NCT07609147

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2026

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Keywords

ultrasoundairwaytracheaepiglottisSkin-to-Epiglottis DistanceDifficult Airway Prediction

Outcome Measures

Primary Outcomes (1)

  • Skin-to-epiglottis distance

    Distance measured via ultrasound in the anterior neck region

    Pre-intubation (within 30 minutes before procedure)

Secondary Outcomes (3)

  • Incidence of difficult laryngoscopy (Cormack-Lehane grade ≥ 3)

    During intubation procedure (intraoperative period)

  • Intubation Difficulty Score (IDS)

    During intubation procedure

  • Correlation between ultrasound measurements and Mallampati score

    Preoperative assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 \[Hacettepe University Faculty of Medicine\]

You may qualify if:

  • ≥18 yaş elective surgery

You may not qualify if:

  • emergency surgery
  • head and neck surgery
  • pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Univercity

Ankara, Altındağ, 06320, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    BACKGROUND
  • 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.

    PMID: 30139232BACKGROUND
  • 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.

    PMID: 41203471BACKGROUND
  • 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.

    PMID: 40142901BACKGROUND
  • 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.

    PMID: 39176250BACKGROUND
  • 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.

    PMID: 39029084BACKGROUND
  • 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.

    PMID: 32346164BACKGROUND
  • 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.

    PMID: 34217221BACKGROUND
  • 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.

    PMID: 21447488BACKGROUND
  • 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.

    PMID: 40499971BACKGROUND
  • 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.

    PMID: 29889671BACKGROUND

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Almıla g Pamuk, Doç Dr.

    Hacettepe Univercity

    STUDY DIRECTOR

Central Study Contacts

Almıla G Pamuk, Doç. Dr.

CONTACT

muhammed r hız, research assistant

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doç. Dr.

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 4, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Diffuculty airway

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
10/2026 -- 01/2027

Locations