<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/NCT03826706</url>
  </required_header>
  <id_info>
    <org_study_id>Asozkan 4</org_study_id>
    <nct_id>NCT03826706</nct_id>
  </id_info>
  <brief_title>Comparison Of Videolaryngoscopes In Double Lumen Tube</brief_title>
  <acronym>D&amp;Xblade</acronym>
  <official_title>Comparison Of Storz C-Mac® D Blade Videolaryngoscope With McGrath® X3 Blade Videolaryngoscope In Double Lumen Tube Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu 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>
      Along with the technological advances in medicine, videolaryngoscope is the most commonly&#xD;
      preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and&#xD;
      McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation&#xD;
      patients who underwent chest surgery in terms of duration of intubation, hemodynamic response&#xD;
      and intubation-induced complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is very important for anesthesiologists to evaluate and make the airway safe in order to&#xD;
      start and continue surgical operations. Endotracheal intubation has many important reasons&#xD;
      such as ensuring airway control safely during surgical procedure, increasing the depth of&#xD;
      anesthesia, need interventions for surgical or anesthetic complications, reduction of dead&#xD;
      space, reduction of respiratory effort and prevention of aspiration risk. Videolaryngoscope,&#xD;
      developed in recent years and beginning to take place in the algorithms, facilitate difficult&#xD;
      airway management and hence intubation.&#xD;
&#xD;
      The use of videolaryngoscope in patients with intubation such as double lumen tube, has been&#xD;
      frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video&#xD;
      camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the&#xD;
      same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better&#xD;
      quality video and camera system and improves the performance of videolaryngoscope with some&#xD;
      technological changes. In this prospective controlled clinical study, the purpose is to&#xD;
      compare C-MAC videolaryngoscope with D blade and McGrath MAC videolaryngoscope with X3 blade&#xD;
      in respect to duration of intubation, haemodynamic response, and adverse events associated&#xD;
      with intubation of patients undergoing lung surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">April 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2019</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>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to intubation</measure>
    <time_frame>From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes</time_frame>
    <description>Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>From beginning of Anesthesia induction to 5th minutes of intubation</time_frame>
    <description>Heart Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Pressure</measure>
    <time_frame>At beginning of Anesthesia induction, 1st, 2nd, 3th and 5th minutes of intubation</time_frame>
    <description>Mean Arterial Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>During the first 24 hour postoperatively</time_frame>
    <description>Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Videolaryngoscopy</condition>
  <condition>Double Lumen Tube</condition>
  <condition>One-lung Ventilation</condition>
  <arm_group>
    <arm_group_label>C-MAC Videolaryngoscope D blade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients was intubated with C-MAC videolaryngoscope D blade.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>McGrath MAC Videolaryngoscope X3 blade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients was intubated with McGrath MAC Videolaryngoscope X3 blade</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>C-MAC Videolaryngoscope D blade</intervention_name>
    <description>C-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.</description>
    <arm_group_label>C-MAC Videolaryngoscope D blade</arm_group_label>
    <arm_group_label>McGrath MAC Videolaryngoscope X3 blade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>McGrath MAC Videolaryngoscope X3 blade</intervention_name>
    <description>McGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.</description>
    <arm_group_label>C-MAC Videolaryngoscope D blade</arm_group_label>
    <arm_group_label>McGrath MAC Videolaryngoscope X3 blade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology score III,&#xD;
&#xD;
          -  18-65 years,&#xD;
&#xD;
          -  BMI&gt; 40&#xD;
&#xD;
          -  Patients who was intubated with double lumen tube.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology IV,&#xD;
&#xD;
          -  Under 18 years,&#xD;
&#xD;
          -  Over 65 years,&#xD;
&#xD;
          -  Under BMI&lt;40&#xD;
&#xD;
          -  Obstetric patients,&#xD;
&#xD;
          -  Uncontrolled cerebrovascular disease,&#xD;
&#xD;
          -  Patients who refused written informed consent forms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmet Selim Ozkan</last_name>
    <role>Study Director</role>
    <affiliation>Inonu University Medical Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmet Selim Ozkan</name>
      <address>
        <city>Malatya</city>
        <zip>44310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Ahmet Selim Ozkan</investigator_full_name>
    <investigator_title>Asst. Prof. Dr. Ahmet Selim Ozkan</investigator_title>
  </responsible_party>
  <keyword>Videolaryngoscopy</keyword>
  <keyword>Double lumen tube</keyword>
  <keyword>One-lung ventilation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyrithione zinc</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03826706
org study id: Asozkan 4
nct id: NCT03826706
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Along with the technological advances in medicine, videolaryngoscope is the most commonly
      preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and
      McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation
      patients who underwent chest surgery in terms of duration of intubation, hemodynamic response
      and intubation-induced complications.
It is very important for anesthesiologists to evaluate and make the airway safe in order to
      start and continue surgical operations. Endotracheal intubation has many important reasons
      such as ensuring airway control safely during surgical procedure, increasing the depth of
      anesthesia, need interventions for surgical or anesthetic complications, reduction of dead
      space, reduction of respiratory effort and prevention of aspiration risk. Videolaryngoscope,
      developed in recent years and beginning to take place in the algorithms, facilitate difficult
      airway management and hence intubation.

      The use of videolaryngoscope in patients with intubation such as double lumen tube, has been
      frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video
      camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the
      same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better
      quality video and camera system and improves the performance of videolaryngoscope with some
      technological changes. In this prospective controlled clinical study, the purpose is to
      compare C-MAC videolaryngoscope with D blade and McGrath MAC videolaryngoscope with X3 blade
      in respect to duration of intubation, haemodynamic response, and adverse events associated
      with intubation of patients undergoing lung surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Time to intubation
time frame: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
description: Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords
measure: Heart Rate
time frame: From beginning of Anesthesia induction to 5th minutes of intubation
description: Heart Rate
measure: Mean Arterial Pressure
time frame: At beginning of Anesthesia induction, 1st, 2nd, 3th and 5th minutes of intubation
description: Mean Arterial Pressure
measure: Adverse Events
time frame: During the first 24 hour postoperatively
description: Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache
arm group label: C-MAC Videolaryngoscope D blade
arm group type: Active Comparator
description: Patients was intubated with C-MAC videolaryngoscope D blade.
arm group label: McGrath MAC Videolaryngoscope X3 blade
arm group type: Active Comparator
description: Patients was intubated with McGrath MAC Videolaryngoscope X3 blade
intervention type: Device
intervention name: C-MAC Videolaryngoscope D blade
description: C-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
arm group label: C-MAC Videolaryngoscope D blade
arm group label: McGrath MAC Videolaryngoscope X3 blade
intervention type: Device
intervention name: McGrath MAC Videolaryngoscope X3 blade
description: McGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.
arm group label: C-MAC Videolaryngoscope D blade
arm group label: McGrath MAC Videolaryngoscope X3 blade
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ahmet Selim Ozkan
role: Study Director
affiliation: Inonu University Medical Faculty
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Ahmet Selim Ozkan
investigator title: Asst. Prof. Dr. Ahmet Selim Ozkan
mesh term: Pyrithione zinc
sharing ipd: No