<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/NCT03008174</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00080981</org_study_id>
    <nct_id>NCT03008174</nct_id>
  </id_info>
  <brief_title>Early Speech With One-Way Speaking Valve in Tracheostomy Patients</brief_title>
  <official_title>Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with tracheostomy who are on and off of mechanical ventilation initially lose the&#xD;
      ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring&#xD;
      speech in these patients. Patients with tracheostomy who experience loss of speech report&#xD;
      frustration and feelings of confinement from patients' communication impairment, therefore&#xD;
      investigators would like to restore speech in these patients as soon as it is safe to do so.&#xD;
      However, there is currently little known in the literature about the timing of the use of&#xD;
      OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test&#xD;
      clinical trial pilot study to investigate the safety of early use of OWSV in patients&#xD;
      undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit&#xD;
      from the early use of OWSV and to determine the effects of early use of OWSV on speech and&#xD;
      clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will&#xD;
      be screened, and patients meeting screening criteria will be randomized into intervention and&#xD;
      control groups. The intervention group will receive early speech-language pathology (SLP)&#xD;
      evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control&#xD;
      group will receive standard SLP evaluation and OWSV trial at 48-60 hours following&#xD;
      tracheostomy procedure. Intervention and control groups will been compared on speech and&#xD;
      clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test&#xD;
      at 48-60 hours following tracheostomy and characteristics of patients who successfully&#xD;
      tolerate early OWSV use will be identified.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2016</start_date>
  <completion_date type="Actual">December 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</measure>
    <time_frame>Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
    <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</measure>
    <time_frame>Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
    <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</measure>
    <time_frame>Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
    <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</measure>
    <time_frame>Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
    <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</measure>
    <time_frame>Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
    <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</measure>
    <time_frame>Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
    <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bleeding</measure>
    <time_frame>At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure</time_frame>
    <description>Bleeding will be reported as present or absent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bleeding</measure>
    <time_frame>At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure</time_frame>
    <description>Bleeding will be reported as present or absent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bleeding</measure>
    <time_frame>At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure</time_frame>
    <description>Bleeding will be reported as present or absent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit (ICU) Length of Stay</measure>
    <time_frame>At the time of discharge, up to 4 months</time_frame>
    <description>ICU length of stay will be reported in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>At the time of discharge, up to 4 months</time_frame>
    <description>Hospital length of stay will be reported in days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>Speech</condition>
  <condition>Aphonia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early one-way speaking valve (OWSV) assessment</intervention_name>
    <description>The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who received a percutaneous tracheostomy&#xD;
&#xD;
          -  Glasgow Coma Scale score ≥9&#xD;
&#xD;
          -  Confusion Assessment Method -ICU (CAM-ICU): negative&#xD;
&#xD;
          -  Richmond Agitation Sedation Scale (RASS): -1 to +1&#xD;
&#xD;
          -  Able to understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open tracheostomy&#xD;
&#xD;
          -  Laryngectomy&#xD;
&#xD;
          -  Presently using OWSV or capped trach&#xD;
&#xD;
          -  Foam-filled cuffed tracheostomy tube&#xD;
&#xD;
          -  Presence of known severe airway obstruction&#xD;
&#xD;
          -  Presence of post-operative bleeding requiring transfusion or packing&#xD;
&#xD;
          -  Presence of air-leak around the cuff resulting in respiratory decompensation&#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>Vinciya Pandian, PhD, MSN, ACNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920.</citation>
    <PMID>24891201</PMID>
  </reference>
  <reference>
    <citation>Mehta AB, Syeda SN, Bajpayee L, Cooke CR, Walkey AJ, Wiener RS. Trends in Tracheostomy for Mechanically Ventilated Patients in the United States, 1993-2012. Am J Respir Crit Care Med. 2015 Aug 15;192(4):446-54. doi: 10.1164/rccm.201502-0239OC.</citation>
    <PMID>25955332</PMID>
  </reference>
  <reference>
    <citation>Carroll SM. Silent, slow lifeworld: the communication experience of nonvocal ventilated patients. Qual Health Res. 2007 Nov;17(9):1165-77. doi: 10.1177/1049732307307334.</citation>
    <PMID>17968034</PMID>
  </reference>
  <reference>
    <citation>Foster A. More than nothing: the lived experience of tracheostomy while acutely ill. Intensive Crit Care Nurs. 2010 Feb;26(1):33-43. doi: 10.1016/j.iccn.2009.09.004. Epub 2009 Nov 11.</citation>
    <PMID>19910195</PMID>
  </reference>
  <reference>
    <citation>Freeman BD, Isabella K, Lin N, Buchman TG. A meta-analysis of prospective trials comparing percutaneous and surgical tracheostomy in critically ill patients. Chest. 2000 Nov;118(5):1412-8. doi: 10.1378/chest.118.5.1412.</citation>
    <PMID>11083694</PMID>
  </reference>
  <reference>
    <citation>Pandian V, Thompson CB, Feller-Kopman DJ, Mirski MA. Development and validation of a quality-of-life questionnaire for mechanically ventilated ICU patients. Crit Care Med. 2015 Jan;43(1):142-8. doi: 10.1097/CCM.0000000000000552.</citation>
    <PMID>25072754</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>December 6, 2019</results_first_submitted>
  <results_first_submitted_qc>January 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 23, 2020</results_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tracheostomy</keyword>
  <keyword>quality of life</keyword>
  <keyword>speaking valve</keyword>
  <keyword>speech</keyword>
  <keyword>mechanically ventilated patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Aphonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Will not be sharing data</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03008174/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.1" spread="19.7"/>
                    <measurement group_id="B2" value="50.6" spread="16.1"/>
                    <measurement group_id="B3" value="50.35" spread="17.48"/>
                  </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="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Middle Eastern</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sequential Organ Failure Assessment (SOFA) Score</title>
          <description>The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. SOFA scores will be reported on a scale of 0 - 24. The lower the score, the patient is not sick and the higher the score, the patient is sicker.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.6" spread="2.17"/>
                    <measurement group_id="B2" value="6.0" spread="1.63"/>
                    <measurement group_id="B3" value="5.8" spread="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</title>
        <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
        <time_frame>Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</title>
          <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
          <units>Percentage of intelligible words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.71" spread="33.35"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</title>
        <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
        <time_frame>Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</title>
          <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
          <units>Percentage of intelligible words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" spread="26.46"/>
                    <measurement group_id="O2" value="33.63" spread="33.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</title>
        <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
        <time_frame>Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
        <population>Data for this outcome measure was only obtained from participants that completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Intelligibility as Assessed by Speech Intelligibility Test Score</title>
          <description>Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).</description>
          <population>Data for this outcome measure was only obtained from participants that completed the study.</population>
          <units>Percentage of intelligible words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.54" spread="21.03"/>
                    <measurement group_id="O2" value="35.97" spread="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</title>
        <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
        <time_frame>Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</title>
          <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" spread="18.0"/>
                    <measurement group_id="O2" value="41.7" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</title>
        <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
        <time_frame>Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</title>
          <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" spread="24.8"/>
                    <measurement group_id="O2" value="47.3" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</title>
        <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
        <time_frame>Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)</time_frame>
        <population>Data for this outcome measure was only obtained from participants that completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores</title>
          <description>Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.</description>
          <population>Data for this outcome measure was only obtained from participants that completed the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0" spread="22.0"/>
                    <measurement group_id="O2" value="47.1" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bleeding</title>
        <description>Bleeding will be reported as present or absent.</description>
        <time_frame>At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bleeding</title>
          <description>Bleeding will be reported as present or absent.</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bleeding</title>
        <description>Bleeding will be reported as present or absent.</description>
        <time_frame>At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bleeding</title>
          <description>Bleeding will be reported as present or absent.</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bleeding</title>
        <description>Bleeding will be reported as present or absent.</description>
        <time_frame>At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure</time_frame>
        <population>Data for this outcome measure was only obtained from participants that completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bleeding</title>
          <description>Bleeding will be reported as present or absent.</description>
          <population>Data for this outcome measure was only obtained from participants that completed the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensive Care Unit (ICU) Length of Stay</title>
        <description>ICU length of stay will be reported in days.</description>
        <time_frame>At the time of discharge, up to 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensive Care Unit (ICU) Length of Stay</title>
          <description>ICU length of stay will be reported in days.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" spread="30.37"/>
                    <measurement group_id="O2" value="53.9" spread="51.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Hospital length of stay will be reported in days.</description>
        <time_frame>At the time of discharge, up to 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Hospital length of stay will be reported in days.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.7" spread="33.86"/>
                    <measurement group_id="O2" value="75.6" spread="101.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>21 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.&#xD;
Early one-way speaking valve (OWSV) assessment: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.&#xD;
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.</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="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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>Vinciya Pandian</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>4436553482</phone>
      <email>vpandia1@jhu.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/NCT03008174
org study id: IRB00080981
nct id: NCT03008174
lead sponsor: 
has dmc: Yes
Patients with tracheostomy who are on and off of mechanical ventilation initially lose the
      ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring
      speech in these patients. Patients with tracheostomy who experience loss of speech report
      frustration and feelings of confinement from patients' communication impairment, therefore
      investigators would like to restore speech in these patients as soon as it is safe to do so.
