<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/NCT01724034</url>
  </required_header>
  <id_info>
    <org_study_id>094/2011</org_study_id>
    <nct_id>NCT01724034</nct_id>
  </id_info>
  <brief_title>Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients</brief_title>
  <acronym>WeanUS</acronym>
  <official_title>Daily Lung Ultrasound Assisting Weaning From Mechanical Ventilation in Difficult-to-wean Adult Patients - a Randomized Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Ernesto Dornelles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Moinhos de Vento</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Ernesto Dornelles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean adult&#xD;
      patients. In this randomized trial, standardized lung ultrasound will be performed daily&#xD;
      asssociated with standardized interventions aiming to decrease the total time in mechanical&#xD;
      ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will be performed in two intensive care units (ICUs). After randomization, all&#xD;
      patients in the intervention group will undergo daily lung ultrasounds before the next&#xD;
      spontaneous breathing trial. The results from the lung ultrasound will indicate specific&#xD;
      interventions to facilitate weaning:&#xD;
&#xD;
        -  No sign of lung sliding (ultrasound finding suggestive of pleural movement): prompt&#xD;
           evaluation for pneumothorax or mainstream intubation will be indicated;&#xD;
&#xD;
        -  normal lung ultrasound (ultrasound A profile): the patient will be evaluated for deep&#xD;
           vein thrombosis / pulmonary embolism and/or for reversible airway obstruction (e.g.&#xD;
           uncontrolled asthma or COPD [Chronic Obstructive Pulmonary Disease] exacerbation)-&#xD;
           followed by appropriate treatment. If the patient has COPD, non invasive mechanical&#xD;
           ventilation must be used as mode of discontinuing mechanical ventilation;&#xD;
&#xD;
        -  lung ultrasound shows pulmonary edema (ultrasound B profile): cardiogenic pulmonary&#xD;
           edema will be differentiated from acute Respiratory Distress Syndrome (ARDS) - followed&#xD;
           by appropriate treatment (e.g. a negative fluid balance of, at least, 1000 ml before the&#xD;
           next spontaneous breathing trial);&#xD;
&#xD;
        -  lung ultrasound shows asymmetrical patterns (ultrasound AB profile or Pulmonary&#xD;
           Consolidation): the possibility of an uncontrolled infection will be investigated;&#xD;
&#xD;
        -  presence of simple pleural effusion: diuretics will be indicated (for a negative fluid&#xD;
           balance of, at least, 1000 ml before the next spontaneous breathing trial) or&#xD;
           thoracocentesis at description of the assistant team;&#xD;
&#xD;
        -  presence of complex pleural effusion: other image exam will be performed, and will be&#xD;
           evaluated by the surgical team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">December 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time in mechanical ventilation</measure>
    <time_frame>from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of tracheostomies performed</measure>
    <time_frame>patients follow-up will continue until weaning from mechanical support, up to 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>from icu admition until icu discharge, up to 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ventilation-associated pneumonia</measure>
    <time_frame>until icu discharge, up to 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU's, Hospital's and 28-days mortality</measure>
    <time_frame>until ICU's and hospital's discharge and 28th day from ICU admisson, with an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance status at ICU's and Hospital's discharge</measure>
    <time_frame>at icu's and hospital discharge, with an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between findings from ultrasound and other image techniques</measure>
    <time_frame>after data collection (1 year) - retrospective review</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Weaning</measure>
    <time_frame>From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Difficult-to-wean Adult Patients</condition>
  <arm_group>
    <arm_group_label>Daily Lung Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.&#xD;
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.&#xD;
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.&#xD;
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.&#xD;
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Abolish Lung Sliding</intervention_name>
