<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/NCT04479839</url>
  </required_header>
  <id_info>
    <org_study_id>1570971</org_study_id>
    <nct_id>NCT04479839</nct_id>
  </id_info>
  <brief_title>Point of Care Ultrasound to Confirm Endotracheal Tube Cuff Position in Relationship to the Cricoid in Pediatric Population.</brief_title>
  <official_title>Senior Atending Anesthesiologist</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidra Medical and Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidra Medical and Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part&#xD;
      of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries&#xD;
      from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the&#xD;
      cricoid in children. Previously, no clinical or imaging method has been used in real time at&#xD;
      the bedside to determine the exact location of the ETT cuff after endotracheal intubation.&#xD;
      Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of&#xD;
      visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby&#xD;
      allowing ideal ETT positioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Airway below vocal cords until the distal end of the cricoid referred to as subglottis or&#xD;
      infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal&#xD;
      tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring&#xD;
      (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various&#xD;
      modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are&#xD;
      routinely used to verify the position and the tip of the ETT in the airway, however&#xD;
      verification of the cuff position remains obscure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">September 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Visualize the saline-filled cuff of the endotracheal tube</measure>
    <time_frame>3 months</time_frame>
    <description>The primary objective was to visualize the saline-filled cuff of the endotracheal tube in relation to the cricoid and tracheal rings</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Endotracheal Tube</condition>
  <condition>Cricoid Cartilage</condition>
  <condition>Ultrasound</condition>
  <arm_group>
    <arm_group_label>Microcuff ETT</arm_group_label>
    <description>Patients intubated with microcuff ETT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-microcuff ett</arm_group_label>
    <description>Patients intubated with regular ETT</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound of the airway</intervention_name>
    <description>Placing ultrasound on the neck after intubation</description>
    <arm_group_label>Microcuff ETT</arm_group_label>
    <arm_group_label>Non-microcuff ett</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        80 children from birth to 7 years, scheduled for the surgery requiring endotracheal&#xD;
        intubation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing general anesthesia requiring endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any anatomical airway deformity or mass&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>71 Months</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tariq Wani</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attending physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidra Medicine</name>
      <address>
        <city>Doha</city>
        <zip>0000</zip>
        <country>Qatar</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Qatar</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 8, 2021</last_update_submitted>
  <last_update_submitted_qc>July 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sidra Medical and Research Center</investigator_affiliation>
    <investigator_full_name>Tariq Wani</investigator_full_name>
    <investigator_title>Senior attending</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04479839
org study id: 1570971
nct id: NCT04479839
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part
      of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries
      from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the
      cricoid in children. Previously, no clinical or imaging method has been used in real time at
      the bedside to determine the exact location of the ETT cuff after endotracheal intubation.
      Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of
      visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby
      allowing ideal ETT positioning.
Airway below vocal cords until the distal end of the cricoid referred to as subglottis or
      infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal
      tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring
      (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various
      modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are
      routinely used to verify the position and the tip of the ETT in the airway, however
      verification of the cuff position remains obscure.
observational model: Cohort
time perspective: Prospective
measure: Visualize the saline-filled cuff of the endotracheal tube
time frame: 3 months
description: The primary objective was to visualize the saline-filled cuff of the endotracheal tube in relation to the cricoid and tracheal rings
arm group label: Microcuff ETT
description: Patients intubated with microcuff ETT
arm group label: Non-microcuff ett
description: Patients intubated with regular ETT
intervention type: Diagnostic Test
intervention name: Ultrasound of the airway
description: Placing ultrasound on the neck after intubation
arm group label: Microcuff ETT
arm group label: Non-microcuff ett
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 71 Months
last name: Tariq Wani
role: Principal Investigator
affiliation: Attending physician
facility: 
country: Qatar
responsible party type: Principal Investigator
investigator affiliation: Sidra Medical and Research Center
investigator full name: Tariq Wani
investigator title: Senior attending
sharing ipd: No