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

10 de junio de 2026 actualizado por: Makarious Morris Aboelkheir Shenouda, Cairo University

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

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.

Descripción general del estudio

Descripción detallada

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 .

Tipo de estudio

Intervencionista

Inscripción (Estimado)

134

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Yasmin Khaled Ahmed, MD
  • Número de teléfono: +201095015566
  • Correo electrónico: dr_ykh@hotmail.com

Ubicaciones de estudio

    • Cairo Governorate
      • Cairo, Cairo Governorate, Egipto
        • Kasr Al-Ainy Hospital, Cairo University
        • Contacto:
        • Contacto:
          • Yasmin Khalid Ahmed, MD
          • Número de teléfono: +201095015566
          • Correo electrónico: dr_ykh@hotmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: HMD measured by US in neutral head position , maximum head extension and during upper lip bite 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).
Hyomental distance will be measured using ultrasound in three positions: neutral head position, maximum head extension, and during the upper lip bite test (ULBT).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prediction of difficult laryngoscopic view, defined as Cormack-Lehane Grade 3 or 4 on the first laryngoscopy attempt without external laryngeal manipulation.
Periodo de tiempo: 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.

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Determination of an optimal cutoff value for HMDR-ULBT to predict difficult laryngoscopy.
Periodo de tiempo: 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.
From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia on the day of surgery
Comparison of HMDR-ULBT with standard HMDR in predicting difficult laryngoscopy.
Periodo de tiempo: 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.
From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

7 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Airway Ultrasound

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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