<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/NCT03760510</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #170596</org_study_id>
    <nct_id>NCT03760510</nct_id>
  </id_info>
  <brief_title>Endotracheal Tube Securement Study</brief_title>
  <acronym>ETTS</acronym>
  <official_title>The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic,&#xD;
      randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube&#xD;
      fastener on complications including lip ulcers, facial skin tears, endotracheal tube&#xD;
      dislodgement, and ventilator associated pneumonia among critically ill adults requiring&#xD;
      intubation and mechanical ventilation for at least 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The optimal securement method of endotracheal tubes is unknown, but should&#xD;
      provide adequate security while minimizing complications. This study tests the hypothesis&#xD;
      that use of an endotracheal tube fastener would reduce complications among critically ill&#xD;
      adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic,&#xD;
      single center, randomized trial comparing the effect of adhesive tape versus endotracheal&#xD;
      tube fastener (Hollister) among critically ill adults requiring intubation and mechanical&#xD;
      ventilation for at least 24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 14, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The endotracheal tube securement study was a pragmatic, single center, open-label, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister AnchorFast Guard) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation</measure>
    <time_frame>48 hours post extubation up to 3 months</time_frame>
    <description>Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Lip Ulcers</measure>
    <time_frame>48 hours post extubation up to 3 months</time_frame>
    <description>Presence of lip ulcer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Facial Skin Tear</measure>
    <time_frame>48 hours post extubation up to 3 months</time_frame>
    <description>presence of facial skin tear</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Ett Dislodgement</measure>
    <time_frame>duration of intubation up to 3 months</time_frame>
    <description>frequency of ett dislodgement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Mechanical Ventilation Complication</condition>
  <arm_group>
    <arm_group_label>Adhesive Tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tube Fastener</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tube Fastener</intervention_name>
    <description>Endotrachel tube secured with tube fastener</description>
    <arm_group_label>Tube Fastener</arm_group_label>
    <other_name>Hollister AnchorFast</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adhesive Tape</intervention_name>
    <description>Endotracheal tube secured with adhesive tape.</description>
    <arm_group_label>Adhesive Tape</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient intubated prior to admission to the MICU and the intubation time was less than&#xD;
             12 hours from the time of admission&#xD;
&#xD;
          -  Patients intubated in the MICU for greater than 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intubated greater than 12 hours prior to admission to the MICU&#xD;
&#xD;
          -  presence of oral mucosa or facial skin breakdown prior to enrollment&#xD;
&#xD;
          -  required nasotracheal intubation,&#xD;
&#xD;
          -  had a documented allergy to tape&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janna Landsperger, ACNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>June 19, 2019</results_first_submitted>
  <results_first_submitted_qc>July 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 10, 2019</results_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Todd Rice</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>endotracheal tube</keyword>
  <keyword>tube fastener</keyword>
  <keyword>facial skin tear</keyword>
  <keyword>lip ulcer</keyword>
  <keyword>endotracheal tube dislodgement</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>publication in a peer-reviewed medical journal</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>March 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03760510/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Adhesive Tape</title>
          <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape&#xD;
Adhesive Tape: Endotracheal tube secured with adhesive tape.</description>
        </group>
        <group group_id="P2">
          <title>Tube Fastener</title>
          <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener&#xD;
Tube Fastener: Endotrachel tube secured with tube fastener</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="250"/>
                <participants group_id="P2" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="153"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not ventilated for 24 hours</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Eligible patients had to be intubated for at least 24 hours.</population>
      <group_list>
        <group group_id="B1">
          <title>Adhesive Tape</title>
          <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape&#xD;
Adhesive Tape: Endotracheal tube secured with adhesive tape.</description>
        </group>
        <group group_id="B2">
          <title>Tube Fastener</title>
          <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener&#xD;
Tube Fastener: Endotrachel tube secured with tube fastener</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="145"/>
            <count group_id="B2" value="153"/>
            <count group_id="B3" value="298"/>
          </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="58.5" spread="16.1"/>
                    <measurement group_id="B2" value="53.2" spread="16.4"/>
                    <measurement group_id="B3" value="55.8" spread="16.3"/>
                  </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="66"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="156"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="233"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>APACHE II</title>
          <description>Severity of Illness Score. Scores range from minimum value of 0 to maximum value of 71 points. Higher score indicates greater severity of illness.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.4" spread="8.7"/>
                    <measurement group_id="B2" value="26.0" spread="8.9"/>
                    <measurement group_id="B3" value="26.7" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation</title>
        <description>Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation</description>
        <time_frame>48 hours post extubation up to 3 months</time_frame>
        <population>Enrolled patients ventilated for at least 24 hours who had primary outcome data</population>
        <group_list>
          <group group_id="O1">
            <title>Adhesive Tape</title>
            <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape&#xD;
Adhesive Tape: Endotracheal tube secured with adhesive tape.</description>
          </group>
          <group group_id="O2">
            <title>Tube Fastener</title>
            <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener&#xD;
Tube Fastener: Endotrachel tube secured with tube fastener</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation</title>
          <description>Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation</description>
          <population>Enrolled patients ventilated for at least 24 hours who had primary outcome data</population>
          <units>events per 1000 ventilator days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.6" lower_limit="47.4" upper_limit="57.8"/>
                    <measurement group_id="O2" value="22.0" lower_limit="16.3" upper_limit="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Lip Ulcers</title>
        <description>Presence of lip ulcer</description>
        <time_frame>48 hours post extubation up to 3 months</time_frame>
        <population>Enrolled patients mechanically ventilated for at least 24 hours</population>
        <group_list>
          <group group_id="O1">
            <title>Adhesive Tape</title>
            <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape&#xD;
Adhesive Tape: Endotracheal tube secured with adhesive tape.</description>
          </group>
          <group group_id="O2">
            <title>Tube Fastener</title>
            <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener&#xD;
Tube Fastener: Endotrachel tube secured with tube fastener</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Lip Ulcers</title>
          <description>Presence of lip ulcer</description>
          <population>Enrolled patients mechanically ventilated for at least 24 hours</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="145"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Facial Skin Tear</title>
        <description>presence of facial skin tear</description>
        <time_frame>48 hours post extubation up to 3 months</time_frame>
        <population>Enrolled participants receiving mechanical ventilation for at least 24 hours</population>
        <group_list>
          <group group_id="O1">
            <title>Adhesive Tape</title>
            <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape&#xD;
Adhesive Tape: Endotracheal tube secured with adhesive tape.</description>
          </group>
          <group group_id="O2">
            <title>Tube Fastener</title>
            <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener&#xD;
Tube Fastener: Endotrachel tube secured with tube fastener</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Facial Skin Tear</title>
          <description>presence of facial skin tear</description>
          <population>Enrolled participants receiving mechanical ventilation for at least 24 hours</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="145"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Ett Dislodgement</title>
        <description>frequency of ett dislodgement</description>
        <time_frame>duration of intubation up to 3 months</time_frame>
        <population>Enrolled participants receiving mechanical ventilation for at least 24 hours</population>
        <group_list>
          <group group_id="O1">
            <title>Adhesive Tape</title>
            <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape&#xD;
Adhesive Tape: Endotracheal tube secured with adhesive tape.</description>
          </group>
          <group group_id="O2">
            <title>Tube Fastener</title>
            <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener&#xD;
Tube Fastener: Endotrachel tube secured with tube fastener</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ett Dislodgement</title>
          <description>frequency of ett dislodgement</description>
          <population>Enrolled participants receiving mechanical ventilation for at least 24 hours</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="145"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Until 48 hours after extubation</time_frame>
      <desc>Adverse events were collected prospectively and included self-extubations.</desc>
      <group_list>
        <group group_id="E1">
          <title>Adhesive Tape</title>
          <description>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape&#xD;
Adhesive Tape: Endotracheal tube secured with adhesive tape.</description>
        </group>
        <group group_id="E2">
          <title>Tube Fastener</title>
          <description>Patients in the tube fastener arm had endotrachel tube secured with tube fastener&#xD;
Tube Fastener: Endotrachel tube secured with tube fastener</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Self-Extubation</sub_title>
                <description>Patient self-extubation</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Janna Landsperger</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>6153223412</phone>
      <email>janna.landsperger@vumc.org</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/NCT03760510
org study id: IRB #170596
nct id: NCT03760510
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic,
      randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube
      fastener on complications including lip ulcers, facial skin tears, endotracheal tube
      dislodgement, and ventilator associated pneumonia among critically ill adults requiring
      intubation and mechanical ventilation for at least 24 hours.
Background: The optimal securement method of endotracheal tubes is unknown, but should
      provide adequate security while minimizing complications. This study tests the hypothesis
      that use of an endotracheal tube fastener would reduce complications among critically ill
      adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic,
      single center, randomized trial comparing the effect of adhesive tape versus endotracheal
      tube fastener (Hollister) among critically ill adults requiring intubation and mechanical
      ventilation for at least 24 hours.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The endotracheal tube securement study was a pragmatic, single center, open-label, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister AnchorFast Guard) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation
time frame: 48 hours post extubation up to 3 months
description: Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation
measure: Number of Participants With Lip Ulcers
time frame: 48 hours post extubation up to 3 months
description: Presence of lip ulcer
measure: Number of Participants With Facial Skin Tear
time frame: 48 hours post extubation up to 3 months
description: presence of facial skin tear
measure: Number of Participants With Ett Dislodgement
time frame: duration of intubation up to 3 months
description: frequency of ett dislodgement
arm group label: Adhesive Tape
arm group type: Experimental
description: Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
arm group label: Tube Fastener
arm group type: Experimental
description: Patients in the tube fastener arm had endotrachel tube secured with tube fastener
intervention type: Device
intervention name: Tube Fastener
description: Endotrachel tube secured with tube fastener
arm group label: Tube Fastener
other name: Hollister AnchorFast
intervention type: Device
intervention name: Adhesive Tape
description: Endotracheal tube secured with adhesive tape.
arm group label: Adhesive Tape
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Janna Landsperger, ACNP
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Todd Rice
investigator title: Associate Professor of Medicine
sharing ipd: No
ipd description: publication in a peer-reviewed medical journal
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 