Intubation; Difficult or FailedNCT05130645
Evaluation of Mandibular Mental Angle and Mandibular Profile Angle
An observational study of Intubation; Difficult or Failed, run by Diskapi Yildirim Beyazit Education and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Mental Angle
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2021to 20 Apr 2022
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who will operated under general anesthesia by endotracheal intubation
Who may be able to join
- General Anesthesia
- ASA I,II,III
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Mental Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental AngleDiagnostic test
Also called Profiler Type 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 5 min before intubation
Secondary outcomes (7)
Cormack- Lehane grading system
It will be measured by an anesthesiologist during the use of direct laryngoscopy during intubation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 min before intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start28 Nov 2021 (estimated)
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Elif Şule Özdemir, Study chair, Diskapi Yildirim Beyazit ERH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130645
- Sponsor's protocol ID
- Mentum angle
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If we can take a permission to share
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mandibular Mental Angle and Mandibular Profile Angle in Prediction of Difficult Intubation and Comparison With Other Tests
- ClinicalTrials.gov ID
- NCT05130645
- Acronym / sponsor ID
- Mentum angle
- Conditions
- Intubation; Difficult or Failed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 28 Nov 2021 (estimated)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will operated under general anesthesia by endotracheal intubation
Key inclusion criteria (2 listed)
- General Anesthesia
- ASA I,II,III
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental AngleAlso: Profiler Type Mental AngleIn 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. | Diagnostic test | – |
Primary outcome
Mandibular mental angle to predict the degree of difficulty in intubation
Time frame: 5 min before intubation
The angle between the mentum of the mandibula and the lateral tips of the mandibula where the profiler ends
Mandibular profile angle to predict the degree of difficulty in intubation
Time frame: 5 min before intubation
"Mandibular mental angle" is defined as; the angle between the mentum of the mandibula and the two ends of the mandibular arch.
7 secondary outcomes
Cormack- Lehane grading system
Time frame: Procedure (During the use of direct laryngoscopy for intubation)
Modified Mallampati test
Time frame: 5 min before intubation
Neck circumference
Time frame: 5 min before intubation
Thyromental distance
Time frame: 5 min before intubation
Sternomental distance
Time frame: 5 min before intubation
Upper lip bite test
Time frame: 5 min before intubation
Evaluation of mouth opening
Time frame: 5 min before intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: Undecided. If we can take a permission to share
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PrediSuisse: Automatized Assessment of Difficult Airway
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Şule Özdemir study chair
Diskapi Yildirim Beyazit ERH
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult or Failed, run by Diskapi Yildirim Beyazit Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Şule Özdemir (+903125962524, elifsule-91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular mental angle to predict the degree of difficulty in intubation (time frame: 5 min before intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.