xml: <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/NCT06011967</url>
    </required_header>
    <id_info>
      <org_study_id>E-66175679-514.04.01-788907</org_study_id>
      <nct_id>NCT06011967</nct_id>
    </id_info>
    <brief_title>Intubation With Different Angles of the Intubation Tube Using C-macr d Blade Videolaringoscope;</brief_title>
    <official_title>Intubation With Different Angles of the Intubation Tube Using C-macr d Blade Videolaringoscope; Evaluation of the Effect on Intubation Success, Subglotic Damage, and Postoperative Throat Pain: A Prospective Randomized Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yeditepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yeditepe University</source>
    <oversight_info>
      <has_dmc>No</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>
        In this study we compared the intubation success, time needed for intubation, subglottic&#xD;
        damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal&#xD;
        intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study we compared the intubation success, time needed for intubation, subglottic&#xD;
        damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal&#xD;
        intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.&#xD;
        After the approval of the Ethics Committee, patients were randomized into three groups with&#xD;
        closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90&#xD;
        degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets.&#xD;
        Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure&#xD;
        before and after intubation, time from the entrance of the laryngoscope into the mouth to the&#xD;
        passage of the vocal cords, time from the appearance of the cords to intubation,&#xD;
        Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with&#xD;
        fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and&#xD;
        hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 15, 2021</start_date>
    <completion_date type="Actual">June 13, 2022</completion_date>
    <primary_completion_date type="Actual">June 12, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>In this study we compared the intubation success, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different angled intubation stylets with C-MAC R videolaryngoscope D- blade.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>sore throat</measure>
      <time_frame>30 minutes, 4 hour, 12 hour, 24 hour</time_frame>
      <description>For evaluation of sore throat, the patients were asked whether they had any throat pain. The severity of sore throat was graded as follows: 1: no sore throat, 2: minimal, 3: moderate, 4: severe</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intubation success rate</measure>
      <time_frame>2 minutes</time_frame>
      <description>For evaluation of the success rate modified intubation difficulty score was used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subglottic damage</measure>
      <time_frame>2 hours</time_frame>
      <description>For evaluation of subglottic damage 4-point scaled subglottic damage score was used. grade 0, normal; grade 1, mucosal hyperaemia and oedema and/or slight submucosal haematoma; grade 2, moderately submucosal haematoma; grade 3, mucosal laceration and/or mucosal bleeding</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">54</enrollment>
    <condition>Intubation; Difficult or Failed</condition>
    <condition>Sore-throat</condition>
    <condition>Hoarseness</condition>
    <arm_group>
      <arm_group_label>Group A : 90 degree</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group patients were intubated using a 90 degree angled stylet with C-MAC D- Blade videolaryngoscope</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B : 80 degree</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group patients were intubated using a 80 degree angled stylet with C-MAC D- Blade videolaryngoscope</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C: 60 degree</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group patients were intubated using a 60 degree angled stylet with C-MAC D- Blade videolaryngoscope</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intubation using C-MAC D blade videolariyngoscope</intervention_name>
      <description>all patients were intubated using the C-MAC D-Blade videolaryngoscope but for each group the intubation tubes were angled in different degrees. First group was intubated using the stylet of 60 degrees, second group was intubated using the stylet of 80 degrees and the third group was intubated using the stylet of 90 degrees.</description>
      <arm_group_label>Group A : 90 degree</arm_group_label>
      <arm_group_label>Group B : 80 degree</arm_group_label>
      <arm_group_label>Group C: 60 degree</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA score I-II&#xD;
  &#xD;
            -  Elective operations&#xD;
  &#xD;
            -  Supine pozition&#xD;
  &#xD;
            -  18-65 years&#xD;
  &#xD;
            -  No history of surgery in the last 6 months&#xD;
  &#xD;
            -  No history of airway related surgery&#xD;
  &#xD;
