<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/NCT03027713</url>
  </required_header>
  <id_info>
    <org_study_id>dawNAVA</org_study_id>
    <nct_id>NCT03027713</nct_id>
  </id_info>
  <brief_title>Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)</brief_title>
  <acronym>NAVA</acronym>
  <official_title>Diaphragmatic Activity During a Postoperative Rapid Weaning Protocol With Neurally Adjusted Ventilatory Assist in Healthy Lung Patients, a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación para la Investigación del Hospital Clínico de Valencia</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 purpose of this study is to describe the diaphragm electromyographic activity (Edi) in&#xD;
      healthy lung patients due to obtain a reference to guide the weaning in those patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and&#xD;
      we compared the respiratory parameters between the PSV and NAVA groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diaphragmatic electromyographic activity description</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Patients</condition>
  <arm_group>
    <arm_group_label>NAVA group with a specific catheter</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients were allocated in the NAVA weaning protocol group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSV group without a specific catheter</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>weaning protocol</intervention_name>
    <description>The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group</description>
    <arm_group_label>NAVA group with a specific catheter</arm_group_label>
    <arm_group_label>PSV group without a specific catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were scheduled for elective major surgery in which admission to the CCU&#xD;
             (critical care unit) for postoperative care and short-term mechanical ventilation with&#xD;
             rapid weaning were anticipated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative altered central nervous system, neuromuscular or lung disease and ASA&#xD;
             (american society of anesthesiologists) classification group IV or NYHA (New York&#xD;
             heart association) class IV in the case of cardiac patients. At the CCU, before&#xD;
             randomisation, we also excluded patients requiring reoperation, and those who&#xD;
             exhibited significant postsurgical bleeding, the development of myocardial infarction,&#xD;
             and hemodynamic instability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mar Garzando Civera, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación para la investigación del Hospital Clínico Universitario de Valencia</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 4, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación para la Investigación del Hospital Clínico de Valencia</investigator_affiliation>
    <investigator_full_name>F Javier Belda</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>NAVA: neurally adjusted ventilatory assist</keyword>
  <keyword>Diaphragm electromyographic activity</keyword>
  <keyword>Weaning</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Shared data will be anonymous</ipd_description>
  </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/NCT03027713
org study id: dawNAVA
nct id: NCT03027713
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in
      healthy lung patients due to obtain a reference to guide the weaning in those patients
We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and
      we compared the respiratory parameters between the PSV and NAVA groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diaphragmatic electromyographic activity description
time frame: 1 hour
arm group label: NAVA group with a specific catheter
arm group type: Other
description: The patients were allocated in the NAVA weaning protocol group
arm group label: PSV group without a specific catheter
arm group type: Other
description: The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group
intervention type: Procedure
intervention name: weaning protocol
description: The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group
arm group label: NAVA group with a specific catheter
arm group label: PSV group without a specific catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mar Garzando Civera, M.D., Ph.D.
role: Principal Investigator
affiliation: Fundación para la investigación del Hospital Clínico Universitario de Valencia
responsible party type: Principal Investigator
investigator affiliation: Fundación para la Investigación del Hospital Clínico de Valencia
investigator full name: F Javier Belda
investigator title: Prof. Dr.
sharing ipd: Yes
ipd description: Shared data will be anonymous