- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609147
Ultrasound Measurement of Skin-to-Epiglottis Distance for Prediction of Difficult Airway in Adult Patients
May 20, 2026 updated by: Almıla Gulsun Pamuk, Hacettepe University
This prospective observational study aims to evaluate the predictive value of ultrasound-measured skin-to-epiglottis distance for difficult airway in adult patients undergoing elective or emergency procedures requiring airway management.
The correlation between ultrasound measurements and standard airway assessment parameters will be analyzed.
Study Overview
Status
Not yet recruiting
Detailed Description
Airway management is a critical component of anesthesia and intensive care practice.
Predicting difficult airway remains challenging with conventional bedside tests.
Ultrasound has emerged as a non-invasive, bedside tool for airway assessment.
This study aims to investigate the relationship between skin-to-epiglottis distance measured by ultrasound and difficult laryngoscopy/intubation. Secondary comparisons will include traditional airway assessment methods such as Mallampati score, thyromental distance, and neck circumference
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Almıla G Pamuk, Doç. Dr.
- Phone Number: 03123051207 9005335296325
- Email: gulsunp@yahoo.com
Study Contact Backup
- Name: muhammed r hız, research assistant
- Phone Number: 9003123051207 9005417800327
- Email: drrasithiz@gmail.com
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey (Türkiye), 06320
- Hacettepe Univercity
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study population consists of adult patients scheduled for elective surgery requiring tracheal intubation under general anesthesia.
Patients will be recruited from the preoperative anesthesia clinic at [Hacettepe University Faculty of Medicine]
Description
Inclusion Criteria:
- ≥18 yaş elective surgery
Exclusion Criteria:
- emergency surgery
- head and neck surgery
- pregnant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin-to-epiglottis distance
Time Frame: Pre-intubation (within 30 minutes before procedure)
|
Distance measured via ultrasound in the anterior neck region
|
Pre-intubation (within 30 minutes before procedure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of difficult laryngoscopy (Cormack-Lehane grade ≥ 3)
Time Frame: During intubation procedure (intraoperative period)
|
The proportion of patients with difficult laryngoscopy defined as Cormack-Lehane grade 3 or 4 during direct laryngoscopy.
|
During intubation procedure (intraoperative period)
|
|
Intubation Difficulty Score (IDS)
Time Frame: During intubation procedure
|
Assessment of intubation difficulty using the Intubation Difficulty Score based on number of attempts, operators, alternative techniques, glottic exposure, lifting force, external laryngeal pressure, and vocal cord position.
|
During intubation procedure
|
|
Correlation between ultrasound measurements and Mallampati score
Time Frame: Preoperative assessment
|
Correlation between tracheal diameter and skin-to-epiglottis distance measured by ultrasound and preoperative Mallampati classification.
|
Preoperative assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Almıla g Pamuk, Doç Dr., Hacettepe Univercity
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
- Falcetta S, Cavallo S, Gabbanelli V, Pelaia P, Sorbello M, Zdravkovic I, Donati A. Evaluation of two neck ultrasound measurements as predictors of difficult direct laryngoscopy: A prospective observational study. Eur J Anaesthesiol. 2018 Aug;35(8):605-612. doi: 10.1097/EJA.0000000000000832.
- Gani, E. (2020). Obez hastalarda zor entübasyonun öngörülmesinde ultrasonla ölçülen cilt-epiglot mesafesinin önemi (Tıpta Uzmanlık Tezi). Düzce Üniversitesi, Tıp Fakültesi, Anesteziyoloji ve Reanimasyon Anabilim Dalı, Düzce.
- Uzumcugil F, Celebioglu EC, Ozkaragoz DB, Yilbas AA, Akca B, Lotfinagsh N, Celebioglu B. Body Surface Area Is Not a Reliable Predictor of Tracheal Tube Size in Children. Clin Exp Otorhinolaryngol. 2018 Dec;11(4):301-308. doi: 10.21053/ceo.2018.00178. Epub 2018 Aug 25.
