<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/NCT01663480</url>
  </required_header>
  <id_info>
    <org_study_id>NAVA3</org_study_id>
    <nct_id>NCT01663480</nct_id>
  </id_info>
  <brief_title>To Identify the Proportionality of Respiratory Work Under Different NAVA Level</brief_title>
  <official_title>Assessment of Patient-ventilator Breath Contribution (PVBC) During Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Acute Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ling Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of mechanical ventilation is to sufficiently unload the respiratory&#xD;
      muscles and maintain adequate ventilation in spontaneously breathing patients. When the&#xD;
      mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the&#xD;
      patient and the mechanical ventilator will contribute to the lung-distending pressure,&#xD;
      necessary to overcome inspiratory load and generate the tidal volume (Vt). Unfortunately,&#xD;
      conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory&#xD;
      assist performed by the ventilator and the patient. Inadequate levels of assist are&#xD;
      associated with adverse effects such as development of fatigue or patient-ventilator&#xD;
      dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and&#xD;
      weaning delay.&#xD;
&#xD;
      The newly introduced neurally adjusted ventilatory assist (NAVA) has made it possible to&#xD;
      measure the neural activity of the respiratory centers (expressed by the diaphragm electrical&#xD;
      activity, EAdi). EAdi is a validated variable to quantify the neural respiratory drive,&#xD;
      little is known about its usefulness to evaluate the contribution of the patient's&#xD;
      inspiratory muscle effort relative to that of the mechanical ventilator, which would be of&#xD;
      crucial importance to appropriately titrate the level of assist.&#xD;
&#xD;
      During NAVA, the patient's efficiency to transform neural effort (EAdi) into Vt, expressed as&#xD;
      neuroventilatory efficiency (NVE), may be a useful predictor for determining the contribution&#xD;
      of the patient and the ventilator to generate a breath.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PVBC index</measure>
    <time_frame>every 3 mins</time_frame>
    <description>PVBC2predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA</description>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Respiratory Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient with respiratery failure need mechinical ventilation, and will be tolerance short&#xD;
        time loe level support ventilation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:(1) Intubated or tracheostomied patients with ARF due to COPD (10&#xD;
        patients) or other reasons (10 patients) who were undergoing assisted mechanical&#xD;
        ventilation, (2) be able to tolerate short time (30 minutes) spontaneous breathing&#xD;
        (PEEP≤5cmH2O, without assist), (3) awake and do not need high dose of sedation&#xD;
&#xD;
        Exclusion Criteria:(1) age &lt;18 or &gt;80 years, (2) ready for extubation, (3) history of&#xD;
        esophageal varices, (4) gastro-esophageal surgery in the previous 12 months or&#xD;
        gastro-esophageal bleeding in the previous 30 days, (5) coagulation disorders (INR&#xD;
        ratio&gt;1.5 and APTT&gt;44 s), (6) history of acute central or peripheral nervous system&#xD;
        disorder or severe neuromuscular disease, (7) history of leukemia, severe chronic liver or&#xD;
        chronic cardiac disease, (8) solid organ transplantation, (9) malignant tumor.&#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>Haibo Qiu</last_name>
    <role>Study Director</role>
    <affiliation>southeast univerity, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southeast Univerity</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>July 2014</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Ling Liu</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT01663480
org study id: NAVA3
nct id: NCT01663480
lead sponsor: 
has dmc: Yes
The primary purpose of mechanical ventilation is to sufficiently unload the respiratory
      muscles and maintain adequate ventilation in spontaneously breathing patients. When the
      mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the
      patient and the mechanical ventilator will contribute to the lung-distending pressure,
      necessary to overcome inspiratory load and generate the tidal volume (Vt). Unfortunately,
      conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory
      assist performed by the ventilator and the patient. Inadequate levels of assist are
      associated with adverse effects such as development of fatigue or patient-ventilator
      dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and
      weaning delay.

      The newly introduced neurally adjusted ventilatory assist (NAVA) has made it possible to
      measure the neural activity of the respiratory centers (expressed by the diaphragm electrical
      activity, EAdi). EAdi is a validated variable to quantify the neural respiratory drive,
      little is known about its usefulness to evaluate the contribution of the patient's
      inspiratory muscle effort relative to that of the mechanical ventilator, which would be of
      crucial importance to appropriately titrate the level of assist.

      During NAVA, the patient's efficiency to transform neural effort (EAdi) into Vt, expressed as
      neuroventilatory efficiency (NVE), may be a useful predictor for determining the contribution
      of the patient and the ventilator to generate a breath.
observational model: Case-Only
time perspective: Prospective
measure: PVBC index
time frame: every 3 mins
description: PVBC2predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Haibo Qiu
role: Study Director
affiliation: southeast univerity, China
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Southeast University, China
investigator full name: Ling Liu
investigator title: professor
mesh term: Respiratory Insufficiency