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Not yet recruitingNCT07346768Updated Sep 10, 2026

Evaluation of Anterior Neck Ultrasound in Predicting Difficult Airway in Obese Patients

An observational study in Ultrasonography, Airway Management and Intubation, Intratracheal, sponsored by Gaziantep City Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Gaziantep City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Obese patients are at increased risk of difficult airway management due to anatomical changes in the anterior neck soft tissues. Accurate preoperative prediction of difficult airway remains challenging using conventional clinical airway assessment tests alone.

This prospective observational study aims to evaluate the role of ultrasound assessment of anterior neck soft tissue thickness in predicting difficult airway risk in overweight and obese adult patients undergoing elective surgery under general anesthesia. Ultrasound-based anterior neck measurements will be compared with standard clinical airway assessment parameters to determine their diagnostic accuracy for difficult laryngoscopy and intubation.

The results of this study may contribute to improved preoperative airway risk stratification and safer airway management in obese patients.

Read the detailed description

Difficult airway management remains a major concern in anesthetic practice and is associated with increased morbidity, particularly in obese patients. Excess anterior neck soft tissue and altered upper airway anatomy contribute to challenges in mask ventilation, laryngoscopy, and tracheal intubation. Conventional clinical airway assessment tests have limited predictive accuracy in this population, highlighting the need for additional objective assessment tools.

This prospective observational study is designed to evaluate the predictive value of ultrasound-based assessment of anterior neck soft tissue thickness for difficult airway risk in overweight and obese adult patients undergoing elective surgery under general anesthesia. The study will be conducted at a single tertiary care center after ethics committee approval, and written informed consent will be obtained from all participants.

Eligible patients aged 18-70 years with a body mass index (BMI) greater than 25 kg/m² and classified as ASA physical status I-III will be included. Emergency surgeries, pregnant patients, individuals with known difficult airway history, maxillofacial anomalies, neck masses, or a BMI greater than 60 kg/m² will be excluded.

Preoperative airway assessment will include conventional clinical parameters such as modified Mallampati score, mouth opening, interincisor distance, thyromental distance, sternomental distance, neck circumference, neck mobility, upper lip bite test, and snoring history. In addition, anterior neck ultrasound measurements will be performed preoperatively in the supine position using a high-frequency linear probe by trained anesthesiologists following a standardized protocol. Ultrasound parameters will include tongue dimensions, hyomental distance, skin-to-hyoid distance, skin-to-epiglottis distance, skin-to-vocal cords distance, skin-to-thyroid isthmus distance, skin-to-suprasternal notch distance, and the pre-epiglottic space to epiglottis-vocal cords distance ratio (PE/E-VC). Anterior neck ultrasound measurements will performed preoperatively by trained anesthesiologists using a standardized protocol.

A single prospective cohort of overweight/obese surgical patients will undergo preoperative ultrasound and clinical airway assessments, and outcomes during induction will be recorded. After induction of general anesthesia, laryngoscopic view will be assessed using the Cormack-Lehane classification. Difficult laryngoscopy will be defined as Cormack-Lehane grade III or IV. Intubation difficulty will be evaluated using the Intubation Difficulty Scale (IDS), and mask ventilation difficulty will be assessed using the Han scale. Intraoperative airway management data, including number of intubation attempts, need for adjuncts, alternative techniques, and airway-related complications, will be recorded.

Statistical analysis will focus on determining the diagnostic accuracy of ultrasound and clinical airway parameters. Receiver operating characteristic (ROC) curve analysis will be used to calculate the area under the curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value for each parameter and selected combinations. The findings aim to clarify the role of anterior neck ultrasound as a complementary tool for preoperative airway risk stratification in obese patients.

02

Conditions studied

  • Ultrasonography
  • Airway Management
  • Intubation, Intratracheal
  • Obesity and Overweight

Keywords

  • Obesity
  • difficult airway
  • anterior neck ultrasound
  • ultrasonography
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Overweight and obese adult patients undergoing elective surgery under general anesthesia

Inclusion criteria

  • Age 18-70 years
  • ASA physical status I-III

    * BMI >25 kg/m²

  • Scheduled for elective surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Emergency surgery
  • Pregnancy
  • Maxillofacial anomalies or neck masses
  • Rapid sequence induction
  • Previous history of difficult intubation
  • BMI >60 kg/m²
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • Overweight and Obese Surgical Patients

    Adult overweight and obese patients undergoing elective surgery under general anesthesia who will receive standard care airway management.

    Other: None (Observational study)

Interventions

  • OtherNone (Observational study)

    one group, there is no intervention. All measurements and observations will be performed during routine clinical care only

05

What researchers measure

Primary outcomes

  1. Cormack-Lehane grade III-IV

    Occurrence of difficult airway during anesthesia induction, defined by difficult laryngoscopy

    Time frame: During anesthesia induction

Secondary outcomes

  1. Ultrasound-derived anterior neck soft tissue measurements

    diagnostic accuracy for predicting difficult airway (ROC-AUC)

    Time frame: During anesthesia induction

  2. Intubation Difficulty Scale (IDS) score

    Difficult intubation: IDS score \> 5

    Time frame: during tracheal intubation

  3. Han Scale

    Difficult mask ventilation: Han grade ≥ II

    Time frame: during ventilation

Other outcomes

  1. Airway-related complications

    Number of intubation attempts and need for airway adjuncts (stylet/bougie) and complications including desaturation and dental or soft tissue injury

    Time frame: during anesthesia induction

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Udayakumar GS, Priya L, Narayanan V. Comparison of Ultrasound Parameters and Clinical Parameters in Airway Assessment for Prediction of Difficult Laryngoscopy and Intubation: An Observational Study. Cureus. 2023 Jul 5;15(7):e41392. doi: 10.7759/cureus.41392. eCollection 2023 Jul. PubMed 37546081 ↗
  • Kaul R, Singh D, Prakash J, Priye S, Kumar S, Bharati. Ultrasound Guided Measurement of Anterior Neck Tissue for the Prediction of Difficult Airway: A Prospective Observational Study. Rom J Anaesth Intensive Care. 2022 Dec 29;28(2):105-110. doi: 10.2478/rjaic-2021-0018. eCollection 2021 Dec. PubMed 36844111 ↗
  • Akin S, Yildirim M, Artas H, Bolat E. Predicting difficult airway in morbidly obese patients using ultrasound. Turk J Med Sci. 2023 Nov 21;54(1):262-274. doi: 10.55730/1300-0144.5787. eCollection 2024. PubMed 38812631 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared due to institutional data protection policies and the absence of participant consent for data sharing beyond the scope of the study.

08

Registry details

Key details

Study ID
NCT07346768
Lead sponsor
Gaziantep City Hospital
Responsible party
Gamze Nur Teke (Principal Investigator, Gaziantep City Hospital) — Principal investigator
First posted
Jan 16, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
Oct 20, 2026 (estimated)
Completion
Nov 20, 2026 (estimated)
Last update
Sep 10, 2026

Study contacts

Gamze Nur Teke, medical doctor
Contact
gamzenur.koca@gmail.com
+905546634389
Gamze Nur Teke
Contact
gamzenur.koca@gmail.com
Gamze Nur Teke, medical doctor
principal investigator · Gaziantep City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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