<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/NCT01697215</url>
  </required_header>
  <id_info>
    <org_study_id>111128-PIP</org_study_id>
    <nct_id>NCT01697215</nct_id>
  </id_info>
  <brief_title>Novel Device to Assess Endotracheal Tube Migration</brief_title>
  <official_title>Novel Device (AirWave™) to Assess Endotracheal Tube Migration.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <brief_summary>
    <textblock>
      To evaluate the ability of the SonarMed AirWave to provide clinicians with information that&#xD;
      enables them to confirm continuous proper placement of the endotracheal tube. This initial&#xD;
      study is prospective, observational, looking at CXR results, and comparing those to AirWave&#xD;
      system output data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Endotracheal tube displacement measured by a novel device (AirWave)</measure>
    <time_frame>within 24 hours after intubation.</time_frame>
    <description>Use of the AirWave in the study group to calculate ETT tip distance from the carina will demonstrate a strong positive correlation with chest x-rays results. Specific endpoints will include:&#xD;
• Compare CXR tube tip movement/distance to carina measurement results to AirWave tube tip movement/distance to carina calculation results (from the AirWave baseline location) within 24 hours after intubation.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Mechanically Ventilated Patients Admitted to a MICU</condition>
  <arm_group>
    <arm_group_label>Oral or nasal endotracheal intubation</arm_group_label>
    <description>Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AirWave</intervention_name>
    <arm_group_label>Oral or nasal endotracheal intubation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        MICU Based&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Subjects will be eligible for inclusion in the study if they meet ALL of the following&#xD;
        criteria:&#xD;
&#xD;
          -  Oral or nasal endotracheal intubation, anticipated to last at least 48 hours&#xD;
&#xD;
          -  Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm&#xD;
&#xD;
          -  Subject must be at least 18 years old (no upper age limitation)&#xD;
&#xD;
          -  English speaking patients/decision makers.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subjects ventilated through a tracheostomy&#xD;
&#xD;
          -  Subjects under 18 years of age&#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>Adriano Tonelli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic Foundatin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Adriano Tonelli</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01697215
org study id: 111128-PIP
nct id: NCT01697215
lead sponsor: 
To evaluate the ability of the SonarMed AirWave to provide clinicians with information that
      enables them to confirm continuous proper placement of the endotracheal tube. This initial
      study is prospective, observational, looking at CXR results, and comparing those to AirWave
      system output data.
observational model: Case-Only
time perspective: Prospective
measure: Endotracheal tube displacement measured by a novel device (AirWave)
time frame: within 24 hours after intubation.
description: Use of the AirWave in the study group to calculate ETT tip distance from the carina will demonstrate a strong positive correlation with chest x-rays results. Specific endpoints will include:
• Compare CXR tube tip movement/distance to carina measurement results to AirWave tube tip movement/distance to carina calculation results (from the AirWave baseline location) within 24 hours after intubation.
arm group label: Oral or nasal endotracheal intubation
description: Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers.
intervention type: Other
intervention name: AirWave
arm group label: Oral or nasal endotracheal intubation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adriano Tonelli, MD
role: Principal Investigator
affiliation: The Cleveland Clinic Foundatin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Adriano Tonelli
investigator title: Staff Physician