<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/NCT03789071</url>
  </required_header>
  <id_info>
    <org_study_id>1218610</org_study_id>
    <nct_id>NCT03789071</nct_id>
  </id_info>
  <brief_title>Ultrasound to Predict Difficult Airway</brief_title>
  <official_title>Evaluation of Upper Airway Ultrasound-derived Indexes as Predictors of Difficult Airway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Upper airway ultrasound is a valuable, non-invasive, simple, and portable point of care tool&#xD;
      for evaluation of the airway, even in the presence of anatomic distortion caused by pathology&#xD;
      or trauma. The ultrasound technology is being increasingly adopted in modern anesthesiology&#xD;
      practice. As early as in 1984, some authors have recommended its use to guide venous&#xD;
      cannulation, because it shortens procedural times, reduces the number of failed puncture&#xD;
      attempts, and minimizes complications. On the other hand, ultrasound-guided techniques are&#xD;
      considered the gold standard for peripheral nerve blocks.&#xD;
&#xD;
      As ultrasound becomes more widespread, it is important to for anesthesiologists to be aware&#xD;
      of the expanding applications of this technology. Current and potential future applications&#xD;
      of ultrasound in anesthesiology are wide and include regional anesthesia, neuraxial and&#xD;
      chronic pain procedures, vascular access, airway assessment, lung ultrasound, ultrasound&#xD;
      neuro-monitoring, gastric ultrasound, focused transthoracic echography, trans-esophageal&#xD;
      echocardiography and vascular Doppler flow assessment. The major disadvantage is&#xD;
      inter-observer variability, and the fact that it requires is a unique skill that requires&#xD;
      continuing training and experience to master the technology. In order to be successful with&#xD;
      this technique, it is important to develop a thorough understanding of the sonoanatomy. The&#xD;
      normal or abnormal structures need to be imaged and interpreted before any intervention.&#xD;
&#xD;
      Airway management is one of the most important tasks for anesthesiologists. Access to the&#xD;
      airway should be safe, fast and efficient. Appropriate planning is crucial to avoid morbidity&#xD;
      and mortality when difficulty is anticipated. Inability to maintain airway ventilation is a&#xD;
      life-threatening situation that may warrant emergent surgical access to prevent devastating&#xD;
      consequences. A thorough assessment of the airway is recommended to predict difficulty.&#xD;
      Multiple clinical predictors have been used in clinical practice; however, most of them are&#xD;
      associated with low predictive values. In consequence, a comprehensive airway examination&#xD;
      that incorporates both quantitative and qualitative tests increases the probability of&#xD;
      predicting difficult intubation. Regardless of the method of airway evaluation, it is&#xD;
      important to acknowledge that clinical airway assessment is not fully accurate and can&#xD;
      produce both false-negative and false-positive results.&#xD;
&#xD;
      There is a growing academic interest in the ability of ultrasound to determine airway size to&#xD;
      estimate appropriate endotracheal tube size. Ultrasound enables us to identify important&#xD;
      sonoanatomy of the upper airway including thyroid cartilage, epiglottis, cricoid cartilage,&#xD;
      cricothyroid membrane, tracheal cartilages, and esophagus. Transverse and parasagittal views&#xD;
      can help diagnose supraglottic, glottic and infraglottic airway conditions and aid the&#xD;
      anesthesiologist in airway management. Ultrasonography has brought a paradigm shift in the&#xD;
      practice of airway management. With increasing awareness, portability, accessibility and&#xD;
      further sophistication in technology, it is likely to find a place in routine airway&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ultrasound depth of the tongue</measure>
    <time_frame>10 minutes</time_frame>
    <description>With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to tongue will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of glottic visualization</measure>
    <time_frame>10 minutes</time_frame>
    <description>During laryngoscopy, percentage of glottic opening will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound depth of cricoid cartilage</measure>
    <time_frame>10 minutes</time_frame>
    <description>With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to the cricoid cartilage will be measured.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">420</enrollment>
  <condition>Difficult Intubation</condition>
  <arm_group>
    <arm_group_label>Patient scheduled for general anesthesia with intubation</arm_group_label>
    <description>Patients in this group (only group) will have clinical airway assessment and external ultrasound assessment of the airway</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>External ultrasound evaluation of the airway</intervention_name>
    <description>Patients scheduled to have surgery under general anesthesia in whom tracheal intubation is planned, will have a clinical and ultrasound assessment of the airway before surgery. Information regarding laryngoscopy in the operating room will be recorded.</description>
    <arm_group_label>Patient scheduled for general anesthesia with intubation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient scheduled for elective surgery under general anesthesia in whom tracheal intubation&#xD;
        is planned.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  Age older than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Nasal intubation&#xD;
&#xD;
          -  Intubation with fiberoptic scope or glidescope&#xD;
&#xD;
          -  Intubation without laryngoscopy&#xD;
&#xD;
          -  Awake intubation&#xD;
&#xD;
          -  Allergy to ultrasound gel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Efrain Riveros Perez, MD</last_name>
    <phone>3304074681</phone>
    <email>eriverosperez@augusta.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steffen Meiler, MD</last_name>
      <phone>706-721-3671</phone>
      <email>smeiler@augusta.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Efrain Riveros Perez, MD</investigator_full_name>
    <investigator_title>Assistant Professor. Department of Anesthesiology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03789071
org study id: 1218610
nct id: NCT03789071
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Upper airway ultrasound is a valuable, non-invasive, simple, and portable point of care tool
      for evaluation of the airway, even in the presence of anatomic distortion caused by pathology
      or trauma. The ultrasound technology is being increasingly adopted in modern anesthesiology
      practice. As early as in 1984, some authors have recommended its use to guide venous
      cannulation, because it shortens procedural times, reduces the number of failed puncture
      attempts, and minimizes complications. On the other hand, ultrasound-guided techniques are
      considered the gold standard for peripheral nerve blocks.

