Evaluation of Mandibular Mental Angle and Mandibular Profile Angle

Evaluation of Mandibular Mental Angle and Mandibular Profile Angle in Prediction of Difficult Intubation and Comparison With Other Tests

Airway management is extremely important for providing safe anesthesia. Endotracheal intubation, on the other hand, is the most important step in airway management, especially since it requires rapid and successful execution. Inadequate airway management; is associated with complications that require high-level care and cost, such as death, brain damage, increased need for intensive care, prolonged recovery period, and emergency tracheostomy. 15-25% of anesthesia-related deaths are associated with airway management. 17% of settled cases against anesthesiologists are composed of airway-related events (often difficult intubation, inadequate oxygenation/ventilation, and pulmonary aspiration).

An important point in ensuring airway patency is preoperative evaluation. Difficulties arising from anatomical features can be revealed by careful evaluation of mouth opening, the structure of tongue and palate, thyromental distance (TMM), sternomental distance (SMM), mobility of cervical vertebrae, jaw occlusion, and necessary precautions can be taken.

The most commonly used tests to determine the degree of difficulty of intubation are the modified Mallampati test, the thyromental distance, the upper lip bite test, the inter incisor space, and the sternomental distance. Recent studies are trying to confirm the sensitivity and specificity of existing tests. However, there is no test with 100% specificity and sensitivity in predicting difficult laryngoscopy and intubation.

Study Overview

• Status: Not yet recruiting
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Diagnostic test: Mental Angle

Detailed Description

In this prospective observational study, two new parameters "mandibular profile angle" and "mandibular mental angle" will be evaluated with the Cormack-Lehane Score during laryngoscopy as a predictor of difficult laryngoscopy. Modified Mallampati test, neck circumference, thyromental distance, sternomental distance, and many other tests have been used for predicting difficult intubation however, none of them are able to predict "difficult intubation" exactly. "mandibular profile angle" and "mandibular mental angle" may provide new horizons for predicting difficult intubation. These two measurements will be compared with the Cormack-Lehane score during laryngoscopy for sensitivity, specificity, and positive or negative predictive values. As well as the Cormack-Lehane Score, we will be comparing these angle measurements' predictive values with the other specified predictive tests such as Modified Mallampati test, neck circumference, thyromental distance, sternomental distance.

Having received informed consent, 1000 ASA I-III patients aged between 18-80, who will be operated under general anesthesia, will be included in this prospective observational study. The number of patients is determined according to the numbers in previous studies, but will be finalized as 90% power and 5% error as a result of the power analysis after the prior study.

Before the anesthesia induction the Modified Mallampati test, neck circumference, thyromental distance, sternomental distance will be measured as well as "mandibular profile angle" and "mandibular mental angle". "Mandibular profile angle" is defined as; The angle between the mentum of the mandibula and the lateral tips of the mandibula where the profiler ends. "Mandibular mental angle" is defined as; the angle between the mentum of the mandibula and the two ends of the mandibular arch.

After induction of anesthesia, the difficulty of laryngoscopy will be determined by Cormack-Lehane Score by a senior anesthesiologist.

Having received the measurements, tests for sensitivity and specificity, and negative/positive predictive values for difficult intubation will be processed.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Elif Şule Özdemir; Phone Number: +903125962524; Email: elifsule-91@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who will operated under general anesthesia by endotracheal intubation

Description

Inclusion Criteria:

• General Anesthesia
• ASA I,II,III

Exclusion Criteria:

• Patients with upper respiratory tract tumors
• history of surgery, burns and trauma to the upper respiratory tract
• congenital head-neck anomaly,
• giant goiter, and
• pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mandibular mental angle to predict the degree of difficulty in intubation	The angle between the mentum of the mandibula and the lateral tips of the mandibula where the profiler ends	5 min before intubation
Mandibular profile angle to predict the degree of difficulty in intubation	"Mandibular mental angle" is defined as; the angle between the mentum of the mandibula and the two ends of the mandibular arch.	5 min before intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cormack- Lehane grading system	It will be measured by an anesthesiologist during the use of direct laryngoscopy during intubation	Procedure (During the use of direct laryngoscopy for intubation)
Modified Mallampati test	The modified Mallampati test (MMT) is based on the visibility of the pharyngeal structures by opening the mouth as much as possible and sticking out the tongue while the patient is in a sitting position and the head is in a neutral position.	5 min before intubation
Neck circumference	Neck circumference is measured using a tape measure at the level of the thyroid cartilage with the head in a neutral position.	5 min before intubation
Thyromental distance	The thyromental distance is found by measuring the distance between the mental prominence of the mandible and the thyroid cartilage when the patient's head is in full extension.	5 min before intubation
Sternomental distance	Sternomental distance, when the patient's head is in full extension; It is determined by measuring the distance between the upper border of the manbrium sterni and the mental prominens of the mandible.	5 min before intubation
Upper lip bite test	The upper lip bite test is found by measuring the degree of biting the upper lip with the lower incisors.	5 min before intubation
Evaluation of mouth opening	It is found by measuring the distance between the upper and lower anterior incisors when the mouth is at its maximum opening.	5 min before intubation

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
• Investigators: Study Chair: Elif Şule Özdemir, Diskapi Yildirim Beyazit ERH

Study record dates

Study Major Dates

• Study Start (Anticipated): November 28, 2021
• Primary Completion (Anticipated): March 20, 2022
• Study Completion (Anticipated): April 20, 2022

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Mentum angle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If we can take a permission to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No