<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/NCT03834597</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU R 08/2019</org_study_id>
    <nct_id>NCT03834597</nct_id>
  </id_info>
  <brief_title>GlideScope® Versus Macintosh Laryngoscope for Post-thyroidectomy Assessment of Vocal Cord Mobility</brief_title>
  <official_title>GlideScope® Versus Macintosh Laryngoscope for Post-thyroidectomy Assessment of Vocal Cord Mobility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Vocal cord dysfunction is a serious post-thyroidectomy complication. This can lead to various&#xD;
      postoperative clinical consequences as hoarseness of voice, aspiration or stridor . It is&#xD;
      also one of the common reasons for post-thyroidectomy malpractice claims.&#xD;
&#xD;
      This study will compare GlideScope® with Macintosh laryngoscope regarding accuracy of&#xD;
      assessment of post-thyroidectomy vocal cord mobility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>Vocal cord dysfunction</measure>
    <time_frame>Intraoperative</time_frame>
    <description>newly recorded reduction in the postoperative vocal cords mobility compared with the preoperative status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of traumatic complications</measure>
    <time_frame>First 24 hours postoperatively</time_frame>
    <description>traumatic complications as swelling in the mouth, tongue, or throat, teeth injury, bleeding or hoarseness of voice</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Complication, Postoperative</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>conventional Macintosh laryngoscope</intervention_name>
    <description>After closure of surgical, anesthesiologist will perform the conventional Macintosh laryngoscope to assess post-thyroidectomy vocal cord mobility.</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GlideScope®</intervention_name>
    <description>Patient will be left for a while until hemodynamic stabilization then examination with GlideScope® will be commenced to assess postthyroidectomy vocal cord mobility by another experienced anesthesiologist</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective thyroid surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I and II,&#xD;
&#xD;
          -  Elective thyroid surgery with&#xD;
&#xD;
          -  Normal thyroid profile&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous thyroid surgery,&#xD;
&#xD;
          -  Preoperative vocal cord dysfunction&#xD;
&#xD;
          -  Predicted difficult airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University hospitals</name>
      <address>
        <city>Cairo</city>
        <zip>11591</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Marwa Ahmed Khairy Elbeialy</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <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/NCT03834597
org study id: FMASU R 08/2019
nct id: NCT03834597
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Vocal cord dysfunction is a serious post-thyroidectomy complication. This can lead to various
      postoperative clinical consequences as hoarseness of voice, aspiration or stridor . It is
      also one of the common reasons for post-thyroidectomy malpractice claims.

      This study will compare GlideScope® with Macintosh laryngoscope regarding accuracy of
      assessment of post-thyroidectomy vocal cord mobility.
observational model: Cohort
time perspective: Prospective
measure: Vocal cord dysfunction
time frame: Intraoperative
description: newly recorded reduction in the postoperative vocal cords mobility compared with the preoperative status.
measure: Incidence of traumatic complications
time frame: First 24 hours postoperatively
description: traumatic complications as swelling in the mouth, tongue, or throat, teeth injury, bleeding or hoarseness of voice
intervention type: Device
intervention name: conventional Macintosh laryngoscope
description: After closure of surgical, anesthesiologist will perform the conventional Macintosh laryngoscope to assess post-thyroidectomy vocal cord mobility.
intervention type: Device
intervention name: GlideScope®
description: Patient will be left for a while until hemodynamic stabilization then examination with GlideScope® will be commenced to assess postthyroidectomy vocal cord mobility by another experienced anesthesiologist
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Marwa Ahmed Khairy Elbeialy
investigator title: Lecturer of Anesthesia
mesh term: Postoperative Complications
sharing ipd: Undecided