xml: <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/NCT05999526</url>
    </required_header>
    <id_info>
      <org_study_id>CHUnimed</org_study_id>
      <secondary_id>70984323.1.1001.5362</secondary_id>
      <nct_id>NCT05999526</nct_id>
    </id_info>
    <brief_title>Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial</brief_title>
    <official_title>Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial: A Randomized Controlled Feasibility Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro Hospitalar Unimed de Joinville</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centro Hospitalar Unimed de Joinville</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 aim of this study is to evaluate the feasibility to perform a future larger clinical&#xD;
        trial to analyze whether the mechanical ventilation reconnection for 1 hour after a&#xD;
        successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in&#xD;
        participants with more than 72 hours of mechanical ventilation. The study will compare two&#xD;
        weaning strategies in critically ill participants admitted to intensive care units, with more&#xD;
        than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial:&#xD;
  &#xD;
          1. Reconnection to mechanical ventilation for 1 hour followed by extubation;&#xD;
  &#xD;
          2. Direct extubation.&#xD;
  &#xD;
        Follow-up will be until hospital discharge or death.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives&#xD;
  &#xD;
        The primary objective is to evaluate the feasibility to perform a future larger clinical&#xD;
        trial to analyze whether the mechanical ventilation reconnection for 1 hour after a&#xD;
        successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in&#xD;
        participants with more than 72 hours of mechanical ventilation. Feasibility is defined as the&#xD;
        capability to complete the study according to the planned schedule and with adherence above&#xD;
        90% to the procedures of the experimental group (mechanical ventilation reconnection for 1&#xD;
        hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control&#xD;
        (extubation immediately after spontaneous breathing trial).&#xD;
  &#xD;
        Secondary objectives are to analyze the effect of mechanical ventilation reconnection for 1&#xD;
        hour after a successful spontaneous breathing trial in participants with more than 72 hours&#xD;
        of mechanical ventilation on the following outcomes: extubation failure, defined as a&#xD;
        composite criterion of reintubation or death 7 days after extubation; days free of mechanical&#xD;
        ventilation in 28 days; length of stay in the intensive care unit; length of hospital stay;&#xD;
        intensive care unit mortality; hospital mortality.&#xD;
  &#xD;
        Study design&#xD;
  &#xD;
        This is a randomized clinical trial of feasibility, open multicenter, intention-to-treat. The&#xD;
        investigators estimate the participation of 8 Brazilian intensive care units. The study will&#xD;
        compare two weaning strategies from mechanical ventilation in critically ill participants&#xD;
        admitted to intensive care units, with more than 72 hours of mechanical ventilation and with&#xD;
        a successful spontaneous breathing trial in pressure support or T-tube. Immediately following&#xD;
        a successful spontaneous breathing trial, eligible participants will be randomized to&#xD;
        mechanical ventilation reconnection for 1 hour followed by extubation or to immediate&#xD;
        extubation. Reconnection to mechanical ventilation is defined as a return to the mechanical&#xD;
        ventilation parameters prior to the spontaneous breathing trial. Follow-up will be until&#xD;
        hospital discharge or death.&#xD;
  &#xD;
        Randomization&#xD;
  &#xD;
        Participants with consent to participate in the study and who meet the inclusion criteria&#xD;
        will be randomized into two groups, which will undergo two different interventions:&#xD;
  &#xD;
          1. Reconnection to mechanical ventilation for 1 hour after successful spontaneous breathing&#xD;
             trial followed by extubation&#xD;
  &#xD;
          2. Direct extubation after successful spontaneous breathing trial&#xD;
  &#xD;
        A randomization list will be generated using a statistics package. Randomization will be in&#xD;
        blocks of variable size and stratified by center and risk of extubation failure before&#xD;
        spontaneous breathing trial. A participant who presents one or more criteria will be defined&#xD;
        as high risk for reintubation: age &gt; 65 years; presence of congestive heart failure as the&#xD;
        cause of intubation; moderate or severe chronic obstructive pulmonary disease; Acute&#xD;
        Physiology and Chronic Health Evaluation II (APACHE II) &gt; 12 or Simplified Acute Physiology&#xD;
        Score 3 (SAPS 3) &gt; 50 on the day of extubation; body mass index &gt; 30 (calculated as weight in&#xD;
        kilograms divided by height in meters squared); presence of ≥ 2 comorbidities; ineffective&#xD;
        cough or abundant secretion in the airways (&gt; 2 aspirations in 8 hours before extubation);&#xD;
        failure in more than one spontaneous breathing trial; mechanical ventilation for &gt; 7 days,&#xD;
        and; upper airway problems (including risk of developing laryngeal edema).&#xD;
  &#xD;
        Randomization will be obtained using computerized tables of random numbers in blocks of four&#xD;
        for each hospital and will be unknown to the investigators involved in participant&#xD;
        recruitment. Randomization will be centralized via the internet using appropriate software&#xD;
        (REDCap). The group to which the participant will be allocated will only be disclosed after&#xD;
        the registration of the information in the electronic system. This prevents the investigator&#xD;
        and medical staff from predicting which treatment group the participant will be allocated to.&#xD;
        In the presence of an eligible participant, assistant's physiotherapists or intensivists will&#xD;
        be directed to call a study staff member specifically responsible for randomization at each&#xD;
        center. The randomization list will be generated by a statistician who will not participate&#xD;
        in the study. As the intervention will be administered to critically ill participants on&#xD;
        mechanical ventilation, it is not necessary to blind these participants. Because it is a&#xD;
        non-pharmacological intervention, blinding the medical team is not feasible. There is no need&#xD;
        for a committee to validate the outcome of the study (feasibility) and therefore the outcome&#xD;
        evaluators will not be blinded.&#xD;
  &#xD;
        Sample calculation&#xD;
  &#xD;
        This is a study to assess feasibility with a convenience sample size of 60 participants. The&#xD;
        investigators intend to include 30 participants after pressure support spontaneous breathing&#xD;
        trial and 30 participants after T-tube spontaneous breathing trial.&#xD;
  &#xD;
        Study variables and visits&#xD;
  &#xD;
        Data will be collected by participating hospital's physiotherapist teams at bedside, recorded&#xD;
        on a case report form, and transferred to an electronic form. Researchers will be trained for&#xD;
        this specific task prior to the study. Only trained and authorized researchers will have&#xD;
        access to study forms. Participants will be followed up until death or hospital discharge.&#xD;
        For participants who are hospitalized for more than 90 days after randomization, follow-up&#xD;
        will be truncated at 90 days. In such cases, participants will be considered to have been&#xD;
        discharged alive.&#xD;
  &#xD;
        Statistical analysis&#xD;
  &#xD;
        Statistical analysis will be performed using the intention-to-treat principle. Adherence will&#xD;
        be described by means of absolute frequencies and percentages. The effect of treatment on the&#xD;
        outcome of extubation failure will be estimated using ratio of proportions and difference of&#xD;
        proportions, and respective 95% confidence intervals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>
      <intervention_model_description>Immediately after successful spontaneous breathing trial, eligible participants will be randomized into 2 groups that will undergo the following interventions:&#xD;
  Reconnection to mechanical ventilation for 1 hour: as soon as the success of the spontaneous breathing trial is confirmed, the participants will be reconnected to mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.&#xD;
  In the experimental group, in case there are signs of respiratory distress or other clinical problems during the resting phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation.&#xD;
  Direct extubation: participants will be extubated immediately after spontaneous breathing trial.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups</measure>
      <time_frame>At day of extubation</time_frame>
      <description>Defined as the capability to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental group (mechanical ventilation reconnection for 1 hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control (extubation immediately after spontaneous breathing trial).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Extubation failure within 7 days</measure>
      <time_frame>Up to 7 days after extubation</time_frame>
      <description>Defined as a composite criterion of reintubation or death 7 days after extubation; Weaning failure will be defined as failure within 7 days after extubation requiring reintubation and invasive mechanical ventilation, whether post-extubation noninvasive ventilation was used or not. The choice of the composite outcome was made to consider possible participants who die before 7 days without being reintubated.&#xD;
  The choice of time for the 7-day outcome was based on the fact that the time interval to define extubation success varies in the literature, and on the evidence that many participants are reintubated after 48-72 hours, making these times early to assess reintubation, especially in cases of prophylactic use of noninvasive ventilation or post-extubation high flow nasal cannula.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilator-free days in 28 days</measure>
      <time_frame>Up to 28 days after randomization</time_frame>
      <description>Defined as the number of days from the time of extubation and initiation of unassisted breathing to day 28 after randomization. If a participant dies before day 28, days without ventilation will be counted as zero. If a participant is reintubated and returned to mechanical ventilation and is later extubated again and remains on unassisted breathing through day 28, ventilation-free days will be counted from the end of the last assisted breathing period through day 28. One period of invasive mechanical ventilation lasting less than 24 hours and for the purposes of the surgical procedure will count as 1 day free of mechanical ventilation. Participants who are discharged from the hospital on unassisted breathing before 28 days will be considered ventilator-free for the remaining days up to 28 days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in the intensive care unit</measure>
      <time_frame>At ICU discharge, up to 90 days</time_frame>
      <description>Length of hospital stay from randomization to intensive care unit discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>At hospital discharge, up to 90 days</time_frame>
      <description>Length of hospital stay from randomization to hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality in the intensive care unit</measure>
      <time_frame>At intensive care unit discharge, up to 90 days</time_frame>
      <description>Mortality from randomization to intensive care unit discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital mortality</measure>
      <time_frame>At hospital discharge, up to 90 days</time_frame>
      <description>Mortality from randomization to hospital discharge</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Airway Extubation</condition>
    <condition>Ventilator Weaning</condition>
    <arm_group>
      <arm_group_label>Reconnection to mechanical ventilation for 1 hour</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.&#xD;
  In the experimental group, in case there are signs of respiratory distress or other clinical problems during the rest phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Direct extubation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The participant will be extubated immediately after the spontaneous breathing trial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Reconnection to mechanical ventilation for 1 hour</intervention_name>
      <description>As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.&#xD;
  In the experimental group, in case there are signs of respiratory distress or other clinical problems during the rest phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation.</description>
      <arm_group_label>Reconnection to mechanical ventilation for 1 hour</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Direct extubation</intervention_name>
      <description>The participant will be extubated immediately after the spontaneous breathing trial.</description>
      <arm_group_label>Direct extubation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years;&#xD;
  &#xD;
            -  Admission to the intensive care unit;&#xD;
  &#xD;
            -  Orotracheal intubation;&#xD;
  &#xD;
            -  Mechanical ventilation for more than 72 hours;&#xD;
  &#xD;
            -  Spontaneous breathing trial (according to the study protocol) successful and&#xD;
               considered able to be extubated.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to obey commands;&#xD;
  &#xD;
            -  Unplanned extubation;&#xD;
  &#xD;
            -  Neuromuscular disease and cervical spinal cord injury;&#xD;
  &#xD;
            -  Tracheostomy;&#xD;
  &#xD;
            -  Contraindication for cardiopulmonary resuscitation or reintubation;&#xD;
  &#xD;
            -  Absence of informed consent.&#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_contact>
      <last_name>Aline Braz Pereira</last_name>
      <phone>+55 (47) 99181-8400</phone>
      <email>linibp@hotmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centro Hospitalar Unimed de Joinville</investigator_affiliation>
      <investigator_full_name>Aline Braz Pereira</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Rest</keyword>
    <keyword>Ventilator Weaning</keyword>
    <keyword>Airway Extubation</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999526
  org study id: CHUnimed
  secondary id: 70984323.1.1001.5362
  nct id: NCT05999526
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the feasibility to perform a future larger clinical
        trial to analyze whether the mechanical ventilation reconnection for 1 hour after a
        successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in
        participants with more than 72 hours of mechanical ventilation. The study will compare two
        weaning strategies in critically ill participants admitted to intensive care units, with more
        than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial:
  