            -  No anticipated difficult airway&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Abdomen, thorax, head-neck surgeries&#xD;
  &#xD;
            -  Smoker&#xD;
  &#xD;
            -  Chronic alcohol abuse&#xD;
  &#xD;
            -  Occupational inhaler agent exposure&#xD;
  &#xD;
            -  Patients with malignancies&#xD;
  &#xD;
            -  Patients with a history of radiotheraphy to head-neck region&#xD;
  &#xD;
            -  Patients with congenital anomalies at head-neck region&#xD;
  &#xD;
            -  Patients with diagnosed abnormalites of head -neck movements&#xD;
  &#xD;
            -  Non-cooperatied patients&#xD;
  &#xD;
            -  Non-oriented patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alkım Gizem Yılmaz Selimoğlu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yeditepe University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ferdi Menda, Prof.</last_name>
      <role>Study Director</role>
      <affiliation>yYeditepe Universitu</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Yeditepe University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Videolaryngoscope,</keyword>
    <keyword>Intubation</keyword>
    <keyword>C-MAC R Videolaryngoscope,</keyword>
    <keyword>D- Blade</keyword>
    <keyword>Subglottic damage</keyword>
    <keyword>Postoperative sore throat,</keyword>
    <keyword>Hoarsness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharyngitis</mesh_term>
      <mesh_term>Hoarseness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011967
  org study id: E-66175679-514.04.01-788907
  nct id: NCT06011967
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study we compared the intubation success, time needed for intubation, subglottic
        damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal
        intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.
  In this study we compared the intubation success, time needed for intubation, subglottic
        damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal
        intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.
        After the approval of the Ethics Committee, patients were randomized into three groups with
        closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90
        degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets.
        Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure
        before and after intubation, time from the entrance of the laryngoscope into the mouth to the
        passage of the vocal cords, time from the appearance of the cords to intubation,
        Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with
        fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and
        hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: In this study we compared the intubation success, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different angled intubation stylets with C-MAC R videolaryngoscope D- blade.
  primary purpose: Supportive Care
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: sore throat
  time frame: 30 minutes, 4 hour, 12 hour, 24 hour
  description: For evaluation of sore throat, the patients were asked whether they had any throat pain. The severity of sore throat was graded as follows: 1: no sore throat, 2: minimal, 3: moderate, 4: severe
  measure: Intubation success rate
  time frame: 2 minutes
  description: For evaluation of the success rate modified intubation difficulty score was used.
  measure: Subglottic damage
  time frame: 2 hours
  description: For evaluation of subglottic damage 4-point scaled subglottic damage score was used. grade 0, normal; grade 1, mucosal hyperaemia and oedema and/or slight submucosal haematoma; grade 2, moderately submucosal haematoma; grade 3, mucosal laceration and/or mucosal bleeding
  arm group label: Group A : 90 degree
  arm group type: Active Comparator
  description: In this group patients were intubated using a 90 degree angled stylet with C-MAC D- Blade videolaryngoscope
  arm group label: Group B : 80 degree
  arm group type: Active Comparator
  description: In this group patients were intubated using a 80 degree angled stylet with C-MAC D- Blade videolaryngoscope
  arm group label: Group C: 60 degree
  arm group type: Active Comparator
  description: In this group patients were intubated using a 60 degree angled stylet with C-MAC D- Blade videolaryngoscope
  intervention type: Other
  intervention name: Intubation using C-MAC D blade videolariyngoscope
  description: all patients were intubated using the C-MAC D-Blade videolaryngoscope but for each group the intubation tubes were angled in different degrees. First group was intubated using the stylet of 60 degrees, second group was intubated using the stylet of 80 degrees and the third group was intubated using the stylet of 90 degrees.
  arm group label: Group A : 90 degree
  arm group label: Group B : 80 degree
  arm group label: Group C: 60 degree
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alkım Gizem Yılmaz Selimoğlu
  role: Principal Investigator
  affiliation: Yeditepe University
  last name: Ferdi Menda, Prof.
  role: Study Director
  affiliation: yYeditepe Universitu
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Pharyngitis
  mesh term: Hoarseness
  sharing ipd: Undecided