<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/NCT02988167</url>
  </required_header>
  <id_info>
    <org_study_id>20160740-01H</org_study_id>
    <nct_id>NCT02988167</nct_id>
  </id_info>
  <brief_title>Introducing and Evaluating Extubation Advisor</brief_title>
  <acronym>EA</acronym>
  <official_title>Introducing and Evaluating Extubation AdvisorTM: A Pilot Phase I Observational Study of a Novel Clinical Decision Support Tool to Improve Extubation Decision-making in the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knowing when to liberate critically ill patients from mechanical ventilation (i.e.&#xD;
      extubation) is of great importance as both prolonged ventilation and failed extubation are&#xD;
      associated with increased morbidity, mortality &amp; costs. The study objective is to improve the&#xD;
      safety of extubation by harnessing hidden information contained in the patterns of variation&#xD;
      of heart and respiratory rate measured over intervals-in-time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a standard of care for patients who are intubated in the ICU; to assess ability to be&#xD;
      extubated, a Spontaneous Breathing Trial (SBT) is performed, where the level of ventilator&#xD;
      support is reduced, and patient's response is observed to predict if they will tolerate&#xD;
      extubation.&#xD;
&#xD;
      Spontaneous breathing trials (SBTs) are standard of care in assessing extubation readiness;&#xD;
      however, there are no universally accepted guidelines regarding their precise performance and&#xD;
      reporting.&#xD;
&#xD;
      Given that health is associated with a high degree of variation of physiologic parameters&#xD;
      (e.g. heart and respiratory rate), and illness &amp; stress are associated with a loss of&#xD;
      variability, the investigators have demonstrated that maintaining a high level of heart rate&#xD;
      (HRV) and respiratory rate variability (RRV) prior to and throughout the Spontaneous&#xD;
      Breathing Trial (SBT) will predict successful extubation, and a reduction in heart rate (HRV)&#xD;
      and respiratory rate variability (RRV) predicts extubation failure.&#xD;
&#xD;
      Research to date has already demonstrated the added prognostic value and the investigators&#xD;
      have derived a predictive model based on continuous monitoring of respiratory rate&#xD;
      variability (RRV). The investigators are now poised to evaluate Extubation Advisor (EA)&#xD;
      software with the overall goal to transform monitoring and improve care.&#xD;
&#xD;
      This study is a mixed methods, pilot phase I observational study of the clinical&#xD;
      implementation of a novel clinical decision support product, Extubation Advisor.TM In this&#xD;
      study the investigators will evaluate the feedback of RTs as well as the feedback of MDs&#xD;
      post-treatment (extubation) decision.&#xD;
&#xD;
      Questionnaires will be sent to Respiratory Therapists (RT's) and Medical Doctors (MD's) to&#xD;
      solicit feedback on the electronic Spontaneous Breathing Trial (SBT) Case Report Form (CRF)&#xD;
      and the Extubation Advisor TM (EA) report. All questionnaires will be answered based on a&#xD;
      rating scale of 1-5 where 1 is unacceptable and 5 is excellent.&#xD;
&#xD;
      As this proposed study is observational and has no impact on patient care/outcomes, and to&#xD;
      avoid bias associated with requiring consent, the investigators believe this study represents&#xD;
      one of the limited circumstances under which waived consent may be permitted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">October 26, 2018</completion_date>
  <primary_completion_date type="Actual">October 26, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Introduce Extubation Advisor TM (EA)</measure>
    <time_frame>1 year</time_frame>
    <description>Introduce Extubation Advisor TM (EA) in an observational study in patients being evaluated for extubation, specifically by: (i) engaging RTs to ensure waveform (EKG, CO2) monitoring is in place during spontaneous Breathing Trials (SBTs) and enter clinical data and assessment into the EA data entry screens, (ii) providing RTs and MDs with the EA report at least 48 hours after extubation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate Respiratory Therapist (RTs) feedback on the Extubation Advisor TM (EA)</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate: quality and completeness of data elements and process of data entry, integration with existing RT clinical practice and workflow, time to completion of data entry, 48 hours post extubation/treatment decision obtain RT feedback on quality and overall impression of the report.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate Intensivist (MD) feedback on the Extubation Advisor TM (EA) Report</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate quality and completeness of report, ease of integration into existing MD clinical practice and workflow, overall impression and potential impact on decision making.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate technical feasibility of future real-time implementation of Extubation Advisor TM (EA)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">121</enrollment>
  <condition>Intubation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are being considered for extubation in the ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients who have been or are expected to be on mechanical ventilation for &gt; 48 hours&#xD;
             in total prior to extubation,&#xD;
&#xD;
          2. patients who are ready for Spontaneous Breathing Test (SBT) for assessment for&#xD;
             extubation,&#xD;
&#xD;
          3. the patients who are able to tolerate pressure support ventilation ≤ 14 cm H2O (SpO2 ≥&#xD;
             90% with FiO2 ≤ 40% and PEEP 10 ≤ cm H20,&#xD;
&#xD;
          4. patients who are hemodynamically stable (off vasopressors or on low levels of&#xD;
             vasopressors: phenylephrine &lt; 50 ug/min; norepinephrine &lt; 5 ug/min; dobutamine &lt; 5&#xD;
             ug/kg/min; milrinone&lt; 0.4 ug/kg/min),&#xD;
&#xD;
          5. patients whose neurological status is stable (no deterioration in the last 24 hrs,&#xD;
             intact respiratory drive and ICP &lt;20),&#xD;
&#xD;
          6. patients who have intact airway reflexes (adequate cough with suctioning and a gag&#xD;
             reflex), and&#xD;
&#xD;
          7. patient who are in normal sinus rhythm at the time of the SBT (no pacemaker).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who have &quot;do not re-intubate&quot; order documented on their chart or if&#xD;
             withdrawal of life support is anticipated,&#xD;
&#xD;
          2. patients who have a tracheostomy,&#xD;
&#xD;
          3. patients who suffer from known or suspected severe myopathy or neuropathy (i.e.&#xD;
             myasthenia gravis, Guillain-Barré syndrome) or quadriplegia,&#xD;
&#xD;
          4. patients who have been previously extubated during the same ICU admission.&#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>Aimee Sarti</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spontaneous Breathing Trial (SBT)</keyword>
  <keyword>Extubation Decision Support Tool</keyword>
  <keyword>Extubation</keyword>
  <keyword>Extubation Readiness</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 9, 2022</submitted>
    <submission_canceled>November 23, 2022</submission_canceled>
    <submitted>March 16, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02988167
org study id: 20160740-01H
nct id: NCT02988167
lead sponsor: 
has dmc: No
Knowing when to liberate critically ill patients from mechanical ventilation (i.e.
      extubation) is of great importance as both prolonged ventilation and failed extubation are
      associated with increased morbidity, mortality & costs. The study objective is to improve the
      safety of extubation by harnessing hidden information contained in the patterns of variation
      of heart and respiratory rate measured over intervals-in-time.
As a standard of care for patients who are intubated in the ICU; to assess ability to be
      extubated, a Spontaneous Breathing Trial (SBT) is performed, where the level of ventilator
      support is reduced, and patient's response is observed to predict if they will tolerate
      extubation.

