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/NCT05988736</url>
    </required_header>
    <id_info>
      <org_study_id>2022-7215-21602</org_study_id>
      <nct_id>NCT05988736</nct_id>
    </id_info>
    <brief_title>Comparison Between McGrath and Macintosh Laryngoscopes for DLT Intubation in Thoracic Surgery Patients.</brief_title>
    <official_title>Comparison Between McGrath and Macintosh Laryngoscopes for Double-lumen Tube Intubation in Patients Undergoing Thoracic Surgery, A Prospective Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aga Khan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aga Khan University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among&#xD;
        patients undergoing thoracic surgery. The main questions it aims to answer are,&#xD;
  &#xD;
          1. Rate of successful intubation at first attempt and&#xD;
  &#xD;
          2. Time for intubation required with each device. Participants are required to sign the&#xD;
             informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group&#xD;
             B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath&#xD;
             (VL) the differences in rate of successful intubation at first attempt and time for&#xD;
             intubation required with each device.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</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>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time required for correct placement of the Double Lumen Tube (DLT).</measure>
      <time_frame>During intervention time period</time_frame>
      <description>Time will be measured in seconds during laryngoscopy while placement of Double Lumen Tube (DLT) until appearance of end tidal carbon dioxide on capnograph.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Successful Intubation at first attempt.</measure>
      <time_frame>immediately after Intervention.</time_frame>
      <description>The number of times the laryngoscope will be inserted.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Thoracic Diseases</condition>
    <condition>Thoracic Neoplasms</condition>
    <condition>Thoracic Empyema</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MaCintosh Laryngoscope (DL)</intervention_name>
      <description>A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>McGrath Laryngoscope (VL)</intervention_name>
      <description>A video Laryngoscope that has a high-resolution video camera, and a light source at the cone end of the blade allowing for direct and indirect viewing of the glottis</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-65 years&#xD;
  &#xD;
            -  American Society of Anaesthesiologists physical status (ASA) I, II, III&#xD;
  &#xD;
            -  Elective thoracic surgery patients, requiring one lung ventilation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients requiring rapid sequence induction&#xD;
  &#xD;
            -  Patients with a structural problem in the airway on chest radiography&#xD;
  &#xD;
            -  History of difficult intubation&#xD;
  &#xD;
            -  Planned tracheostomy \ the presence of a tracheostomy&#xD;
  &#xD;
                 -  Patients with a BMI &gt;35 kg\m2. Who at risk of regurgitation\ Aspiration&#xD;
  &#xD;
                 -  Anticipated Difficult Airway (Mallampati IV)&#xD;
  &#xD;
                 -  Pre-existing sore throat or hoarseness, or recent respiratory infection (&lt;15&#xD;
                    days)&#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_contact>
      <last_name>sadique Wadho, MBBS</last_name>
      <phone>+923322792932</phone>
      <email>sadique.ali@aku.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Khalid Samad, MBBS, FCPS</last_name>
      <phone>+923343311603</phone>
      <email>khalid.samad@aku.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Aga Khan University Hospital</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>sadique Wadho, MBBS</last_name>
        <phone>+923322792932</phone>
        <email>sadique.ali@aku.edu</email>
      </contact>
      <contact_backup>
        <last_name>Khalid Samad, MBBS. FCPS</last_name>
        <phone>+923343311603</phone>
        <email>khalid.samad@aku.edu</email>
      </contact_backup>
      <investigator>
        <last_name>sadique Wadho, MBBS</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Khalid Samad, MBBS, FCPS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aga Khan University</investigator_affiliation>
      <investigator_full_name>Sadique Ali</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Empyema</mesh_term>
      <mesh_term>Empyema, Pleural</mesh_term>
      <mesh_term>Thoracic Neoplasms</mesh_term>
      <mesh_term>Thoracic Diseases</mesh_term>
      <mesh_term>Aortic Dissection</mesh_term>
    </condition_browse>
    <!-- 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/NCT05988736
  org study id: 2022-7215-21602
  nct id: NCT05988736
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among
        patients undergoing thoracic surgery. The main questions it aims to answer are,
  
          1. Rate of successful intubation at first attempt and
  
          2. Time for intubation required with each device. Participants are required to sign the
             informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group
             B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath
             (VL) the differences in rate of successful intubation at first attempt and time for
             intubation required with each device.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Time required for correct placement of the Double Lumen Tube (DLT).
  time frame: During intervention time period
  description: Time will be measured in seconds during laryngoscopy while placement of Double Lumen Tube (DLT) until appearance of end tidal carbon dioxide on capnograph.
  measure: Successful Intubation at first attempt.
  time frame: immediately after Intervention.
  description: The number of times the laryngoscope will be inserted.
  arm group label: Group A
  arm group type: Experimental
  arm group label: Group B
  arm group type: Active Comparator
  intervention type: Device
  intervention name: MaCintosh Laryngoscope (DL)
  description: A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source.
  arm group label: Group A
  intervention type: Device
  intervention name: McGrath Laryngoscope (VL)
  description: A video Laryngoscope that has a high-resolution video camera, and a light source at the cone end of the blade allowing for direct and indirect viewing of the glottis
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: sadique Wadho, MBBS
  phone: +923322792932
  email: sadique.ali@aku.edu
  last name: Khalid Samad, MBBS, FCPS
  phone: +923343311603
  email: khalid.samad@aku.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Aga Khan University
  investigator full name: Sadique Ali
  investigator title: Principal Investigator
  mesh term: Empyema
  mesh term: Empyema, Pleural
  mesh term: Thoracic Neoplasms
  mesh term: Thoracic Diseases
  mesh term: Aortic Dissection