          1. Reconnection to mechanical ventilation for 1 hour followed by extubation;
  
          2. Direct extubation.
  
        Follow-up will be until hospital discharge or death.
  Objectives
  
        The primary objective is to evaluate the feasibility to perform a future larger clinical
        trial to analyze whether the mechanical ventilation reconnection for 1 hour after a
        successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in
        participants with more than 72 hours of mechanical ventilation. Feasibility is defined as the
        capability to complete the study according to the planned schedule and with adherence above
        90% to the procedures of the experimental group (mechanical ventilation reconnection for 1
        hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control
        (extubation immediately after spontaneous breathing trial).
  
        Secondary objectives are to analyze the effect of mechanical ventilation reconnection for 1
        hour after a successful spontaneous breathing trial in participants with more than 72 hours
        of mechanical ventilation on the following outcomes: extubation failure, defined as a
        composite criterion of reintubation or death 7 days after extubation; days free of mechanical
        ventilation in 28 days; length of stay in the intensive care unit; length of hospital stay;
        intensive care unit mortality; hospital mortality.
  
        Study design
  
        This is a randomized clinical trial of feasibility, open multicenter, intention-to-treat. The
        investigators estimate the participation of 8 Brazilian intensive care units. The study will
        compare two weaning strategies from mechanical ventilation in critically ill participants
        admitted to intensive care units, with more than 72 hours of mechanical ventilation and with
        a successful spontaneous breathing trial in pressure support or T-tube. Immediately following
        a successful spontaneous breathing trial, eligible participants will be randomized to
        mechanical ventilation reconnection for 1 hour followed by extubation or to immediate
        extubation. Reconnection to mechanical ventilation is defined as a return to the mechanical
        ventilation parameters prior to the spontaneous breathing trial. Follow-up will be until
        hospital discharge or death.
  
        Randomization
  
        Participants with consent to participate in the study and who meet the inclusion criteria
        will be randomized into two groups, which will undergo two different interventions:
  
          1. Reconnection to mechanical ventilation for 1 hour after successful spontaneous breathing
             trial followed by extubation
  
          2. Direct extubation after successful spontaneous breathing trial
  
        A randomization list will be generated using a statistics package. Randomization will be in
        blocks of variable size and stratified by center and risk of extubation failure before
        spontaneous breathing trial. A participant who presents one or more criteria will be defined
        as high risk for reintubation: age > 65 years; presence of congestive heart failure as the
        cause of intubation; moderate or severe chronic obstructive pulmonary disease; Acute
        Physiology and Chronic Health Evaluation II (APACHE II) > 12 or Simplified Acute Physiology
        Score 3 (SAPS 3) > 50 on the day of extubation; body mass index > 30 (calculated as weight in
        kilograms divided by height in meters squared); presence of ≥ 2 comorbidities; ineffective
        cough or abundant secretion in the airways (> 2 aspirations in 8 hours before extubation);
        failure in more than one spontaneous breathing trial; mechanical ventilation for > 7 days,
        and; upper airway problems (including risk of developing laryngeal edema).
  
        Randomization will be obtained using computerized tables of random numbers in blocks of four
        for each hospital and will be unknown to the investigators involved in participant
        recruitment. Randomization will be centralized via the internet using appropriate software
        (REDCap). The group to which the participant will be allocated will only be disclosed after
        the registration of the information in the electronic system. This prevents the investigator
        and medical staff from predicting which treatment group the participant will be allocated to.
        In the presence of an eligible participant, assistant's physiotherapists or intensivists will
        be directed to call a study staff member specifically responsible for randomization at each
        center. The randomization list will be generated by a statistician who will not participate
        in the study. As the intervention will be administered to critically ill participants on
        mechanical ventilation, it is not necessary to blind these participants. Because it is a
        non-pharmacological intervention, blinding the medical team is not feasible. There is no need
        for a committee to validate the outcome of the study (feasibility) and therefore the outcome
        evaluators will not be blinded.
  
        Sample calculation
  
        This is a study to assess feasibility with a convenience sample size of 60 participants. The
        investigators intend to include 30 participants after pressure support spontaneous breathing
        trial and 30 participants after T-tube spontaneous breathing trial.
  
