<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/NCT02969226</url>
  </required_header>
  <id_info>
    <org_study_id>FAST-002</org_study_id>
    <nct_id>NCT02969226</nct_id>
  </id_info>
  <brief_title>The Frequency of Screening and SBT Technique Trial: The FAST Trial</brief_title>
  <official_title>The Frequency of Screening and SBT Technique Trial: The FAST Trial, A North American Weaning Collaboration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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>
      Background: The sickest patients who are admitted to an intensive care unit (ICU) often&#xD;
      require assistance with their breathing. When patients start to get better, they gradually do&#xD;
      more of the breathing and the machine does less-this is called weaning. Although ventilator&#xD;
      use saves lives, the longer it is used, the more complications can occur. Clinicians aim to&#xD;
      wean patients from ventilators in a timely and safe manner. In most ICUs, patients are&#xD;
      screened (looked at) once per day to see if they are ready to undergo a weaning test (using a&#xD;
      variety of techniques) to see if the breathing tube can be removed. Screening more than once&#xD;
      per day may allow more weaning tests to be conducted. Knowing the best way to do a weaning&#xD;
      test is important because some methods may better determine who can have the breathing tube&#xD;
      removed safely. At present, we don't know the best way to help our sickest patients to wean&#xD;
      from ventilators.&#xD;
&#xD;
      Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who&#xD;
      can take breaths on their own.&#xD;
&#xD;
      Interventions: Patients in our study will receive one type of screening and one type of&#xD;
      weaning test at random. In the 'once daily' screening groups, clinicians will screen patients&#xD;
      each morning. In the 'two or more times daily screening' groups, patients will be screened in&#xD;
      the morning, afternoon, and whenever else clinicians wish to screen. When screening criteria&#xD;
      are met, patients will undergo one of two weaning tests with low ventilator support or no&#xD;
      support.&#xD;
&#xD;
      Outcomes: The main outcome of this study will be the time for patients to be successfully&#xD;
      removed from the ventilator.&#xD;
&#xD;
      Relevance: For patients, this study will clarify the best way to remove them from ventilators&#xD;
      in a timely and safe manner. For clinicians and our health care systems, this study holds&#xD;
      promise to improve how critically ill patients are weaned from breathing machines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Goals&#xD;
&#xD;
        1. To identify the best strategy to wean patients from ventilators.&#xD;
&#xD;
        2. To fully engage patients and family members (PFM) in our trial.&#xD;
&#xD;
      Rationale: Nearly 40% of the time on invasive ventilation is spent weaning. In minimizing&#xD;
      patients' exposure to invasive ventilation, clinicians are challenged by a trade-off between&#xD;
      the complications associated with protracted ventilation and the risks [ventilator-associated&#xD;
      pneumonia (VAP), mortality] of premature, failed attempts at extubation. Although randomized&#xD;
      trials have been conducted to evaluate different screening practices and spontaneous&#xD;
      breathing trial (SBT) techniques, most trials were small, predated daily screening, and have&#xD;
      limited generalizability to the North American (NA) context where weaning involves&#xD;
      respiratory therapists (RTs) and physicians.&#xD;
&#xD;
      In a systematic review of 17 trials (n=2,434), we found that screening protocols, compared to&#xD;
      usual care, were associated with a 26% reduction in total duration of ventilation, a 70%&#xD;
      reduction in weaning time, and an 11% reduction in ICU stay. Only 1 trial (n=385) compared&#xD;
      twice daily screening to usual care and found that patients screened twice daily spent&#xD;
      significantly less time on ventilators. Once daily screening is poorly aligned with the&#xD;
      continuous care ICU environment. In our international survey, Pressure Support (PS) with&#xD;
      positive end-expiratory pressure (PEEP) and T-piece were the most commonly used SBT&#xD;
      techniques. Concerns exist that PS and T-piece SBTs may over and underestimate, respectively,&#xD;
      patients' ability to breathe after extubation. Only 1 trial (n=484) has compared T-piece and&#xD;
      PS SBTs and found no difference in outcomes. This trial was conducted in Europe, predated&#xD;
      daily screening, and was underpowered.&#xD;
&#xD;
      Design: The investigators will conduct a factorial design trial involving 760 patients in 20&#xD;
      NA ICUs.&#xD;
&#xD;
      Population: The investigators will enroll critically ill adults receiving invasive&#xD;
      ventilation for &gt; 24 hours who can initiate or trigger breaths on commonly used weaning&#xD;
      modes.&#xD;
&#xD;
      Comparators: Patients will be randomized to undergo a screening frequency (once vs. at least&#xD;
      twice daily) AND an SBT technique (T-piece vs. PS ± PEEP).&#xD;
&#xD;
      Outcomes: The primary outcome will be the time to successful extubation. Secondary outcomes&#xD;
      will include general and ventilation-specific outcomes that are important to citizens. We&#xD;
      expect that more frequent screening, regardless of SBT technique, will reduce time to&#xD;
      successful extubation.&#xD;
&#xD;
      This trial will identify the best strategy to reduce the time patients spend on ventilators&#xD;
      and in ICUs, clarify best weaning practices, enhance care delivery, and launch a new paradigm&#xD;