      As ultrasound becomes more widespread, it is important to for anesthesiologists to be aware
      of the expanding applications of this technology. Current and potential future applications
      of ultrasound in anesthesiology are wide and include regional anesthesia, neuraxial and
      chronic pain procedures, vascular access, airway assessment, lung ultrasound, ultrasound
      neuro-monitoring, gastric ultrasound, focused transthoracic echography, trans-esophageal
      echocardiography and vascular Doppler flow assessment. The major disadvantage is
      inter-observer variability, and the fact that it requires is a unique skill that requires
      continuing training and experience to master the technology. In order to be successful with
      this technique, it is important to develop a thorough understanding of the sonoanatomy. The
      normal or abnormal structures need to be imaged and interpreted before any intervention.

      Airway management is one of the most important tasks for anesthesiologists. Access to the
      airway should be safe, fast and efficient. Appropriate planning is crucial to avoid morbidity
      and mortality when difficulty is anticipated. Inability to maintain airway ventilation is a
      life-threatening situation that may warrant emergent surgical access to prevent devastating
      consequences. A thorough assessment of the airway is recommended to predict difficulty.
      Multiple clinical predictors have been used in clinical practice; however, most of them are
      associated with low predictive values. In consequence, a comprehensive airway examination
      that incorporates both quantitative and qualitative tests increases the probability of
      predicting difficult intubation. Regardless of the method of airway evaluation, it is
      important to acknowledge that clinical airway assessment is not fully accurate and can
      produce both false-negative and false-positive results.

      There is a growing academic interest in the ability of ultrasound to determine airway size to
      estimate appropriate endotracheal tube size. Ultrasound enables us to identify important
      sonoanatomy of the upper airway including thyroid cartilage, epiglottis, cricoid cartilage,
      cricothyroid membrane, tracheal cartilages, and esophagus. Transverse and parasagittal views
      can help diagnose supraglottic, glottic and infraglottic airway conditions and aid the
      anesthesiologist in airway management. Ultrasonography has brought a paradigm shift in the
      practice of airway management. With increasing awareness, portability, accessibility and
      further sophistication in technology, it is likely to find a place in routine airway
      management.
observational model: Other
time perspective: Prospective
measure: Ultrasound depth of the tongue
time frame: 10 minutes
description: With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to tongue will be measured.
measure: Degree of glottic visualization
time frame: 10 minutes
description: During laryngoscopy, percentage of glottic opening will be recorded
measure: Ultrasound depth of cricoid cartilage
time frame: 10 minutes
description: With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to the cricoid cartilage will be measured.
arm group label: Patient scheduled for general anesthesia with intubation
description: Patients in this group (only group) will have clinical airway assessment and external ultrasound assessment of the airway
intervention type: Diagnostic Test
intervention name: External ultrasound evaluation of the airway
description: Patients scheduled to have surgery under general anesthesia in whom tracheal intubation is planned, will have a clinical and ultrasound assessment of the airway before surgery. Information regarding laryngoscopy in the operating room will be recorded.
arm group label: Patient scheduled for general anesthesia with intubation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Efrain Riveros Perez, MD
phone: 3304074681
email: eriverosperez@augusta.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Augusta University
investigator full name: Efrain Riveros Perez, MD
investigator title: Assistant Professor. Department of Anesthesiology
sharing ipd: Undecided