- Ahmad I, El-Boghdadly K, Iliff H, Dua G, Higgs A, Huntington M, Mir F, Nouraei SAR, O'Sullivan EP, Patel A, Rivett K, McNarry AF. Difficult Airway Society 2025 guidelines for management of unanticipated difficult tracheal intubation in adults. Br J Anaesth. 2026 Jan;136(1):283-307. doi: 10.1016/j.bja.2025.10.006. Epub 2025 Nov 7.
- Altinsoy KE, Bayhan BU. Ultrasound-Measured Skin-to-Epiglottis Distance as a Predictor of Difficult Intubation in Obese Patients: A Prospective Observational Study. J Clin Med. 2025 Mar 19;14(6):2092. doi: 10.3390/jcm14062092.
- Sayir TN, Tuncer B, Erkilic E. Evaluation of upper airway ultrasonographic measurements in predicting difficult intubation: A cross-section of the Turkish population. Open Med (Wars). 2024 Aug 21;19(1):20241013. doi: 10.1515/med-2024-1013. eCollection 2024.
- Cinar Kose EO, Tekin M, Cesur S, Cam I, Baykara ZN. Evaluation of neck ultrasound measurements as a difficult airway predictor: A prospective observational study. Medicine (Baltimore). 2024 Jul 19;103(29):e38591. doi: 10.1097/MD.0000000000038591.
- Daggupati H, Maurya I, Singh RD, Ravishankar M. Development of a scoring system for predicting difficult intubation using ultrasonography. Indian J Anaesth. 2020 Mar;64(3):187-192. doi: 10.4103/ija.IJA_702_19. Epub 2020 Mar 11.
- Sotoodehnia M, Rafiemanesh H, Mirfazaelian H, Safaie A, Baratloo A. Ultrasonography indicators for predicting difficult intubation: a systematic review and meta-analysis. BMC Emerg Med. 2021 Jul 3;21(1):76. doi: 10.1186/s12873-021-00472-w.
- Zhang W, Du L, Huang Y, Liu D, Li T, Zheng J. Artificial intelligence for difficult airway assessment: a protocol for a systematic review with meta-analysis. BMJ Open. 2025 Jun 10;15(6):e096744. doi: 10.1136/bmjopen-2024-096744.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 4, 2026
Study Registration Dates
First Submitted
May 20, 2026
First Submitted That Met QC Criteria
May 20, 2026
First Posted (Actual)
May 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBA 26/158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Diffuculty airway
IPD Sharing Time Frame
10/2026 -- 01/2027
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Airway Assessment
-
Ain Shams UniversityEnrolling by invitationAirway Ultrasound Indices | Clinical Airway AssessmentEgypt
-
Seoul National University HospitalNot yet recruiting
-
Ohio State UniversityCompleted
-
Adana City Training and Research HospitalCompletedDifficult Intubation | Airway AssessmentTurkey (Türkiye)
-
Ankara City Hospital BilkentCompletedPediatric Anesthesia | Videolaryngoscopy | Difficult Airway, Videolaryngoscopes | Airway Management AssessmentTurkey (Türkiye)
-
Kocaeli UniversityCompletedAssessment | Difficult Airway Intubation | PreoperativeTurkey
-
Kocaeli City HospitalNot yet recruitingVideolaryngoscopy | Awake Fiberoptic Nasal Intubation | Awake Endotracheal Intubation | Airway Management Assessment | Supraglottic Airway Device InsertionTurkey (Türkiye)
-
Sultan Abdulhamid Han Training and Research Hospital...RecruitingSupraglottic Airways for General Anesthesia | Airway Management Assessment | Laryngeal Mask Airways | Supraglottic AirwaysTurkey (Türkiye)
-
Rajiv Gandhi Cancer Institute & Research Center...CompletedVocal Cord Movement Assessment by Airway UltrasoundIndia
-
South Valley UniversityRecruiting