</intervention_name>
    <description>patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery</description>
    <arm_group_label>NAVA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mode of pressure support ventilation</intervention_name>
    <description>Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery</description>
    <arm_group_label>PSV group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients underwent cardiac surgery with biventricle repaired&#xD;
&#xD;
          -  patients need mechanical ventilation more than 24hrs after cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  inappositely of catheter insertion&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  coagulation disorders or bleeding&#xD;
&#xD;
          -  inclusion in other research protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Limin Zhu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Limin Zhu, MD</last_name>
    <phone>8621-38626161</phone>
    <phone_ext>6622</phone_ext>
    <email>zhulimin121@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhuoming Xu, MD PhD</last_name>
    <phone>8621-38626161</phone>
    <phone_ext>6623</phone_ext>
    <email>zmxyfb@yahoo.com.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Limin Zhu, MD</last_name>
      <phone>8621-38626161</phone>
      <phone_ext>6622</phone_ext>
      <email>zhulimin121@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhuoming Xu, MD PhD</last_name>
      <phone>8621-38626161</phone>
      <phone_ext>6623</phone_ext>
      <email>zmxyfb@yahoo.com.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 22, 2011</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Limin Zhu</investigator_full_name>
    <investigator_title>Attendant doctor, Department of thoracic and cardiovascular surgery</investigator_title>
  </responsible_party>
  <keyword>patient-ventilator interaction</keyword>
  <keyword>neurally adjusted ventilatory assist</keyword>
  <keyword>diaphragm electrical activity</keyword>
  <keyword>pressure support ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_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/NCT01662011
org study id: SCMC-2010001
nct id: NCT01662011
lead sponsor: 
has dmc: Yes
Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that
      delivers ventilatory assist in proportion to neural effort. It was a controlled randomized
      single-center prospective study in order to explore the efficacy of this new mode of
      mechanical ventilation after corrective open-heart surgery for congenital heart disease.
1. To evaluate the effect of the patient-ventilator interaction in children underwent
           open-heart surgery when ventilated with NAVA, compared with conventional mechanical
           ventilation.

        2. To verify the benefits of NAVA in improving the gas exchange and hemodynamics after
           biventricle repair for CHD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Asynchrony index and Comfort Scale
time frame: 2 weeks
measure: Dosage of sedatives
time frame: 2 weeks
measure: hemodynamics
time frame: 2 weeks
measure: Duration of mechanical ventilation
time frame: 2 weeks
measure: Gas exchange
time frame: 2 weeks
measure: Length of ICU stay
time frame: 2 weeks
arm group label: NAVA group
arm group type: Experimental
description: Patients ventilated with the mode of neurally adjusted ventilatory assist
arm group label: PSV group
arm group type: Active Comparator
description: Patients ventilated with the mode of pressure support ventilation.
intervention type: Device
intervention name: mode of neurally adjusted ventilatory assist
description: patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
arm group label: NAVA group
intervention type: Device
intervention name: Mode of pressure support ventilation
description: Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery
arm group label: PSV group
criteria: 
gender: All
minimum age: 7 Days
maximum age: 18 Years
healthy volunteers: No
last name: Limin Zhu, MD
role: Study Director
affiliation: Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
last name: Limin Zhu, MD
phone: 8621-38626161
phone ext: 6622
email: zhulimin121@hotmail.com
last name: Zhuoming Xu, MD PhD
phone: 8621-38626161
phone ext: 6623
email: zmxyfb@yahoo.com.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Limin Zhu
investigator title: Attendant doctor, Department of thoracic and cardiovascular surgery
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital