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.
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
- Conditions the study is for
- Ultrasonography, Airway Management, Intubation, Intratracheal
- 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 contact
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 group | Role | What they receive |
|---|---|---|
| Overweight and Obese Surgical Patients | Adult 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.
Cormack-Lehane grade III-IV
Occurrence of difficult airway during anesthesia induction, defined by difficult laryngoscopy
Measured: During anesthesia induction
Secondary outcomes (3)
Ultrasound-derived anterior neck soft tissue measurements
diagnostic accuracy for predicting difficult airway (ROC-AUC)
Measured: During anesthesia induction
Intubation Difficulty Scale (IDS) score
Difficult intubation: IDS score > 5
Measured: during tracheal intubation
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.
- First posted16 Jan 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur Teke, Gaziantep City Hospital
- Investigators
- Gamze Nur Teke, medical doctor, Principal investigator, Gaziantep City Hospital
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 37546081Kaul 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 36844111Akin 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