Ultrasonographic Parameters in Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients

Completed

• Conditions: Prediction; Ultrasound; Difficult Laryngoscopy
• Interventions: Procedure: Ultrasound

• Registration Number: NCT06052189
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-25
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Aged 18 - 65 years.
• Both sexes.
• Patients who aren't suspected to have a difficult airway after preoperative airway assessment by conventional clinical tests such as modified Mallampati classification (MMC), thyromental distance (TMD), inter-incisor distance (IID), cervical mobility (CM), And neck circumference (NC).
• American society of anesthesia (ASA) I, II, and III physical status.
• Scheduled for elective surgery under general anaethesia.

Exclusion Criteria

• Patients with maxillofacial injury and airway trauma.
• Patients with a history of previous difficult intubation.
• Patients with anatomical abnormalities.
• Neck scarring, swelling, or burn.
• Pregnancy.
• Obesity.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Difficult laryngoscopy	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.
Easy laryngoscopy	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.

Primary Outcome Measures

Name	Time	Method
Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale	10 minutes during intubation.	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

Secondary Outcome Measures

Name	Time	Method
Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.	10 minutes during intubation.	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.
Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.	10 minutes during intubation.	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.
Sensitivity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.	10 minutes during intubation.	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.
Specificity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.	10 minutes during intubation.	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt