NCT07642206

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 7, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

airway ultrasoundupper lip bite test

Outcome Measures

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.

    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.

Secondary Outcomes (2)

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

    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.

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

Study Arms (1)

HMD measured by US in neutral head position , maximum head extension and during upper lip bite test

OTHER

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

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

Interventions

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

HMD measured by US in neutral head position , maximum head extension and during upper lip bite test

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al-Ainy Hospital, Cairo University

Cairo, Cairo Governorate, Egypt

Location

Related Publications (4)

  • Bhanushali A, Date A. Evaluation of upper lip bite test and thyromental height test for prediction of difficult laryngoscopy: A prospective observational study. Airway. 2021;4(3):621-42.

    BACKGROUND
  • Hrithma D, K R, Mahadevaiah DT, K N V. A Cross-Sectional Study on Hyomental Distance Ratio (HMDR) as a New Predictor of Difficult Laryngoscopy in ICU Patients. Cureus. 2022 May 28;14(5):e25435. doi: 10.7759/cureus.25435. eCollection 2022 May.

    PMID: 35774688BACKGROUND
  • Liaskou C, Vouzounerakis E, Trikoupi A, Staikou C. [Evaluation of bedside tests and proposal of a model for predicting difficult laryngoscopy: an observational prospective study]. Braz J Anesthesiol. 2020 Mar-Apr;70(2):125-133. doi: 10.1016/j.bjan.2020.02.007. Epub 2020 May 13.

    PMID: 32482358BACKGROUND
  • Liu Y, He Y, Wang X, Li J, Zhang Z, Zhuang X, et al. Advances in airway management in recent 10 years from 2013 to 2023. Anesthesiol Perioper Sci. 2023;1(4):27-30.

    BACKGROUND

Central Study Contacts

Makarious Morris Aboelkheir, MSc

CONTACT

Yasmin Khaled Ahmed, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Hyomental distance will be measured using ultrasound in three different positions, neutral head position , maximum head extension and during performing upper lip bite test .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 11, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations