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UltrasonographyNCT07346768

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

An observational study of Ultrasonography and Airway Management, run by Gaziantep City Hospital.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
None (Observational study)
How many people
52 participants
Where
No sites listed yet
Study dates
20 Sep 2026to 20 Nov 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Overweight and obese adult patients undergoing elective surgery under general anesthesia

Who may be able to join

  • Age 18-70 years
  • ASA physical status I-III
  • BMI >25 kg/m²
  • Scheduled for elective surgery under general anesthesia

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gamze Nur Teke, medical doctor contact

+905546634389

gamzenur.koca@gmail.com

Gamze Nur Teke contact

gamzenur.koca@gmail.com

About this study

Official title: Ultrasound Assessment of Anterior Neck Soft Tissue Thickness to Predict Difficult Airway Risk in Obese Patients Undergoing for Surgery Under General Anesthesia: an Observational Study

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.

Being tested
None (Observational study)
Keywords
Obesity, difficult airway, anterior neck ultrasound, ultrasonography
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None (Observational study)Other

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

Study groups in NCT07346768
Study groupRoleWhat they receive
Overweight and Obese Surgical PatientsAdult overweight and obese patients undergoing elective surgery under general anesthesia who will receive standard care airway management.
Receives: Other: None (Observational study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cormack-Lehane grade III-IV

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

    Measured: During anesthesia induction

Secondary outcomes (3)
  1. Ultrasound-derived anterior neck soft tissue measurements

    diagnostic accuracy for predicting difficult airway (ROC-AUC)

    Measured: During anesthesia induction

  2. Intubation Difficulty Scale (IDS) score

    Difficult intubation: IDS score > 5

    Measured: during tracheal intubation

  3. Han Scale

    Difficult mask ventilation: Han grade ≥ II

    Measured: during ventilation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start20 Sep 2026 (estimated)
  3. Primary completion20 Oct 2026 (estimated)
  4. Study completion20 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07346768
Sponsor's protocol ID
GaziantepCH
Status last verified
Jan 2026
First submitted
8 Jan 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

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