    <description>If there is no lung sliding, the patient will be promptly evaluated for pneumothorax or mainstream intubation.</description>
    <arm_group_label>Daily Lung Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Lung Ultrasound</intervention_name>
    <description>If the patient fails the spontaneous breathing trial and the lung ultrasound examination is normal - researchers will investigate venous thrombosis (deep vein thrombosis and/or pulmonary embolism) and rule out reversible airway obstruction. If the patient has the previous diagnosis of COPD, non invasive mechanical ventilation is indicated for facilitate weaning.</description>
    <arm_group_label>Daily Lung Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pulmonary Interstitial Syndrome</intervention_name>
    <description>If lung ultrasound shows &quot;B pattern&quot; - cardiogenic pulmonary edema will be differentiated from Acute Respiratory Distress Syndrome (ARDS). If cardiogenic edema is a possibility, diuretics will be administrated (at least 40 mg of furosemide) or ultrafiltration will be performed. The main target is a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to titrate vasodilators (at least a 20% reduction in the systolic blood pressure) before the next spontaneous breathing trial.</description>
    <arm_group_label>Daily Lung Ultrasound</arm_group_label>
    <other_name>B Lines</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Asymmetrical Lung Ultrasound</intervention_name>
    <description>If lung ultrasound shows asymmetrical findings, the occurence of new or uncontrolled infection (pulmonary or extrapulmonary) will be investigated.</description>
    <arm_group_label>Daily Lung Ultrasound</arm_group_label>
    <other_name>AB Profile or Consolidation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simple Pleural Effusion</intervention_name>
    <description>If the patient has pleural effusion without ultrasonographic signs of complications (any hyperechoic pattern or complex septated pattern), researchers will administrate diuretics (at least 40 mg of furosemide in 24 hours) or increase ultrafiltration - to achieve a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to perform pleural drainage.</description>
    <arm_group_label>Daily Lung Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complex Pleural Effusion</intervention_name>
    <description>If there is pleural effusion with hyperechoic or septated pattern, another image exam will be performed and evaluated by the surgical team.</description>
    <arm_group_label>Daily Lung Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Difficult to Wean;&#xD;
&#xD;
          -  1 failure in the spontaneous breathing trial or 1 extubation failure&#xD;
&#xD;
          -  Adult patients (over 18 years old);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Palliative Care;&#xD;
&#xD;
          -  Life expectancy under 90 days;&#xD;
&#xD;
          -  COPD Gold IV, Cirrhosis Child C, Metastatic Cancer with low performance, etc&#xD;
&#xD;
          -  Other weaning method than institutional protocol&#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>Felippe L Dexheimer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Ernesto Dornelles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cassiano Teixeira, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Moinhos de Vento</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paulo R Dalcin, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Felippe L Dexheimer Neto, MD</last_name>
    <phone>+555132178668</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Ernesto Dornelles</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90160-093</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Felippe L Dexheimer Neto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Ernesto Dornelles</investigator_affiliation>
    <investigator_full_name>Felippe Leopoldo Dexheimer Neto</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Weaning</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Lung Ultrasound</keyword>
  <!-- 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/NCT01724034
org study id: 094/2011
nct id: NCT01724034
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean adult
      patients. In this randomized trial, standardized lung ultrasound will be performed daily
      asssociated with standardized interventions aiming to decrease the total time in mechanical
      ventilation.
This trial will be performed in two intensive care units (ICUs). After randomization, all
      patients in the intervention group will undergo daily lung ultrasounds before the next
      spontaneous breathing trial. The results from the lung ultrasound will indicate specific
      interventions to facilitate weaning:

