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NCT Number: NCT07642206

Combined Ultrasound and Upper Lip Bite Test Assessment of Difficult Laryngoscopy in Obese Patients

The aim of this observational study is to evaluate the accuracy of the HMDR combined with the ULBT as a predictor of difficult laryngoscopy in obese patients undergoing elective surgery under general anesthesia, regarding:

* Correlation of HMDR-ULBT values with Cormack-Lehane grades during laryngoscopy. * Comparison of HMDR-ULBT with standard HMDR in predicting difficult laryngoscopy.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Airway management is a cornerstone of safe anesthesia practice. Difficult laryngoscopy and intubation remain a critical challenge for anesthesiologists. The ability to predict difficult airway situations preoperatively remains crucial, particularly in high-risk populations such as obese patients. These patients have significantly higher rates of difficult mask ventilation and tracheal intubation.

Numerous bedside screening tests have been established to predict difficult laryngoscopy, including the Mallampati classification, thyromental distance, the upper lip bite test (ULBT), and hyomental distance (HMD) measurements. However, none of these tests alone possesses sufficient sensitivity or specificity, and their predictive performance in obese individuals remains variable .

The Hyomental Distance Ratio (HMDR), defined as the ratio of the hyomental distance in maximal head extension to that in the neutral position , is a dynamic parameter reflecting upper airway compliance and anatomical displacement. An HMDR value <1.2 has been associated with increased risk of difficult laryngoscopy in several studies . Traditionally, the HMDR is measured either manually with a ruler or more objectively using ultrasound.

The Upper Lip Bite Test (ULBT) is a simple, validated bedside test assessing mandibular protrusion and temporomandibular joint mobility, two key factors influencing the success of glottic visualization . The ULBT is performed in a conscious state, making it a practical tool in airway assessment.

Given that the ULBT involves active mandibular protrusion, it may mimic the anterior displacement of airway structures achieved during head extension or jaw thrust. Therefore, measuring the hyomental distance while the patient performs the ULBT could serve as a novel dynamic modification of the traditional HMDR-potentially offering a more functional and patient-cooperative measure.

Recent studies have validated the HMDR (extension/neutral) as a useful predictor of difficult laryngoscopy by ultrasound, due to its capacity to evaluate the anterior neck space and upper airway alignment . However, these studies primarily assess neck extension without incorporating mandibular movement, despite its key role in airway visualization. To date, no published studies have evaluated the hyomental distance combined with the ULBT using ultrasound or compared it with the traditional HMDR, leaving an interesting gap in the literature.

Combining the anatomical advantages of anterior neck space assessment with functional jaw mobility via the HMDR combined with the ULBT may yield a more comprehensive and accurate predictor of difficult airway, especially in obese or anatomically challenging patients. This novel approach may detect subtle impairments in upper airway dynamics not captured by the static HMDR alone. To our knowledge, this application has not yet been explored in existing literature.

This study, therefore, aims to evaluate the accuracy of the HMDR combined with the ULBT as a predictor of difficult laryngoscopy in obese patients undergoing elective surgery under general anesthesia, using difficult laryngoscopy-defined as Cormack-Lehane grade 3 or 4-as the primary outcome .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult obese patients aged 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status II- III.
  • Body Mass Index (BMI) ≥ 30 kg/m² (classified as obese).
  • Scheduled for elective surgical procedures requiring general anesthesia with endotracheal intubation.
  • Ability to understand and provide informed written consent.
  • Cooperative and able to perform the ULBT on command.
  • Normal dentition (presence of upper and lower incisors to perform ULBT accurately).

Exclusion criteria

  • History of maxillofacial trauma, surgery, or congenital facial anomalies affecting mandibular movement or neck anatomy.
  • Known or suspected difficult airway requiring awake intubation.
  • Patients with limited neck mobility (e.g., cervical spine disease or immobilization).
  • Temporomandibular joint disorders or restricted mandibular mobility.
  • Pregnancy.

Treatment and study plan

Hyomental distance measured using ultrasound in neutral head position, maximum head extension and during upper lip bite test

Diagnostic Test

Hyomental distance will be measured using ultrasound in three positions: neutral head position, maximum head extension, and during the upper lip bite test (ULBT).

Primary outcomes

  1. Prediction of difficult laryngoscopic view, defined as Cormack-Lehane Grade 3 or 4 on the first laryngoscopy attempt without external laryngeal manipulation.

    Time frame: Day of surgery from preoperative assessment to first laryngoscopy attempt after induction of general anethesia and after three minutes of mask ventilation.

    Difficult laryngoscopic view is defined as Cormack-Lehane Grade III or IV during the first laryngoscopy attempt without external laryngeal manipulation

    Cormack-Lehane classification for laryngoscopic view :

    grade 1: most of the vocal cords is seen; grade 2: only the posterior part of the vocal cords or the arytenoid cartilages are seen; grade 3: only epiglottis is seen; grade 4: epiglottis is not seen.

Secondary outcomes

  1. Determination of an optimal cutoff value for HMDR-ULBT to predict difficult laryngoscopy.

    Time frame: From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia on the day of surgery

    Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cutoff value of the hyomental distance ratio measured during the upper lip bite test (HMDR-ULBT) for predicting difficult laryngoscopic view, defined as Cormack-Lehane Grade III or IV on the first laryngoscopy attempt without external laryngeal manipulation. The area under the ROC curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value corresponding to the optimal cutoff value will be calculated.

  2. Comparison of HMDR-ULBT with standard HMDR in predicting difficult laryngoscopy.

    Time frame: From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia.

    The predictive performance of the hyomental distance ratio measured during the upper lip bite test (HMDR-ULBT) will be compared with that of the standard hyomental distance ratio (HMDR) for predicting difficult laryngoscopic view, defined as Cormack-Lehane Grade III or IV during the first laryngoscopy attempt without external laryngeal manipulation. Diagnostic accuracy parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve, will be compared between the two methods.

Study contacts

Contact information is provided by the study sponsor or research team.

Makarious Morris Aboelkheir, MSc

CONTACT

[email protected]

+201225246321

Yasmin Khaled Ahmed, MD

CONTACT

[email protected]

+201095015566

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Ultrasound-Measured Hyomental Distance Ratio Combined With the Upper Lip Bite Test as a Predictor of Difficult Laryngoscopy in Obese Patients: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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