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Obesity (BMI > 35)NCT07528677

Ultrasound vs Clinical Parameters for Difficult Airway Prediction in Obesity

An observational study of Obesity (BMI > 35) and Difficult Airway, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

Obesity is associated with anatomical changes in the upper airway that increase the risk of difficult laryngoscopy and difficult mask ventilation during anesthesia. Conventional airway assessment parameters such as Mallampati score, neck circumference, and STOP-BANG scale are widely used but have limited predictive… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Airway Ultrasonography
Type of treatment
Injection or infusion
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Apr 2026to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult obese patients (BMI >30 kg/m², aged 18-65 years, ASA I-III) scheduled for elective surgery requiring orotracheal intubation under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.

Who may be able to join

  • Age 18-65 years
  • BMI >30 kg/m2
  • ASA physical status I, II, or III
  • Scheduled for elective surgery requiring orotracheal intubation under general anesthesia
  • Written informed consent obtained

Who cannot join

  • Emergency surgery
  • History of previous head and neck surgery or radiotherapy
  • Known or anticipated difficult airway (history of difficult intubation)
  • Presence of cervical spine pathology or limited neck mobility
  • Presence of oropharyngeal or laryngeal pathology
  • Pregnancy
  • Patients with tracheostomy
  • Refusal to participate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emin Mert Koyutürk, MD contact

+905362403394

mertkytrk@gmail.com

Turkey (Türkiye)1 site
  • Fatih Sultan Mehmet Training and Research Hospital

    Istanbul

    cansu ofluoglu, MD, +905358640564, cansuakin.iu@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Airway Ultrasonography and Conventional Difficult Airway Parameters for Predicting Difficult Airway in Obese Patients: A Prospective Observational Study

Obesity is associated with anatomical changes in the upper airway that increase the risk of difficult laryngoscopy and difficult mask ventilation during anesthesia. Conventional airway assessment parameters such as Mallampati score, neck circumference, and STOP-BANG scale are widely used but have limited predictive accuracy in obese patients. Airway ultrasonography has emerged as a promising non-invasive tool for difficult airway prediction; however, ultrasonographic criteria have not yet been standardized.

This prospective observational study aims to evaluate the utility of airway ultrasonography in predicting difficult airway in adult obese patients (BMI >30 kg/m²) scheduled for elective surgery under general anesthesia. Ultrasonographic measurements will include the distance from skin to hyoid bone (DSHB) at the level of the hyoid bone, the anterior neck soft tissue thickness at the thyrohyoid membrane level, and the hyomental distance ratio (HMDR). These parameters will be compared with conventional airway assessment tools and correlated with intraoperative Cormack-Lehane laryngoscopy grade and Han Scale mask ventilation score to determine their predictive value for difficult airway.

Read the detailed description

Airway management is a critical component of clinical anesthesia. A difficult airway is defined as a situation in which a conventionally trained anesthesiologist experiences difficulty with mask ventilation, laryngoscopy, supraglottic airway ventilation, tracheal intubation, extubation, or invasive airway management. Unanticipated difficult laryngoscopy and difficult mask ventilation can lead to catastrophic outcomes. The incidence of difficult laryngoscopy and intubation is estimated at 1.5-13%, and approximately 28% of anesthesia-related deaths are attributable to failed mask ventilation or intubation.

Obesity (BMI ≥30 kg/m²) is associated with significant anatomical alterations in the upper airway and head and neck region. Accumulation of adipose tissue in the pharynx and hypopharynx narrows the airway lumen. A larger tongue is more difficult to displace into the submental space during laryngoscopy. Enlarged tonsils further reduce oropharyngeal space. Fat deposition in the neck, shoulders, and back complicates optimal patient positioning for laryngoscopy. Excessive soft tissue around the face and cheeks impairs effective mask seal and ventilation.

With advances in portable ultrasound technology, airway ultrasonography has become an increasingly utilized clinical tool for preoperative airway assessment. However, ultrasonographic criteria for predicting difficult airway have not yet been standardized.

Study Protocol:

Adult obese patients (BMI >30 kg/m², aged 18-65 years, ASA I-III) scheduled for elective surgery requiring orotracheal intubation under general anesthesia will be enrolled. Prior to the operating room, the following conventional airway parameters will be assessed: neck circumference, Mallampati score, and STOP-BANG scale. Airway ultrasonographic measurements will be performed preoperatively and will include:

Distance from skin to hyoid bone (DSHB) at the transverse view of the hyoid bone level Anterior neck soft tissue thickness at the thyrohyoid membrane level Hyomental distance ratio (HMDR): ratio of hyomental distance in extension (HMDe) to hyomental distance in neutral position (HMDn)

Upon arrival to the operating room, standard monitoring will be applied including electrocardiogram (ECG), non-invasive blood pressure, peripheral oxygen saturation (SpO2), body temperature, and bispectral index (BIS). Following monitoring and preoxygenation (2 minutes with 100% oxygen via face mask), standard anesthesia induction will be performed with intravenous propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6 mg/kg. After adequate neuromuscular blockade, orotracheal intubation will be performed.

Mask ventilation difficulty will be graded using the Han Scale during the mask ventilation phase. Laryngoscopy difficulty will be graded using the Cormack-Lehane classification at the time of intubation.

Mechanical ventilation will be maintained in volume control mode with tidal volume of 6-8 ml/kg, targeting end-tidal CO2 (EtCO2) of 35-40 mmHg. Anesthesia maintenance will be provided with 1.5-2% sevoflurane in 50% O2/air at 2 L/min and intravenous remifentanil infusion at 0.05-0.5 mcg/kg/min, targeting BIS 40-60. Normothermia will be maintained with an active forced-air warming device throughout the procedure.

