<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/NCT03826680</url>
  </required_header>
  <id_info>
    <org_study_id>11/01/2019-6469</org_study_id>
    <nct_id>NCT03826680</nct_id>
  </id_info>
  <brief_title>Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia</brief_title>
  <official_title>The Relationship of Modified Cormack Lehane Scores Between Preoperative Awake Flexible Fiberoptic Laryngoscopy and Intraoperative Direct Laryngoscopy in Thyroidectomies, a Prospective, Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul 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>
      Nowadays, 5-step modified Cormack-Lehane scoring (MCL) system is frequently used in the&#xD;
      observation of laryngeal structures by direct laryngoscopy.&#xD;
&#xD;
      Upper airways with flexible fiberoptic laryngoscopy are routinely evaluated in patients who&#xD;
      are predicted to be difficult intubation, who have undergone head or neck surgery previously&#xD;
      and who require vocal cords to be evaluated preoperatively. During this examination patients&#xD;
      are awake; so the upper airway and the muscles in the base of the mouth have normal tonus and&#xD;
      airway reflexes are active. When general anesthesia is applied to the same patients during&#xD;
      direct laryngoscopy, the laryngeal view may not be as clear as awake flexible fiberoptic&#xD;
      laryngoscopy, since a tonus loss occurs in the muscles after general anesthesia.&#xD;
&#xD;
      The aim of the study is to investigate the relationship between preoperative awake flexible&#xD;
      fiberoptic laryngoscopy performed by ear- nose- throat (ENT) physicians in patients&#xD;
      undergoing total thyroidectomy, and the MCL score during direct laryngoscopy after general&#xD;
      anesthesia in the same patients. Thus, investigators would like to determine the reliability&#xD;
      of airway evaluation with preoperative awake flexible fiberoptic laryngoscopy in predicting&#xD;
      intubation conditions during tracheal intubation under general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In daily practice, the upper airway evaluation is performed by the ENT physician with&#xD;
      flexible fiberoptic laryngoscopy while the patients are awake one day before thyroidectomy.&#xD;
      This evaluation will be done by the same ENT physician (EDG). Each patient will be kept in&#xD;
      the neutral position and at the level of soft palate, the larynx will be observed by the&#xD;
      flexible fiberoptic laryngoscopy and the laryngeal view and MCL score of these patients will&#xD;
      be recorded.&#xD;
&#xD;
      The same patients will be taken to the preoperative care unit on the morning of operation and&#xD;
      20 G intravenous cannulation will be performed on the left hand. Patients' neck circumference&#xD;
      and Mallampati score and presence of obstructive sleep apnea syndrome will be recorded.&#xD;
      Patients will be taken to the operation theatre and standard monitoring will be performed&#xD;
      consisting of electrocardiography (ECG), non-invasive blood pressure (BP) and peripheral O2&#xD;
      saturation. After induction of general anesthesia, the same anesthesiologist (CAB) will&#xD;
      perform direct laryngoscopy by using Macintosh laryngoscope the MCL score will be recorded.&#xD;
      The anesthesiologist will not know the MCL score that was previously evaluated by ENT&#xD;
      physician during awake fiberoptic flexible laryngoscopy. Female and male patients will be&#xD;
      intubated orotracheally with 7.5-8 internal diameter endotracheal tube, respectively. It will&#xD;
      be recorded if the backward, upward, right, lateral pressure Maneuver (BURP) is applied&#xD;
      during intubation. The maintenance of general anesthesia will be provided with 2% Sevoflurane&#xD;
      in a 40% oxygen-air mixture.&#xD;
&#xD;
      After thyroidectomy is over patients will be extubated. The primary endpoint of the study was&#xD;
      to evaluate the relationship between the MCL score, which was evaluated preoperatively, and&#xD;
      the MCL score during direct laryngoscopy during intraoperative general anesthesia in awake&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 19, 2019</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relation between MCL scores</measure>
    <time_frame>24 hours</time_frame>
    <description>The primary outcome measure of the study is a 5 graded modified Cormack Lehane scores obtained from patients before and during thyroidectomy. The first measurement will be done one day before surgery, while patient is awake by flexible fiberoptic laryngoscopy. The second measurement will be done during surgery, after induction of general anesthesia by direct laryngoscopy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Thyroid Cancer</condition>
  <condition>Thyroid Nodule</condition>
  <condition>Thyroid Adenoma</condition>
  <arm_group>
    <arm_group_label>Flexible fiberoptic laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The same patients evaluated by flexible fiberoptic laryngoscopy will be evaluated by an anesthesiologist by direct laryngoscopy during surgery under general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Flexible fiberoptic laryngoscopy</intervention_name>
    <description>Patients who will undergo thyroidectomy will be evaluated by awake flexible fiberoptic laryngoscopy and during surgery by direct laryngoscopy under general anesthesia</description>
    <arm_group_label>Flexible fiberoptic laryngoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct laryngoscopy</intervention_name>
    <description>Patients who will undergo thyroidectomy evaluated before by ENT physician, will be evaluated by anesthesiologist in means of MCL score by direct laryngoscopy during surgery under general anesthesia</description>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who will undergo total or partial thyroidectomy&#xD;
&#xD;
          -  American Society of Anesthesiologists class of I to III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to attend to study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guniz Koksal, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cigdem Akyol Beyoglu, MD</last_name>
    <phone>+905052278176</phone>
    <email>akyolbeyoglu@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emine D Gozen, MD</last_name>
    <phone>+905309424139</phone>
    <email>nazas39@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istanbul University- Cerrahpasa Department of Anesthesiology, general surgery, ENT surgery</name>
      <address>
        <city>Istanbul</city>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cigdem Akyol Beyoglu, MD</last_name>
      <phone>+905052278176</phone>
      <email>akyolbeyoglu@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Emine D Gozen</last_name>
      <phone>+905309424139</phone>
      <email>nazas39@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 29, 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>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Dr Cigdem Akyol Beyoğlu</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>all collected individual participant data (IPD)</ipd_description>
  </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/NCT03826680
org study id: 11/01/2019-6469
nct id: NCT03826680
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nowadays, 5-step modified Cormack-Lehane scoring (MCL) system is frequently used in the
      observation of laryngeal structures by direct laryngoscopy.