      of engagement into our research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 18, 2018</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</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>Factorial Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to successful extubation</measure>
    <time_frame>3-4 years</time_frame>
    <description>time from randomization to successful extubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>3-4 years</time_frame>
    <description>during index ICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital and 90 day mortality</measure>
    <time_frame>3-4 years</time_frame>
    <description>during index hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first passing an SBT</measure>
    <time_frame>3-4 years</time_frame>
    <description>from randomization to SBT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total duration of mechanical ventilation (invasive and noninvasive),</measure>
    <time_frame>3-4 years</time_frame>
    <description>time randomization to successful extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>3-4 years</time_frame>
    <description>reported from index ICU admission and randomization to index ICU discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>3-4 years</time_frame>
    <description>reported from index hospital admission and randomization to index hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of NIV after extubation</measure>
    <time_frame>3-4 years</time_frame>
    <description>Binary - yes vs no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (e.g., self-extubation, tracheostomy, reintubation, prolonged ventilation at d14 and d21, ICU readmission)</measure>
    <time_frame>3-4 years</time_frame>
    <description>binary - yes vs no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRQoL (EuroQuol EQ-5D) 6 months after randomization</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>using HRQoL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status 6 months after randomization using either the IES-R, Lawton ADL scale, or the FIM</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>using Functional status questionnaire</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">760</enrollment>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>Once daily screening + PS SBTs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, RTs will screen patients between approximately 06:00 - 08:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only PS&gt; 0 and =&lt; 8 cm H2O with PEEP&gt; 0 and =&lt; 5 cm H2O.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>At least twice daily screening + PS SBTs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm patients will be screened at a minimum between approximately 06:00 - 08:00 hours and 13:00 - 15:00 hs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team [RTs and physicians]. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only PS&gt;0 and =&lt; 8 cm H2O with PEEP&gt;0 and =&lt; 5 cm H2O.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Once daily screening + T-piece SBTs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm + PS SBT' arm, RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only T-piece (off the ventilator).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>At least twice daily screening + T-piece SBTs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. If a screening period is missed inadvertently In the 'at least twice daily + PS SBT' screening arm patients will be screened at a minimum between approximately 06:00 - 08:00 hrs and 13:00 - 15:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hours of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team (RTs and physicians). Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only T-piece (off the ventilator).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Once daily screening</intervention_name>
    <description>RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.</description>
    <arm_group_label>Once daily screening + PS SBTs</arm_group_label>
    <arm_group_label>Once daily screening + T-piece SBTs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Twice daily screening</intervention_name>
    <description>In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.</description>
    <arm_group_label>At least twice daily screening + PS SBTs</arm_group_label>
    <arm_group_label>At least twice daily screening + T-piece SBTs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PS SBTs</intervention_name>
    <description>Patients are assigned a SBT technique. All SBTs for these patients must be conducted on PS &gt;0 and =&lt; 8 cm H2O with PEEP&gt;0 and =&lt; 5 cm H2O</description>
    <arm_group_label>At least twice daily screening + PS SBTs</arm_group_label>
    <arm_group_label>Once daily screening + PS SBTs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>T-piece SBTs</intervention_name>
    <description>Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator)</description>
    <arm_group_label>At least twice daily screening + T-piece SBTs</arm_group_label>
    <arm_group_label>Once daily screening + T-piece SBTs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Receiving invasive mechanical ventilation for &gt; or = 24 hours.&#xD;
&#xD;
          2. Capable of initiating spontaneous breaths or triggering the ventilator to give a&#xD;
             breath on ventilator modes commonly used in the ICU.&#xD;
&#xD;
          3. Fractional concentration of inspired oxygen (FiO2) &lt; or = 70%.&#xD;
&#xD;
          4. Positive End-Expiratory pressure (PEEP) &lt; or = 12 cm H2O.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Brain death or expected brain death.&#xD;
&#xD;
