Evaluation of Mandibular Mental Angle and Mandibular Profile Angle

Intubation; Difficult or Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05130645
• Other study ID #: Mentum angle
• Status: Not yet recruiting
• Start date: November 28, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: November 2021
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Elif Sule Özdemir
• Phone: +903125962524
• Email: elifsule-91[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: April 20, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Diagnostic Test:
• Mental Angle
In order to standardize and measure the mental angle, the projection of the mental will be accepted as the midline, the jaw structure will be transferred to the paper using the profile contour meter, and the angle between the angulus mandible and the mental will be measured and recorded with a digital protractor.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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