Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05130645
Other study ID # Mentum angle
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05535127 - Sequential Strategy vs Palpation vs Routine Ultrasound for Detection of Cricothyroid Membrane N/A
Not yet recruiting NCT05036460 - Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients N/A
Completed NCT05303948 - Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness N/A
Completed NCT06107751 - Ramped and Sniffing Position for Cesarean Section Intubation. N/A
Completed NCT04089540 - New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates N/A
Completed NCT05522049 - Videolaryngoscopic Intubation Using Macintosh vs.Hyperangulated Blades in Patients With Expected Difficult Intubation N/A
Completed NCT03046966 - Manikin To Patient Intubation: Does It Translate? N/A
Completed NCT06042829 - Impact of Covid-19 Aerosol Box On Intubation Success Rate N/A
Completed NCT06138119 - The Impact of Gender Stereotypes on Fiberoptic Intubation Performance N/A
Not yet recruiting NCT06115694 - Comparison of Video Laryngoscopy With Rigid Stylet vs Video Laryngoscopy With the TCI Articulating Introducer for Endotracheal Intubation in Simulated Difficult Airways N/A
Completed NCT05243758 - Who is Rapid And Success? The Comparison Of Video Fiberscope And Video Laryngoscope N/A
Completed NCT04833166 - Comparing Full vs. Partial Glottis View Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient N/A
Completed NCT03118596 - Fibre-optic Guided Tracheal Intubation Through SADs N/A
Recruiting NCT05680909 - Evaluation of SaCo Videolaryngeal Mask Airway in Morbidly Obese
Recruiting NCT05429112 - Flexible Tip Bougie vs Tube With Stylet for Intubation With a Videolaryngoscopy in ICU (VIDEOL-FLEXTIP) N/A
Completed NCT05833347 - Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients
Completed NCT05366582 - Neural Integrity Monitor Electromyogram (NIM-EMG) Endotracheal Tube Intubation With Video Laryngoscope N/A
Recruiting NCT06322719 - Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU N/A
Recruiting NCT06213389 - Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy N/A
Active, not recruiting NCT05884645 - Video Intelligence intubaTION (VITION)