          2. Evidence of myocardial ischemia in the 24 hour period before enrollment. Except if&#xD;
             current trend in troponin is downward AND it has been &gt; or = 24 hours since last&#xD;
             troponin peak or the patient has undergone a revascularization procedure and attending&#xD;
             physician has no concerns regarding ongoing ischemia.&#xD;
&#xD;
          3. Received continuous invasive mechanical ventilation for &gt; or = 2 weeks.&#xD;
&#xD;
          4. Tracheostomy in situ at the time of screening.&#xD;
&#xD;
          5. Receiving a sedative infusion(s) for seizures or alcohol withdrawal.&#xD;
&#xD;
          6. Require escalating doses of sedative agents.&#xD;
&#xD;
          7. Receiving neuromuscular blockers or who have known quadriplegia, paraplegia or 4 limb&#xD;
             weakness or paralysis preventing active mobilization.&#xD;
&#xD;
          8. Moribund (e.g., at imminent risk for death) or who have limitations of treatment.&#xD;
&#xD;
          9. Profound neurologic deficits (e.g., post cardiac or respiratory arrest, large&#xD;
             intracranial stroke or bleed) or Glasgow Coma Scale (GCS) &lt; or = 6.&#xD;
&#xD;
         10. Use of ventilator modes that automate SBT conduct.&#xD;
&#xD;
         11. Currently enrolled in a confounding study that includes a weaning protocol.&#xD;
&#xD;
         12. Previous enrollment in this trial.&#xD;
&#xD;
         13. Previous SBT or are already on T-piece, or CPAP alone (without PS), or PS &lt; or equal 8&#xD;
             cm H2O regardless of PEEP, or other 'SBT equivalent' settings immediately before&#xD;
             randomization.&#xD;
&#xD;
         14. Previous extubation [planned, unplanned (e.g. self, accidental)] during the same ICU&#xD;
             admission.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Burns, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Michael's Hospital (Toronto, Canada)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen Burns, MD, FRCPC</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>3567</phone_ext>
    <email>burnsk@smh.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leena Rizvi, BSc.</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>2938</phone_ext>
    <email>rizvil@smh.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Longbeach Memorial Hospital</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maged Tanios, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Keck Hospital of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Alfredo Lee Chang</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Janice Liebler</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>John Devlin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicholas Hill, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Robert Hyzy</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Gerard Criner, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Jim Kutsogiannis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Peter Dodek, MD, FRCPC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maureen Meade</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Juravinski Hospital Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Bram Rochwerg, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Deborah J Cook, MD, FRCPC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Niagara Health - St. Catharines</name>
      <address>
        <city>Niagara</city>
        <state>Ontario</state>
        <zip>L2S 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jennifer Tsang</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric Duan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ottawa General Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Andrew Seely, MD, FRCPC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leena Rizvi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Robert Cirone, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Karen Burns, MD, FRCPC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universite de Sherbooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Francois Lamontagne, MD, FRCPC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ciusss McQ</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <zip>G9A5C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ying Sia</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emmanual Charbonney</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mechanical ventilation</keyword>
  <keyword>weaning</keyword>
  <keyword>critically ill</keyword>
  <keyword>spontaneous breathing trial</keyword>
  <keyword>screening</keyword>
  <keyword>invasive ventilation</keyword>
  <keyword>SBT technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02969226
org study id: FAST-002
nct id: NCT02969226
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: The sickest patients who are admitted to an intensive care unit (ICU) often
      require assistance with their breathing. When patients start to get better, they gradually do
      more of the breathing and the machine does less-this is called weaning. Although ventilator
      use saves lives, the longer it is used, the more complications can occur. Clinicians aim to
      wean patients from ventilators in a timely and safe manner. In most ICUs, patients are
      screened (looked at) once per day to see if they are ready to undergo a weaning test (using a
      variety of techniques) to see if the breathing tube can be removed. Screening more than once
      per day may allow more weaning tests to be conducted. Knowing the best way to do a weaning
      test is important because some methods may better determine who can have the breathing tube
      removed safely. At present, we don't know the best way to help our sickest patients to wean
      from ventilators.

      Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who
      can take breaths on their own.

      Interventions: Patients in our study will receive one type of screening and one type of
      weaning test at random. In the 'once daily' screening groups, clinicians will screen patients
      each morning. In the 'two or more times daily screening' groups, patients will be screened in
      the morning, afternoon, and whenever else clinicians wish to screen. When screening criteria
      are met, patients will undergo one of two weaning tests with low ventilator support or no
      support.

      Outcomes: The main outcome of this study will be the time for patients to be successfully
      removed from the ventilator.

      Relevance: For patients, this study will clarify the best way to remove them from ventilators
      in a timely and safe manner. For clinicians and our health care systems, this study holds
      promise to improve how critically ill patients are weaned from breathing machines.
Goals

        1. To identify the best strategy to wean patients from ventilators.

        2. To fully engage patients and family members (PFM) in our trial.

      Rationale: Nearly 40% of the time on invasive ventilation is spent weaning. In minimizing
      patients' exposure to invasive ventilation, clinicians are challenged by a trade-off between
      the complications associated with protracted ventilation and the risks [ventilator-associated
      pneumonia (VAP), mortality] of premature, failed attempts at extubation. Although randomized
      trials have been conducted to evaluate different screening practices and spontaneous
      breathing trial (SBT) techniques, most trials were small, predated daily screening, and have
      limited generalizability to the North American (NA) context where weaning involves
      respiratory therapists (RTs) and physicians.

      In a systematic review of 17 trials (n=2,434), we found that screening protocols, compared to
      usual care, were associated with a 26% reduction in total duration of ventilation, a 70%
      reduction in weaning time, and an 11% reduction in ICU stay. Only 1 trial (n=385) compared
      twice daily screening to usual care and found that patients screened twice daily spent
      significantly less time on ventilators. Once daily screening is poorly aligned with the
      continuous care ICU environment. In our international survey, Pressure Support (PS) with
      positive end-expiratory pressure (PEEP) and T-piece were the most commonly used SBT
      techniques. Concerns exist that PS and T-piece SBTs may over and underestimate, respectively,
      patients' ability to breathe after extubation. Only 1 trial (n=484) has compared T-piece and
      PS SBTs and found no difference in outcomes. This trial was conducted in Europe, predated
      daily screening, and was underpowered.

      Design: The investigators will conduct a factorial design trial involving 760 patients in 20
      NA ICUs.

      Population: The investigators will enroll critically ill adults receiving invasive
      ventilation for > 24 hours who can initiate or trigger breaths on commonly used weaning
      modes.

      Comparators: Patients will be randomized to undergo a screening frequency (once vs. at least
      twice daily) AND an SBT technique (T-piece vs. PS ± PEEP).

      Outcomes: The primary outcome will be the time to successful extubation. Secondary outcomes
      will include general and ventilation-specific outcomes that are important to citizens. We
      expect that more frequent screening, regardless of SBT technique, will reduce time to
      successful extubation.

