An observational study in Ultrasound, Difficult Laryngoscopy and Prediction, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Tanta University · Observational
This study aims to evaluate the ultrasonographic parameters (distance from skin to epiglottis (DSE) and distance from skin to vocal cords (DSVC)) as preoperative predictors of difficult laryngoscopy in non-suspected difficult airway patients undergoing elective surgery.
Airway management is an integral part of general anesthesia. It simply aims to secure the patient's airway and achieve adequate ventilation and oxygenation for the patient undergoing surgery under general anesthesia. Unsuccessful airway management due to the unexpected difficulty in laryngoscopy is a life-threatening situation and may lead to morbidity and mortality.
Many conventional clinical tests are used in preoperative airway assessment such as modified Mallampati classification, Thyro-mental distance, inter-incisor distance, cervical mobility, and neck circumference, which are used to predict difficulty in the airway, but they have limited value and low sensitivity and specificity. Difficult laryngoscopy cannot be always predicted based on the preoperative assessment by conventional clinical tests. Some patients are thought to have an easy airway by clinical tests, but they show an unexpected difficulty in the laryngoscopy.
The laryngeal view of the patient can be assessed and graded during direct laryngoscopy using the Cormack and Lehane grading scale and its modification that describes the laryngoscopy as easy or difficult.
Ultrasonography is a valuable promising tool for preoperative airway evaluation through identifying important sonoanatomy of the upper airway such as epiglottis, thyroid cartilage, and vocal cords.
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
This retrospective observational study will be carried out on 85 patients at Tanta University Hospital in the anesthesia department over a period of one year from May 2022 to May 2023, which may be extended after approval from the institutional ethical committee of the faculty of medicine at Tanta University.
Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Exclusion Criteria:
Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Procedure: Ultrasound
Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Procedure: Ultrasound
Ultrasonographic parameters: in the parasagittal plane (1cm from midline) with the patient lying supine, without a pillow, head, and neck in the neutral position, looking straight ahead with mouth closed and the tongue on the floor of the mouth without any movement.
Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale
Correlation between the ultrasonographic parameters (distance from skin to epiglottis ( DSE) and distance from skin to vocal cords (DSVC)) and the modified Cormack and Lehane grading scale of laryngoscopy as easy or difficult
Time frame: 10 minutes during intubation.
Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Measurement of Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy. Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Time frame: 10 minutes during intubation.
Sensitivity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.
Measurement of Sensitivity of ultrasonographic distance from skin to epiglottis to predict easy laryngoscopy. Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Time frame: 10 minutes during intubation.
Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Measurement of Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy. Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Time frame: 10 minutes during intubation.
Specificity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.
Measurement of Specificity of ultrasonographic distance from skin to epiglottis to predict easy laryngoscopy. Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Time frame: 10 minutes during intubation.
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tanta University