<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/NCT02202798</url>
  </required_header>
  <id_info>
    <org_study_id>IRB13-00741</org_study_id>
    <nct_id>NCT02202798</nct_id>
  </id_info>
  <brief_title>New Devices to Measure the Intracuff Pressure</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph D. Tobias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the past 5 years, there has been a change in clinical practice with the use of cuffed&#xD;
      instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies&#xD;
      have recently introduced syringe-like devices to the market which allow the measurement of&#xD;
      the intracuff pressure. This study proposes to prospectively compare the intracuff pressure&#xD;
      from these devices with the gold standard technique (manometer).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cuff pressure</measure>
    <time_frame>One time in the OR prior to the start of surgery</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Patients Intubated With a Cuffed Endotracheal Tube</condition>
  <arm_group>
    <arm_group_label>Syringe device</arm_group_label>
    <description>Endotracheal tube cuff pressure measured by 2 new syringe devices.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Syringe device</intervention_name>
    <arm_group_label>Syringe device</arm_group_label>
    <other_name>Tru-Cuff</other_name>
    <other_name>AG Cuffill</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that are being intubated with a cuffed endotracheal tube prior to surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or younger, undergoing a procedure requiring endotracheal intubation&#xD;
             with a cuffed ETT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Joseph D. Tobias</investigator_full_name>
    <investigator_title>Chairman, Dept. of Anesthesiology &amp; Pain Medicine</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/NCT02202798
org study id: IRB13-00741
nct id: NCT02202798
lead sponsor: 
has dmc: No
Over the past 5 years, there has been a change in clinical practice with the use of cuffed
      instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies
      have recently introduced syringe-like devices to the market which allow the measurement of
      the intracuff pressure. This study proposes to prospectively compare the intracuff pressure
      from these devices with the gold standard technique (manometer).
observational model: Cohort
time perspective: Prospective
measure: Cuff pressure
time frame: One time in the OR prior to the start of surgery
arm group label: Syringe device
description: Endotracheal tube cuff pressure measured by 2 new syringe devices.
intervention type: Device
intervention name: Syringe device
arm group label: Syringe device
other name: Tru-Cuff
other name: AG Cuffill
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Joseph D. Tobias
investigator title: Chairman, Dept. of Anesthesiology & Pain Medicine