Twenty minutes before the end of surgery, standard postoperative analgesia and prophylaxis will be administered: paracetamol 1 g, tramadol 1 mg/kg, and ondansetron 4 mg intravenously. Heart rate, blood pressure, EtCO2, and SpO2 will be documented every 30 minutes intraoperatively.

At the end of surgery, anesthetic agents will be discontinued. Sugammadex 2 mg/kg IV will be administered for reversal of neuromuscular blockade upon return of spontaneous respiratory effort. Patients with adequate respiratory effort and BIS ≥85 will be extubated and transferred to the post-anesthesia care unit (PACU) when conscious, with recovered muscle strength and hemodynamic stability. Standard monitoring will continue in the PACU prior to ward transfer.

Primary Outcome: Preoperative ultrasonographic assessment of anterior neck using DSHB and HMDR parameters and their correlation with intraoperative Cormack-Lehane grade.

Secondary Outcome: Determination of whether DSHB and HMDR can predict difficult airway in adult obese patients when correlated with Cormack-Lehane laryngoscopy grade and Han Scale mask ventilation score.

Being tested
Airway Ultrasonography
Keywords
Airway ultrasonography, Difficult airway prediction, Obese patients, Cormack-Lehane classification, Han Scale, Hyomental distance ratio, Distance from skin to hyoid bone, Neck circumference, Mallampati score, STOP-BANG scale, General anesthesia, Orotracheal intubation
Medical subject headings
Obesity

What participants receive

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

  • Airway UltrasonographyDiagnostic test

    Preoperative airway ultrasonography will be performed by a trained anesthesiologist using a linear ultrasound probe with the patient in the supine position and head in neutral position. The following measurements will be obtained: (1) minimum distance from skin to hyoid bone (DSHB) at the transverse view of the hyoid bone level, (2) anterior neck soft tissue thickness at the thyrohyoid membrane level, and (3) hyomental distance ratio (HMDR), calculated as the ratio of hyomental distance in full extension (HMDe) to hyomental distance in neutral position (HMDn). These ultrasonographic parameters will be correlated with intraoperative Cormack-Lehane laryngoscopy grade and Han Scale mask ventilation score to assess their predictive value for difficult airway in obese patients.

Study groups in NCT07528677
Study groupRoleWhat they receive
Obese Patients Undergoing General AnesthesiaAdult obese patients (BMI >30 kg/m², aged 18-65 years, ASA I-III) scheduled for elective surgery requiring orotracheal intubation under general anesthesia. Preoperative airway assessment will include conventional parameters (Mallampati score, neck circumference, STOP-BANG scale) and airway ultrasonographic measurements (distance from skin to hyoid bone [DSHB] and hyomental distance ratio [HMDR]). Standard anesthesia induction will be performed with propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6 mg/kg. Mask ventilation difficulty will be graded using the Han Scale and laryngoscopy difficulty using the Cormack-Lehane classification. Anesthesia will be maintained with sevoflurane and remifentanil infusion targeting BIS 40-60.
Receives: Diagnostic Test: Airway Ultrasonography

What is being measured

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

  1. Correlation of Ultrasonographic Airway Parameters (DSHB and HMDR) with Cormack-Lehane Laryngoscopy Grade

    Preoperative ultrasonographic measurements including the minimum distance from skin to hyoid bone (DSHB) at the hyoid bone level and the hyomental distance ratio (HMDR, calculated as hyomental distance in full extension divided by hyomental distance in neutral position) will be correlated with the intraoperative Cormack-Lehane laryngoscopy grade. Cormack-Lehane grades III and IV will be defined as difficult laryngoscopy. The diagnostic accuracy of DSHB and HMDR in predicting difficult laryngoscopy will be assessed using ROC curve analysis.

    Measured: Perioperative/Periprocedural

Secondary outcomes (2)
  1. Predictive Value of Conventional Airway Parameters for Difficult Laryngoscopy

    Conventional preoperative airway assessment parameters including Mallampati score, neck circumference, and STOP-BANG scale will be correlated with intraoperative Cormack-Lehane laryngoscopy grade. Cormack-Lehane grades III and IV will be defined as difficult laryngoscopy. The diagnostic accuracy of each conventional parameter will be assessed using ROC curve analysis and compared with ultrasonographic parameters.

    Measured: Perioperative/Periprocedural

  2. Predictive Value of Ultrasonographic and Conventional Airway Parameters for Difficult Mask Ventilation

    Preoperative ultrasonographic measurements (DSHB and HMDR) and conventional airway parameters (Mallampati score, neck circumference, STOP-BANG scale) will be correlated with intraoperative mask ventilation difficulty graded using the Han Scale. Han Scale grades III and IV will be defined as difficult mask ventilation. Diagnostic accuracy of each parameter will be assessed using ROC curve analysis.

    Measured: Perioperative/Periprocedural

Timeline

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

  1. First posted14 Apr 2026
  2. Study start10 Apr 2026 (estimated)
  3. Primary completion10 Oct 2026 (estimated)
  4. Study completionNov 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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07528677
Sponsor's protocol ID
FSMAİRWAY
Status last verified
Apr 2026
First submitted
27 Mar 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity (BMI > 35) and Difficult Airway, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emin Mert Koyutürk, MD (+905362403394, mertkytrk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of Ultrasonographic Airway Parameters (DSHB and HMDR) with Cormack-Lehane Laryngoscopy Grade (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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