<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/NCT03764904</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU R 68 /2018</org_study_id>
    <nct_id>NCT03764904</nct_id>
  </id_info>
  <brief_title>Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery</brief_title>
  <official_title>Airway Ultrasound as a Predictor for Postextubation Stridor in Cervical Spine Surgery [Anterior Approach]: Prospective Observational Study</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>
      literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is&#xD;
      scarce.The aim of this study will be to evaluate the utility of US as an aid for decision&#xD;
      making for extubation in elective cervical spine surgery (anterior approach) operations and&#xD;
      as a predictor for postextubation stridor in these operations&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">February 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>the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor</measure>
    <time_frame>First 6 hours postoperatively</time_frame>
    <description>At the end of operation, laryngeal air column width [which is defined as the width of air between the vocal cords as demonstrated by US] will be obtained while the tube cuff is inflated then while it is deflated for three consecutive respiratory cycles after gentle suction of oropharyngeal airway. The laryngeal air-column width difference [LACWD] (the difference between width at balloon-cuff deflation and at balloon-cuff inflation) will be obtained and the average value will be recorded.&#xD;
Patient will be considered ready for extubation after performance of the cuff-leak test as [the volume of reduced cuff leak test is more than 110 ml] then reversal of neuromuscular blockade will be done. They tube will be removed when the patients can open their eyes on verbal commands and the T4/T1 ratio is 90% or more.&#xD;
After transferal of patients ICU where they will be observed for occurrence of postextubation stridor in the first 6 hour postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of other airway complication as hematoma</measure>
    <time_frame>Intraoperative pre-extubation</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Postextubation Stridor</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Airway Ultrasound</intervention_name>
    <description>Laryngeal US will be performed with a 12 megahertz (MHz) linear probe attached to the ultrasound device. With the probe placed transversely on the midline of the anterior neck over the cricothyroid membrane.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Thirty patients aged 18-60 years ASA Ⅰ and Ⅱ of both genders who are scheduled for elective&#xD;
        anterior cervical surgery under general anesthesia in supine position for the first time&#xD;
        will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgeries associated with either exposure of more than three vertebral bodies,&#xD;
&#xD;
          -  exposures involving the C2-C4 levels,&#xD;
&#xD;
          -  blood loss exceeding 300 mL&#xD;
&#xD;
          -  surgical time of more than five hours,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  laryngotracheobronchial pathology,&#xD;
&#xD;
          -  severe cardiorespiratory disease,&#xD;
&#xD;
          -  admitted for redo-surgery&#xD;
&#xD;
          -  intubated prior to operation&#xD;
&#xD;
          -  Patient with anesthetic risk factors include Mallampati 3 or 4 and multiple intubation&#xD;
             attempts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</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>Respiratory Sounds</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/NCT03764904
org study id: FMASU R 68 /2018
nct id: NCT03764904
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is
      scarce.The aim of this study will be to evaluate the utility of US as an aid for decision
      making for extubation in elective cervical spine surgery (anterior approach) operations and
      as a predictor for postextubation stridor in these operations
observational model: Cohort
time perspective: Prospective
measure: the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor
time frame: First 6 hours postoperatively
description: At the end of operation, laryngeal air column width [which is defined as the width of air between the vocal cords as demonstrated by US] will be obtained while the tube cuff is inflated then while it is deflated for three consecutive respiratory cycles after gentle suction of oropharyngeal airway. The laryngeal air-column width difference [LACWD] (the difference between width at balloon-cuff deflation and at balloon-cuff inflation) will be obtained and the average value will be recorded.
Patient will be considered ready for extubation after performance of the cuff-leak test as [the volume of reduced cuff leak test is more than 110 ml] then reversal of neuromuscular blockade will be done. They tube will be removed when the patients can open their eyes on verbal commands and the T4/T1 ratio is 90% or more.
After transferal of patients ICU where they will be observed for occurrence of postextubation stridor in the first 6 hour postoperatively.
measure: Incidence of other airway complication as hematoma
time frame: Intraoperative pre-extubation
intervention type: Radiation
intervention name: Airway Ultrasound
description: Laryngeal US will be performed with a 12 megahertz (MHz) linear probe attached to the ultrasound device. With the probe placed transversely on the midline of the anterior neck over the cricothyroid membrane.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 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: Respiratory Sounds
sharing ipd: Undecided