Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia
Primary Purpose
Thyroid Cancer, Thyroid Nodule, Thyroid Adenoma
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Flexible fiberoptic laryngoscopy
Direct laryngoscopy
Sponsored by
About this trial
This is an interventional screening trial for Thyroid Cancer
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
Sites / Locations
- Istanbul University- Cerrahpasa Department of Anesthesiology, general surgery, ENT surgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Flexible fiberoptic laryngoscopy
Direct laryngoscopy
Arm Description
Patients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery
The same patients evaluated by flexible fiberoptic laryngoscopy will be evaluated by an anesthesiologist by direct laryngoscopy during surgery under general anesthesia
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03826680
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Thyroid Nodule, Thyroid Adenoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flexible fiberoptic laryngoscopy
Arm Type
Active Comparator
Arm Description
Patients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery
Arm Title
Direct laryngoscopy
Arm Type
Active Comparator
Arm 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(s)
Flexible fiberoptic laryngoscopy
Intervention Description
Patients who will undergo thyroidectomy will be evaluated by awake flexible fiberoptic laryngoscopy and during surgery by direct laryngoscopy under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Direct laryngoscopy
Intervention 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
Primary Outcome Measure Information:
Title
Relation between MCL scores
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
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cigdem Akyol Beyoglu, MD
Phone
+905052278176
Email
akyolbeyoglu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emine D Gozen, MD
Phone
+905309424139
Email
nazas39@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guniz Koksal, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University- Cerrahpasa Department of Anesthesiology, general surgery, ENT surgery
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cigdem Akyol Beyoglu, MD
Phone
+905052278176
Email
akyolbeyoglu@gmail.com
First Name & Middle Initial & Last Name & Degree
Emine D Gozen
Phone
+905309424139
Email
nazas39@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
all collected individual participant data (IPD)
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Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia
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