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

• ClinicalTrials.gov Identifier: NCT03826680
• Recruitment Status: Unknown
• First Posted: February 1, 2019
• Last Update Posted: July 25, 2019
• Sponsor: Istanbul University
• Information provided by (Responsible Party): Dr Cigdem Akyol Beyoğlu, Istanbul University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Cancer; Thyroid Nodule; Thyroid Adenoma	Procedure: Flexible fiberoptic laryngoscopy; Procedure: Direct laryngoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Screening
• 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
• Actual Study Start Date: March 19, 2019
• Estimated Primary Completion Date: June 2020
• Estimated Study Completion Date: July 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Flexible fiberoptic laryngoscopy; Patients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery	Procedure: Flexible fiberoptic laryngoscopy; Patients who will undergo thyroidectomy will be evaluated by awake flexible fiberoptic laryngoscopy and during surgery by direct laryngoscopy under general anesthesia
Active Comparator: Direct laryngoscopy; The same patients evaluated by flexible fiberoptic laryngoscopy will be evaluated by an anesthesiologist by direct laryngoscopy during surgery under general anesthesia	Procedure: Direct laryngoscopy; 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

Outcome Measures

Primary Outcome Measures :

1. Relation between MCL scores [ Time Frame: 24 hours ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Cigdem Akyol Beyoglu, MD; +905052278176; akyolbeyoglu@gmail.com

Contact: Emine D Gozen, MD; +905309424139; nazas39@hotmail.com

Locations

Turkey

Istanbul University- Cerrahpasa Department of Anesthesiology, general surgery, ENT surgery; Recruiting

Istanbul, Turkey, 34000

Contact: Cigdem Akyol Beyoglu, MD +905052278176 akyolbeyoglu@gmail.com

Contact: Emine D Gozen +905309424139 nazas39@hotmail.com

Sponsors and Collaborators

Istanbul University

Investigators

• Study Director: Guniz Koksal, Prof; Istanbul University-Cerrahpasa

More Information

• Responsible Party: Dr Cigdem Akyol Beyoğlu, Medical doctor, Istanbul University
• ClinicalTrials.gov Identifier: NCT03826680
• Other Study ID Numbers: 11/01/2019-6469
• First Posted: February 1, 2019
• Last Update Posted: July 25, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: all collected individual participant data (IPD)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Thyroid Neoplasms; Adenoma; Thyroid Nodule; Thyroid Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type