Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia

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Brief Title

Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia

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

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Relation between MCL scores


Condition

Thyroid Cancer

Intervention

Flexible fiberoptic laryngoscopy

Study Arms / Comparison Groups

 Flexible fiberoptic laryngoscopy
Description:  Patients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

March 19, 2019

Completion Date

July 2020

Primary Completion Date

June 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who will undergo total or partial thyroidectomy

          -  American Society of Anesthesiologists class of I to III

        Exclusion Criteria:

          -  Patients refusing to attend to study
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Guniz Koksal, Prof, +905052278176, [email protected]

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT03826680

Organization ID

11/01/2019-6469


Responsible Party

Principal Investigator

Study Sponsor

Istanbul University


Study Sponsor

Guniz Koksal, Prof, Study Director, Istanbul University-Cerrahpasa


Verification Date

July 2019