<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/NCT01713010</url>
  </required_header>
  <id_info>
    <org_study_id>11212PSC002</org_study_id>
    <nct_id>NCT01713010</nct_id>
  </id_info>
  <brief_title>Study of Variables Related to the Discontinuation of Mechanical Ventilation in Patients With Head Injury</brief_title>
  <acronym>INDEXTBI</acronym>
  <official_title>Evaluation of Integrated Predictive Index of Weaning From Mechanical Ventilation in Patients With Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Uberlandia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Uberlandia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate physiological variables to the decision about the&#xD;
      appropriate time to discontinuation of mechanical ventilation in patients with traumatic&#xD;
      brain injury. It is expected that these variables are effective in predicting the outcome of&#xD;
      weaning from mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the effectiveness of integrated pressure index of airway&#xD;
      occlusion x index breathing fast and shallow (p 0.1 x f/VT) in predicting success and failure&#xD;
      of weaning from mechanical ventilation in patients with traumatic brain injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Result weaning mechanical ventilation in patients with traumatic brain injury,analyzing success and failure of weaning by 0.1 p and f / VT.</measure>
    <time_frame>8 months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Weaning Failure</condition>
  <condition>Mechanical Ventilation Complication</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Predictive indexes of weaning from mechanical ventilation</intervention_name>
    <other_name>respiratory frequency to tidal volume (f/VT)</other_name>
    <other_name>airway occlusion pressure(P0.1)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the intensive care unit with brain trauma in the process of weaning&#xD;
        from mechanical ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Traumatic Brain Injury (TBI)&#xD;
&#xD;
          -  Patients using artificial airway (intubation and / or tracheostomy)&#xD;
&#xD;
          -  Recovery from the acute phase of the disease underlying&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  Ventilation mode pressure support (PSV), pressure support (PS) required to ensure a&#xD;
             tidal volume (VT) = 6 to 8 ml / kg&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Hemoglobin &gt; 7 g/dL&#xD;
&#xD;
          -  Duration of mechanical ventilation longer than 24 hours&#xD;
&#xD;
          -  Body temperature &lt; 38 degrees&#xD;
&#xD;
          -  pH ≥ 7.30&#xD;
&#xD;
          -  PaO2 ≥ 60 mmHg with FiO2 ≤ 0.4 and PEEP ≤ 8 cmH2O&#xD;
&#xD;
          -  Glasgow Coma Scale ≥ 8 or tracheostomized&#xD;
&#xD;
          -  Sedative agents minimum dosages to to maintain values of 2 or 3 on the Ramsay Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admitted to the ICU with artificial airways held in other institutions&#xD;
&#xD;
          -  Surgery scheduled for the next 72 hours&#xD;
&#xD;
          -  Withdrawal of consent from parents at any stage of the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camila Marques Dias</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Uberlandia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Célia Regina Lopes</last_name>
    <role>Study Chair</role>
    <affiliation>Federal University of Uberlandia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>camila marques dias</last_name>
    <phone>55 34 33388655</phone>
    <email>camilamd15@yahoo.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federal University of Uberlandia</name>
      <address>
        <city>Uberlandia</city>
        <state>Minas Gerais</state>
        <zip>38408-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Camila Marques Dias</last_name>
      <phone>55 34 33388655</phone>
      <email>camilamd15@yahoo.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Uberlandia</investigator_affiliation>
    <investigator_full_name>Camila Marques Dias</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Keywords provided by Atlantic Health System:</keyword>
  <keyword>Rapid Shallow Breathing Index</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Additional relevant MeSH terms:</keyword>
  <keyword>Respiration Disorders</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Weaning Failure</keyword>
  <keyword>Mechanical ventilation complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 14, 2013</submitted>
    <returned>October 23, 2013</returned>
    <submitted>February 19, 2014</submitted>
    <returned>April 1, 2014</returned>
  </pending_results>
  <!-- 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/NCT01713010
org study id: 11212PSC002
nct id: NCT01713010
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate physiological variables to the decision about the
      appropriate time to discontinuation of mechanical ventilation in patients with traumatic
      brain injury. It is expected that these variables are effective in predicting the outcome of
      weaning from mechanical ventilation.
The aim of this study is to evaluate the effectiveness of integrated pressure index of airway
      occlusion x index breathing fast and shallow (p 0.1 x f/VT) in predicting success and failure
      of weaning from mechanical ventilation in patients with traumatic brain injury.
observational model: Case-Only
time perspective: Prospective
measure: Result weaning mechanical ventilation in patients with traumatic brain injury,analyzing success and failure of weaning by 0.1 p and f / VT.
time frame: 8 months
intervention type: Other
intervention name: Predictive indexes of weaning from mechanical ventilation
other name: respiratory frequency to tidal volume (f/VT)
other name: airway occlusion pressure(P0.1)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Camila Marques Dias
role: Principal Investigator
affiliation: Federal University of Uberlandia
last name: Célia Regina Lopes
role: Study Chair
affiliation: Federal University of Uberlandia
last name: camila marques dias
phone: 55 34 33388655
email: camilamd15@yahoo.com.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Uberlandia
investigator full name: Camila Marques Dias
investigator title: Physiotherapist
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
submitted: August 14, 2013
returned: October 23, 2013
submitted: February 19, 2014
returned: April 1, 2014