      Spontaneous breathing trials (SBTs) are standard of care in assessing extubation readiness;
      however, there are no universally accepted guidelines regarding their precise performance and
      reporting.

      Given that health is associated with a high degree of variation of physiologic parameters
      (e.g. heart and respiratory rate), and illness & stress are associated with a loss of
      variability, the investigators have demonstrated that maintaining a high level of heart rate
      (HRV) and respiratory rate variability (RRV) prior to and throughout the Spontaneous
      Breathing Trial (SBT) will predict successful extubation, and a reduction in heart rate (HRV)
      and respiratory rate variability (RRV) predicts extubation failure.

      Research to date has already demonstrated the added prognostic value and the investigators
      have derived a predictive model based on continuous monitoring of respiratory rate
      variability (RRV). The investigators are now poised to evaluate Extubation Advisor (EA)
      software with the overall goal to transform monitoring and improve care.

      This study is a mixed methods, pilot phase I observational study of the clinical
      implementation of a novel clinical decision support product, Extubation Advisor.TM In this
      study the investigators will evaluate the feedback of RTs as well as the feedback of MDs
      post-treatment (extubation) decision.

      Questionnaires will be sent to Respiratory Therapists (RT's) and Medical Doctors (MD's) to
      solicit feedback on the electronic Spontaneous Breathing Trial (SBT) Case Report Form (CRF)
      and the Extubation Advisor TM (EA) report. All questionnaires will be answered based on a
      rating scale of 1-5 where 1 is unacceptable and 5 is excellent.

      As this proposed study is observational and has no impact on patient care/outcomes, and to
      avoid bias associated with requiring consent, the investigators believe this study represents
      one of the limited circumstances under which waived consent may be permitted.
observational model: Case-Only
time perspective: Prospective
measure: Introduce Extubation Advisor TM (EA)
time frame: 1 year
description: Introduce Extubation Advisor TM (EA) in an observational study in patients being evaluated for extubation, specifically by: (i) engaging RTs to ensure waveform (EKG, CO2) monitoring is in place during spontaneous Breathing Trials (SBTs) and enter clinical data and assessment into the EA data entry screens, (ii) providing RTs and MDs with the EA report at least 48 hours after extubation.
measure: Evaluate Respiratory Therapist (RTs) feedback on the Extubation Advisor TM (EA)
time frame: 1 year
description: Evaluate: quality and completeness of data elements and process of data entry, integration with existing RT clinical practice and workflow, time to completion of data entry, 48 hours post extubation/treatment decision obtain RT feedback on quality and overall impression of the report.
measure: Evaluate Intensivist (MD) feedback on the Extubation Advisor TM (EA) Report
time frame: 1 year
description: Evaluate quality and completeness of report, ease of integration into existing MD clinical practice and workflow, overall impression and potential impact on decision making.
measure: Evaluate technical feasibility of future real-time implementation of Extubation Advisor TM (EA)
time frame: 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aimee Sarti
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No
submitted: November 9, 2022
submission canceled: November 23, 2022
submitted: March 16, 2023