NCT07346768

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 8, 2026

Last Update Submit

January 8, 2026

Conditions

Keywords

Obesitydifficult airwayanterior neck ultrasoundultrasonography

Outcome Measures

Primary Outcomes (1)

  • Cormack-Lehane grade III-IV

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

    During anesthesia induction

Secondary Outcomes (3)

  • Ultrasound-derived anterior neck soft tissue measurements

    During anesthesia induction

  • Intubation Difficulty Scale (IDS) score

    during tracheal intubation

  • Han Scale

    during ventilation

Other Outcomes (1)

  • Airway-related complications

    during anesthesia induction

Study Arms (1)

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

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

Overweight and Obese Surgical Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Overweight and obese adult patients undergoing elective surgery under general anesthesia

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityOverweight

Interventions

Observation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Gamze Nur Teke, medical doctor

    Gaziantep City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamze Nur Teke, medical doctor

CONTACT

Gamze Nur Teke

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

January 20, 2026

Primary Completion

May 20, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.