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

10 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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 .

Studietype

Ingrijpend

Inschrijving (Geschat)

134

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypte
        • Kasr Al-Ainy Hospital, Cairo University
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Determination of an optimal cutoff value for HMDR-ULBT to predict difficult laryngoscopy.
Tijdsspanne: 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.
Tijdsspanne: 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.

Medewerkers en onderzoekers

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Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 maart 2027

Studieregistratiedata

Eerst ingediend

7 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juni 2026

Eerst geplaatst (Werkelijk)

11 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Airway Ultrasound

Plan Individuele Deelnemersgegevens (IPD)

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NEE

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

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