      Upper airways with flexible fiberoptic laryngoscopy are routinely evaluated in patients who
      are predicted to be difficult intubation, who have undergone head or neck surgery previously
      and who require vocal cords to be evaluated preoperatively. During this examination patients
      are awake; so the upper airway and the muscles in the base of the mouth have normal tonus and
      airway reflexes are active. When general anesthesia is applied to the same patients during
      direct laryngoscopy, the laryngeal view may not be as clear as awake flexible fiberoptic
      laryngoscopy, since a tonus loss occurs in the muscles after general anesthesia.

      The aim of the study is to investigate the relationship between preoperative awake flexible
      fiberoptic laryngoscopy performed by ear- nose- throat (ENT) physicians in patients
      undergoing total thyroidectomy, and the MCL score during direct laryngoscopy after general
      anesthesia in the same patients. Thus, investigators would like to determine the reliability
      of airway evaluation with preoperative awake flexible fiberoptic laryngoscopy in predicting
      intubation conditions during tracheal intubation under general anesthesia.
In daily practice, the upper airway evaluation is performed by the ENT physician with
      flexible fiberoptic laryngoscopy while the patients are awake one day before thyroidectomy.
      This evaluation will be done by the same ENT physician (EDG). Each patient will be kept in
      the neutral position and at the level of soft palate, the larynx will be observed by the
      flexible fiberoptic laryngoscopy and the laryngeal view and MCL score of these patients will
      be recorded.

      The same patients will be taken to the preoperative care unit on the morning of operation and
      20 G intravenous cannulation will be performed on the left hand. Patients' neck circumference
      and Mallampati score and presence of obstructive sleep apnea syndrome will be recorded.
      Patients will be taken to the operation theatre and standard monitoring will be performed
      consisting of electrocardiography (ECG), non-invasive blood pressure (BP) and peripheral O2
      saturation. After induction of general anesthesia, the same anesthesiologist (CAB) will
      perform direct laryngoscopy by using Macintosh laryngoscope the MCL score will be recorded.
      The anesthesiologist will not know the MCL score that was previously evaluated by ENT
      physician during awake fiberoptic flexible laryngoscopy. Female and male patients will be
      intubated orotracheally with 7.5-8 internal diameter endotracheal tube, respectively. It will
      be recorded if the backward, upward, right, lateral pressure Maneuver (BURP) is applied
      during intubation. The maintenance of general anesthesia will be provided with 2% Sevoflurane
      in a 40% oxygen-air mixture.

      After thyroidectomy is over patients will be extubated. The primary endpoint of the study was
      to evaluate the relationship between the MCL score, which was evaluated preoperatively, and
      the MCL score during direct laryngoscopy during intraoperative general anesthesia in awake
      patients.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Screening
masking: Triple (Participant, Care Provider, Investigator)
measure: Relation between MCL scores
time frame: 24 hours
description: The primary outcome measure of the study is a 5 graded modified Cormack Lehane scores obtained from patients before and during thyroidectomy. The first measurement will be done one day before surgery, while patient is awake by flexible fiberoptic laryngoscopy. The second measurement will be done during surgery, after induction of general anesthesia by direct laryngoscopy
arm group label: Flexible fiberoptic laryngoscopy
arm group type: Active Comparator
description: Patients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery
arm group label: Direct laryngoscopy
arm group type: Active Comparator
description: The same patients evaluated by flexible fiberoptic laryngoscopy will be evaluated by an anesthesiologist by direct laryngoscopy during surgery under general anesthesia
intervention type: Procedure
intervention name: Flexible fiberoptic laryngoscopy
description: Patients who will undergo thyroidectomy will be evaluated by awake flexible fiberoptic laryngoscopy and during surgery by direct laryngoscopy under general anesthesia
arm group label: Flexible fiberoptic laryngoscopy
intervention type: Procedure
intervention name: Direct laryngoscopy
description: Patients who will undergo thyroidectomy evaluated before by ENT physician, will be evaluated by anesthesiologist in means of MCL score by direct laryngoscopy during surgery under general anesthesia
arm group label: Direct laryngoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guniz Koksal, Prof
role: Study Director
affiliation: Istanbul University - Cerrahpasa (IUC)
last name: Cigdem Akyol Beyoglu, MD
phone: +905052278176
email: akyolbeyoglu@gmail.com
last name: Emine D Gozen, MD
phone: +905309424139
email: nazas39@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Dr Cigdem Akyol Beyoğlu
investigator title: Medical doctor
mesh term: Thyroid Neoplasms
mesh term: Adenoma
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases
sharing ipd: No
ipd description: all collected individual participant data (IPD)