        Study variables and visits
  
        Data will be collected by participating hospital's physiotherapist teams at bedside, recorded
        on a case report form, and transferred to an electronic form. Researchers will be trained for
        this specific task prior to the study. Only trained and authorized researchers will have
        access to study forms. Participants will be followed up until death or hospital discharge.
        For participants who are hospitalized for more than 90 days after randomization, follow-up
        will be truncated at 90 days. In such cases, participants will be considered to have been
        discharged alive.
  
        Statistical analysis
  
        Statistical analysis will be performed using the intention-to-treat principle. Adherence will
        be described by means of absolute frequencies and percentages. The effect of treatment on the
        outcome of extubation failure will be estimated using ratio of proportions and difference of
        proportions, and respective 95% confidence intervals.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Immediately after successful spontaneous breathing trial, eligible participants will be randomized into 2 groups that will undergo the following interventions:
  Reconnection to mechanical ventilation for 1 hour: as soon as the success of the spontaneous breathing trial is confirmed, the participants will be reconnected to mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.
  In the experimental group, in case there are signs of respiratory distress or other clinical problems during the resting phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation.
  Direct extubation: participants will be extubated immediately after spontaneous breathing trial.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups
  time frame: At day of extubation
  description: Defined as the capability to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental group (mechanical ventilation reconnection for 1 hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control (extubation immediately after spontaneous breathing trial).
  measure: Extubation failure within 7 days
  time frame: Up to 7 days after extubation
  description: Defined as a composite criterion of reintubation or death 7 days after extubation; Weaning failure will be defined as failure within 7 days after extubation requiring reintubation and invasive mechanical ventilation, whether post-extubation noninvasive ventilation was used or not. The choice of the composite outcome was made to consider possible participants who die before 7 days without being reintubated.
  The choice of time for the 7-day outcome was based on the fact that the time interval to define extubation success varies in the literature, and on the evidence that many participants are reintubated after 48-72 hours, making these times early to assess reintubation, especially in cases of prophylactic use of noninvasive ventilation or post-extubation high flow nasal cannula.
  measure: Ventilator-free days in 28 days
  time frame: Up to 28 days after randomization
  description: Defined as the number of days from the time of extubation and initiation of unassisted breathing to day 28 after randomization. If a participant dies before day 28, days without ventilation will be counted as zero. If a participant is reintubated and returned to mechanical ventilation and is later extubated again and remains on unassisted breathing through day 28, ventilation-free days will be counted from the end of the last assisted breathing period through day 28. One period of invasive mechanical ventilation lasting less than 24 hours and for the purposes of the surgical procedure will count as 1 day free of mechanical ventilation. Participants who are discharged from the hospital on unassisted breathing before 28 days will be considered ventilator-free for the remaining days up to 28 days.
  measure: Length of stay in the intensive care unit
  time frame: At ICU discharge, up to 90 days
  description: Length of hospital stay from randomization to intensive care unit discharge
  measure: Length of hospital stay
  time frame: At hospital discharge, up to 90 days
  description: Length of hospital stay from randomization to hospital discharge
  measure: Mortality in the intensive care unit
  time frame: At intensive care unit discharge, up to 90 days
  description: Mortality from randomization to intensive care unit discharge
  measure: Hospital mortality
  time frame: At hospital discharge, up to 90 days
  description: Mortality from randomization to hospital discharge
  arm group label: Reconnection to mechanical ventilation for 1 hour
  arm group type: Experimental
  description: As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.
  In the experimental group, in case there are signs of respiratory distress or other clinical problems during the rest phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation.
  arm group label: Direct extubation
  arm group type: Active Comparator
  description: The participant will be extubated immediately after the spontaneous breathing trial.
  intervention type: Other
  intervention name: Reconnection to mechanical ventilation for 1 hour
  description: As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.
  In the experimental group, in case there are signs of respiratory distress or other clinical problems during the rest phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation.
  arm group label: Reconnection to mechanical ventilation for 1 hour
  intervention type: Other
  intervention name: Direct extubation
  description: The participant will be extubated immediately after the spontaneous breathing trial.
  arm group label: Direct extubation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aline Braz Pereira
  phone: +55 (47) 99181-8400
  email: linibp@hotmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Centro Hospitalar Unimed de Joinville
  investigator full name: Aline Braz Pereira
  investigator title: Principal Investigator