        -  No sign of lung sliding (ultrasound finding suggestive of pleural movement): prompt
           evaluation for pneumothorax or mainstream intubation will be indicated;

        -  normal lung ultrasound (ultrasound A profile): the patient will be evaluated for deep
           vein thrombosis / pulmonary embolism and/or for reversible airway obstruction (e.g.
           uncontrolled asthma or COPD [Chronic Obstructive Pulmonary Disease] exacerbation)-
           followed by appropriate treatment. If the patient has COPD, non invasive mechanical
           ventilation must be used as mode of discontinuing mechanical ventilation;

        -  lung ultrasound shows pulmonary edema (ultrasound B profile): cardiogenic pulmonary
           edema will be differentiated from acute Respiratory Distress Syndrome (ARDS) - followed
           by appropriate treatment (e.g. a negative fluid balance of, at least, 1000 ml before the
           next spontaneous breathing trial);

        -  lung ultrasound shows asymmetrical patterns (ultrasound AB profile or Pulmonary
           Consolidation): the possibility of an uncontrolled infection will be investigated;

        -  presence of simple pleural effusion: diuretics will be indicated (for a negative fluid
           balance of, at least, 1000 ml before the next spontaneous breathing trial) or
           thoracocentesis at description of the assistant team;

        -  presence of complex pleural effusion: other image exam will be performed, and will be
           evaluated by the surgical team.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Time in mechanical ventilation
time frame: from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days)
measure: Number of tracheostomies performed
time frame: patients follow-up will continue until weaning from mechanical support, up to 2 months
measure: Length of ICU stay
time frame: from icu admition until icu discharge, up to 2 months
measure: Incidence of ventilation-associated pneumonia
time frame: until icu discharge, up to 2 months
measure: ICU's, Hospital's and 28-days mortality
time frame: until ICU's and hospital's discharge and 28th day from ICU admisson, with an expected average of 4 weeks
measure: Performance status at ICU's and Hospital's discharge
time frame: at icu's and hospital discharge, with an expected average of 4 weeks
measure: Correlation between findings from ultrasound and other image techniques
time frame: after data collection (1 year) - retrospective review
measure: Duration of Weaning
time frame: From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks
arm group label: Daily Lung Ultrasound
arm group type: Experimental
description: If there is no lung sliding - evaluation for pneumothorax or mainstream intubation.
If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation.
If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial.
If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis.
If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.
arm group label: Control Group
arm group type: No Intervention
intervention type: Other
intervention name: Abolish Lung Sliding
description: If there is no lung sliding, the patient will be promptly evaluated for pneumothorax or mainstream intubation.
arm group label: Daily Lung Ultrasound
intervention type: Other
intervention name: Normal Lung Ultrasound
description: If the patient fails the spontaneous breathing trial and the lung ultrasound examination is normal - researchers will investigate venous thrombosis (deep vein thrombosis and/or pulmonary embolism) and rule out reversible airway obstruction. If the patient has the previous diagnosis of COPD, non invasive mechanical ventilation is indicated for facilitate weaning.
arm group label: Daily Lung Ultrasound
intervention type: Other
intervention name: Pulmonary Interstitial Syndrome
description: If lung ultrasound shows "B pattern" - cardiogenic pulmonary edema will be differentiated from Acute Respiratory Distress Syndrome (ARDS). If cardiogenic edema is a possibility, diuretics will be administrated (at least 40 mg of furosemide) or ultrafiltration will be performed. The main target is a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to titrate vasodilators (at least a 20% reduction in the systolic blood pressure) before the next spontaneous breathing trial.
arm group label: Daily Lung Ultrasound
other name: B Lines
intervention type: Other
intervention name: Asymmetrical Lung Ultrasound
description: If lung ultrasound shows asymmetrical findings, the occurence of new or uncontrolled infection (pulmonary or extrapulmonary) will be investigated.
arm group label: Daily Lung Ultrasound
other name: AB Profile or Consolidation
intervention type: Other
intervention name: Simple Pleural Effusion
description: If the patient has pleural effusion without ultrasonographic signs of complications (any hyperechoic pattern or complex septated pattern), researchers will administrate diuretics (at least 40 mg of furosemide in 24 hours) or increase ultrafiltration - to achieve a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to perform pleural drainage.
arm group label: Daily Lung Ultrasound
intervention type: Other
intervention name: Complex Pleural Effusion
description: If there is pleural effusion with hyperechoic or septated pattern, another image exam will be performed and evaluated by the surgical team.
arm group label: Daily Lung Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Felippe L Dexheimer, MD
role: Principal Investigator
affiliation: Hospital Ernesto Dornelles
last name: Cassiano Teixeira, MD, PhD
role: Study Chair
affiliation: Hospital Moinhos de Vento
last name: Paulo R Dalcin, MD, PhD
role: Study Director
affiliation: Federal University of Rio Grande do Sul
last name: Felippe L Dexheimer Neto, MD
phone: +555132178668
facility: 
status: Recruiting
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Ernesto Dornelles
investigator full name: Felippe Leopoldo Dexheimer Neto
investigator title: M.D.