      However, there is currently little known in the literature about the timing of the use of
      OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test
      clinical trial pilot study to investigate the safety of early use of OWSV in patients
      undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit
      from the early use of OWSV and to determine the effects of early use of OWSV on speech and
      clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will
      be screened, and patients meeting screening criteria will be randomized into intervention and
      control groups. The intervention group will receive early speech-language pathology (SLP)
      evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control
      group will receive standard SLP evaluation and OWSV trial at 48-60 hours following
      tracheostomy procedure. Intervention and control groups will been compared on speech and
      clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test
      at 48-60 hours following tracheostomy and characteristics of patients who successfully
      tolerate early OWSV use will be identified.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Speech Intelligibility as Assessed by Speech Intelligibility Test Score
time frame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
description: Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
measure: Speech Intelligibility as Assessed by Speech Intelligibility Test Score
time frame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
description: Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
measure: Speech Intelligibility as Assessed by Speech Intelligibility Test Score
time frame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
description: Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
measure: Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
time frame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
description: Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.
measure: Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
time frame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
description: Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.
measure: Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
time frame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
description: Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.
measure: Number of Participants With Bleeding
time frame: At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure
description: Bleeding will be reported as present or absent.
measure: Number of Participants With Bleeding
time frame: At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure
description: Bleeding will be reported as present or absent.
measure: Number of Participants With Bleeding
time frame: At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure
description: Bleeding will be reported as present or absent.
measure: Intensive Care Unit (ICU) Length of Stay
time frame: At the time of discharge, up to 4 months
description: ICU length of stay will be reported in days.
measure: Hospital Length of Stay
time frame: At the time of discharge, up to 4 months
description: Hospital length of stay will be reported in days.
arm group label: Intervention
arm group type: Experimental
description: Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.
Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.
Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.
arm group label: Control
arm group type: No Intervention
description: Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.
Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.
intervention type: Other
intervention name: Early one-way speaking valve (OWSV) assessment
description: The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vinciya Pandian, PhD, MSN, ACNP
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
citation: Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920.
PMID: 24891201
citation: Mehta AB, Syeda SN, Bajpayee L, Cooke CR, Walkey AJ, Wiener RS. Trends in Tracheostomy for Mechanically Ventilated Patients in the United States, 1993-2012. Am J Respir Crit Care Med. 2015 Aug 15;192(4):446-54. doi: 10.1164/rccm.201502-0239OC.
PMID: 25955332
citation: Carroll SM. Silent, slow lifeworld: the communication experience of nonvocal ventilated patients. Qual Health Res. 2007 Nov;17(9):1165-77. doi: 10.1177/1049732307307334.
PMID: 17968034
citation: Foster A. More than nothing: the lived experience of tracheostomy while acutely ill. Intensive Crit Care Nurs. 2010 Feb;26(1):33-43. doi: 10.1016/j.iccn.2009.09.004. Epub 2009 Nov 11.
PMID: 19910195
citation: Freeman BD, Isabella K, Lin N, Buchman TG. A meta-analysis of prospective trials comparing percutaneous and surgical tracheostomy in critically ill patients. Chest. 2000 Nov;118(5):1412-8. doi: 10.1378/chest.118.5.1412.
PMID: 11083694
citation: Pandian V, Thompson CB, Feller-Kopman DJ, Mirski MA. Development and validation of a quality-of-life questionnaire for mechanically ventilated ICU patients. Crit Care Med. 2015 Jan;43(1):142-8. doi: 10.1097/CCM.0000000000000552.
PMID: 25072754
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Aphonia
sharing ipd: No
ipd description: Will not be sharing data
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 