<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/NCT02244697</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-14-FS-0191-CTIL</org_study_id>
    <nct_id>NCT02244697</nct_id>
  </id_info>
  <brief_title>The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children</brief_title>
  <official_title>The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <brief_summary>
    <textblock>
      Stridor is a respiratory noise caused by partial obstruction of the large airways at the&#xD;
      level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal&#xD;
      cord paralysis.&#xD;
&#xD;
      Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of&#xD;
      laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient&#xD;
      and the laryngeal view may be obscured due to patient movement or anatomical variations.&#xD;
&#xD;
      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique.&#xD;
      Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability&#xD;
      in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of&#xD;
      laryngeal adduction.&#xD;
&#xD;
      The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the&#xD;
      diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL</measure>
    <time_frame>2014-2016</time_frame>
    <description>i.e. vocal cord nodules, vocal cord paralysis, vocal cord cyst etc.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stridor</condition>
  <condition>Vocal Cord Paralysis</condition>
  <arm_group>
    <arm_group_label>Experimental: laryngeal ultrasound stridor</arm_group_label>
    <description>Children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other: laryngeal ultrasound -control</arm_group_label>
    <description>Infants matched for age referred for ANL for reasons other than stridor will undergo US of the larynx.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at&#xD;
        the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US&#xD;
        of the larynx.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at&#xD;
        the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US&#xD;
        of the larynx.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirley Friedman, Doctor</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Shirley Friedman, Doctor</last_name>
    <email>shirfri@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sourasky Medical Centre</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stridor</keyword>
  <keyword>Vocal Cord Paralysis (VCP)</keyword>
  <keyword>Ultrasound (US)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysphonia</mesh_term>
    <mesh_term>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Respiratory Sounds</mesh_term>
  </condition_browse>
  <!-- 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/NCT02244697
org study id: TASMC-14-FS-0191-CTIL
nct id: NCT02244697
lead sponsor: 
Stridor is a respiratory noise caused by partial obstruction of the large airways at the
      level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal
      cord paralysis.

      Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of
      laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient
      and the laryngeal view may be obscured due to patient movement or anatomical variations.

      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique.
      Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability
      in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of
      laryngeal adduction.

      The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the
      diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric
      population.
observational model: Case-Crossover
time perspective: Prospective
measure: The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL
time frame: 2014-2016
description: i.e. vocal cord nodules, vocal cord paralysis, vocal cord cyst etc.
arm group label: Experimental: laryngeal ultrasound stridor
description: Children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre.
arm group label: Other: laryngeal ultrasound -control
description: Infants matched for age referred for ANL for reasons other than stridor will undergo US of the larynx.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
healthy volunteers: No
last name: Shirley Friedman, Doctor
role: Principal Investigator
last name: Shirley Friedman, Doctor
email: shirfri@gmail.com
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Dysphonia
mesh term: Vocal Cord Paralysis
mesh term: Paralysis
mesh term: Respiratory Sounds