<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/NCT02184208</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P000011819</org_study_id>
    <nct_id>NCT02184208</nct_id>
  </id_info>
  <brief_title>Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System.</brief_title>
  <acronym>T3</acronym>
  <official_title>Retrospective Review of Mechanically Ventilated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic&#xD;
      monitoring are under-utilized when translating research into decision support. Current&#xD;
      medical informatic capabilities can be leveraged to calculate trends in measured parameters&#xD;
      to initiate a paradigm shift in critical care from reaction-based treatment to proactive and&#xD;
      plausibly preventative care. Therefore, the purpose of this study is to develop baseline&#xD;
      understanding of our practice and how data collection utilizing a newly implemented system&#xD;
      called T3. We would like to retrospectively review mechanically ventilated patients in which&#xD;
      we have collected continuous data to test a newly developed analytic platform. Additionally&#xD;
      we would like to compare these results to our standards of practice established by clinical&#xD;
      practice guidelines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2014</start_date>
  <completion_date type="Actual">January 9, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful Extubation</measure>
    <time_frame>Within 24 hours of extubation</time_frame>
    <description>Successful extubation without the use of noninvasive ventilation or requiring reintubation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">278</enrollment>
  <condition>Mechanical Ventilation</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Hypoxic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Device utlization following extubation</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulmonary mechanics</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All mechanically ventilated patients in our medical surgical ICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient selection will be determined by available data collected in the T3 system. We&#xD;
             estimate 50 patients in which mechanical ventilator data has been collected utilizing&#xD;
             the limited intellibridge modules (4 systems currently available to collect ventilator&#xD;
             data).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not connected to T3 data collection system.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>January 30, 2017</results_first_submitted>
  <results_first_submitted_qc>July 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2018</results_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Brian Walsh</investigator_full_name>
    <investigator_title>Research Coordinator / Research Associate</investigator_title>
  </responsible_party>
  <keyword>ARDS</keyword>
  <keyword>ALI</keyword>
  <keyword>mechanical ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patient Categorization</title>
          <description>We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="222"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patient Categorization</title>
          <description>We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="222"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" lower_limit="0.7" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Successful Extubation</title>
        <description>Successful extubation without the use of noninvasive ventilation or requiring reintubation</description>
        <time_frame>Within 24 hours of extubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Device Utlization Following Extubation</title>
            <description>The ERT score predicted device utilization</description>
          </group>
          <group group_id="O2">
            <title>Pulmonary Mechanics</title>
            <description>Heart rate (HR), respiratory rate (RR), spontaneous respiratory rate (Spont. RR) and modified ventilation index (MVI) subcategory.</description>
          </group>
        </group_list>
        <measure>
          <title>Successful Extubation</title>
          <description>Successful extubation without the use of noninvasive ventilation or requiring reintubation</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Duration of ICU stay.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Device Utlization Following Extubation</title>
          <description>Patients who were extubated were evaluated.</description>
        </group>
        <group group_id="E2">
          <title>Pulmonary Mechanics</title>
          <description>All patients on mechanical ventilation were evaluated.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="222"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="222"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="222"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Brian Kendall Walsh</name_or_title>
      <organization>Boston Children's Hospital</organization>
      <phone>617-919-3692</phone>
      <email>brian.walsh@childrens.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02184208
org study id: IRB-P000011819
nct id: NCT02184208
lead sponsor: 
has dmc: No
Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic
      monitoring are under-utilized when translating research into decision support. Current
      medical informatic capabilities can be leveraged to calculate trends in measured parameters
      to initiate a paradigm shift in critical care from reaction-based treatment to proactive and
      plausibly preventative care. Therefore, the purpose of this study is to develop baseline
      understanding of our practice and how data collection utilizing a newly implemented system
      called T3. We would like to retrospectively review mechanically ventilated patients in which
      we have collected continuous data to test a newly developed analytic platform. Additionally
      we would like to compare these results to our standards of practice established by clinical
      practice guidelines.
observational model: Cohort
time perspective: Retrospective
measure: Successful Extubation
time frame: Within 24 hours of extubation
description: Successful extubation without the use of noninvasive ventilation or requiring reintubation
arm group label: Device utlization following extubation
arm group label: Pulmonary mechanics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 35 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Brian Walsh
investigator title: Research Coordinator / Research Associate
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 