      This trial will identify the best strategy to reduce the time patients spend on ventilators
      and in ICUs, clarify best weaning practices, enhance care delivery, and launch a new paradigm
      of engagement into our research.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Time to successful extubation
time frame: 3-4 years
description: time from randomization to successful extubation
measure: ICU mortality
time frame: 3-4 years
description: during index ICU admission
measure: Hospital and 90 day mortality
time frame: 3-4 years
description: during index hospital admission
measure: Time to first passing an SBT
time frame: 3-4 years
description: from randomization to SBT
measure: Total duration of mechanical ventilation (invasive and noninvasive),
time frame: 3-4 years
description: time randomization to successful extubation
measure: ICU length of stay
time frame: 3-4 years
description: reported from index ICU admission and randomization to index ICU discharge
measure: Hospital length of stay
time frame: 3-4 years
description: reported from index hospital admission and randomization to index hospital discharge
measure: Use of NIV after extubation
time frame: 3-4 years
description: Binary - yes vs no
measure: Adverse events (e.g., self-extubation, tracheostomy, reintubation, prolonged ventilation at d14 and d21, ICU readmission)
time frame: 3-4 years
description: binary - yes vs no
measure: HRQoL (EuroQuol EQ-5D) 6 months after randomization
time frame: 6 months after randomization
description: using HRQoL questionnaire
measure: Functional status 6 months after randomization using either the IES-R, Lawton ADL scale, or the FIM
time frame: 6 months after randomization
description: using Functional status questionnaire
arm group label: Once daily screening + PS SBTs
arm group type: Active Comparator
description: In this arm, RTs will screen patients between approximately 06:00 - 08:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only PS> 0 and =< 8 cm H2O with PEEP> 0 and =< 5 cm H2O.
arm group label: At least twice daily screening + PS SBTs
arm group type: Experimental
description: In this arm patients will be screened at a minimum between approximately 06:00 - 08:00 hours and 13:00 - 15:00 hs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team [RTs and physicians]. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only PS>0 and =< 8 cm H2O with PEEP>0 and =< 5 cm H2O.
arm group label: Once daily screening + T-piece SBTs
arm group type: Active Comparator
description: In this arm + PS SBT' arm, RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only T-piece (off the ventilator).
arm group label: At least twice daily screening + T-piece SBTs
arm group type: Active Comparator
description: In this arm, RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. If a screening period is missed inadvertently In the 'at least twice daily + PS SBT' screening arm patients will be screened at a minimum between approximately 06:00 - 08:00 hrs and 13:00 - 15:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hours of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team (RTs and physicians). Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only T-piece (off the ventilator).
intervention type: Procedure
intervention name: Once daily screening
description: RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.
arm group label: Once daily screening + PS SBTs
arm group label: Once daily screening + T-piece SBTs
intervention type: Procedure
intervention name: Twice daily screening
description: In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.
arm group label: At least twice daily screening + PS SBTs
arm group label: At least twice daily screening + T-piece SBTs
intervention type: Procedure
intervention name: PS SBTs
description: Patients are assigned a SBT technique. All SBTs for these patients must be conducted on PS >0 and =< 8 cm H2O with PEEP>0 and =< 5 cm H2O
arm group label: At least twice daily screening + PS SBTs
arm group label: Once daily screening + PS SBTs
intervention type: Procedure
intervention name: T-piece SBTs
description: Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator)
arm group label: At least twice daily screening + T-piece SBTs
arm group label: Once daily screening + T-piece SBTs
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Karen Burns, MD, FRCPC
role: Principal Investigator
affiliation: St. Michael's Hospital (Toronto, Canada)
last name: Karen Burns, MD, FRCPC
phone: 416-864-6060
phone ext: 3567
email: burnsk@smh.ca
last name: Leena Rizvi, BSc.
phone: 416-864-6060
phone ext: 2938
email: rizvil@smh.ca
facility: 
status: Recruiting
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status: Not yet recruiting
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No