Evaluation of Mandibular Mental Angle and Mandibular Profile Angle
1 other identifier
observational
1,000
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Shorter than P25 for all trials
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
November 11, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Start
First participant enrolled
November 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2022
CompletedDecember 9, 2021
November 1, 2021
4 months
November 11, 2021
November 26, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Cormack- Lehane grading system
Procedure (During the use of direct laryngoscopy for intubation)
Modified Mallampati test
5 min before intubation
Neck circumference
5 min before intubation
Thyromental distance
5 min before intubation
Sternomental distance
5 min before intubation
- +2 more secondary outcomes
Interventions
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.
Eligibility Criteria
All patients who will operated under general anesthesia by endotracheal intubation
You may qualify if:
- General Anesthesia
- ASA I,II,III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY CHAIR
Elif Şule Özdemir
Diskapi Yildirim Beyazit ERH
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 11, 2021
First Posted
November 23, 2021
Study Start
November 28, 2021
Primary Completion
March 20, 2022
Study Completion
April 20, 2022
Last Updated
December 9, 2021
Record last verified: 2021-11