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NOT YET RECRUITING
NCT07315256
NA

Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

This study will evaluate how well an ultrasound measurement of the distance from the skin to the epiglottis, when combined with the modified Mallampati score, can predict difficult laryngoscopy in adult patients undergoing elective surgery under general anesthesia. Adult patients scheduled for surgery requiring tracheal intubation will be randomly assigned to two assessment strategies before anesthesia: one group will have the usual bedside airway assessment with modified Mallampati alone, and the other group will have modified Mallampati plus a quick, painless ultrasound scan of the front of the neck to measure the skin-to-epiglottis distance. During intubation, the anesthesiologist, who is blinded to the preoperative assessments, will grade the laryngoscopic view using the Cormack-Lehane classification, and the investigators will compare how accurately each assessment approach predicts difficult laryngoscopy (grade 3-4). The study does not change how anesthesia or airway management is performed; ultrasound and clinical assessments are added solely for measurement and data collection, with minimal risk to participants and potential future benefits in improving airway risk stratification and patient safety.

Official title: Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia: A Prospective, Randomized Double Blinded Controlled Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-01

Completion Date

2027-02

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Ultrasound-Guided Skin-to-Epiglottis Distance Measurement

Point-of-care airway ultrasound of the anterior neck using a high-frequency linear probe (10-13 MHz) placed transversely at the thyrohyoid membrane to measure the vertical skin-to-epiglottis distance in millimeters. The scan is performed preoperatively in supine neutral position, is non-invasive and painless, and does not alter anesthetic or airway management, which follow standard clinical practice. This measurement is combined with the modified Mallampati score in the experimental arm to predict difficult laryngoscopy (Cormack-Lehane grade 3-4).

DIAGNOSTIC_TEST

Clinical Airway Assessment With Modified Mallampati Score

Standard preoperative bedside airway assessment using the modified Mallampati score without airway ultrasound; performed in the sitting position with mouth opening and maximal tongue protrusion, used routinely to anticipate difficulty of laryngoscopy.