Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia
The Relationship of Modified Cormack Lehane Scores Between Preoperative Awake Flexible Fiberoptic Laryngoscopy and Intraoperative Direct Laryngoscopy in Thyroidectomies, a Prospective, Clinical Study
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJuly 25, 2019
July 1, 2019
1.2 years
January 29, 2019
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Relation between MCL scores
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
24 hours
Study Arms (2)
Flexible fiberoptic laryngoscopy
ACTIVE COMPARATORPatients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery
Direct laryngoscopy
ACTIVE COMPARATORThe same patients evaluated by flexible fiberoptic laryngoscopy will be evaluated by an anesthesiologist by direct laryngoscopy during surgery under general anesthesia
Interventions
Patients who will undergo thyroidectomy will be evaluated by awake flexible fiberoptic laryngoscopy and during surgery by direct laryngoscopy under general anesthesia
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
Eligibility Criteria
You may qualify if:
- Patients who will undergo total or partial thyroidectomy
- American Society of Anesthesiologists class of I to III
You may not qualify if:
- Patients refusing to attend to study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University- Cerrahpasa Department of Anesthesiology, general surgery, ENT surgery
Istanbul, 34000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guniz Koksal, Prof
Istanbul University - Cerrahpasa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
January 29, 2019
First Posted
February 1, 2019
Study Start
March 19, 2019
Primary Completion
June 1, 2020
Study Completion
July 1, 2020
Last Updated
July 25, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share
all collected individual participant data (IPD)