- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07609147
Ultrasound Measurement of Skin-to-Epiglottis Distance for Prediction of Difficult Airway in Adult Patients
20. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
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
Undersøgelsestype
Observationel
Tilmelding (Anslået)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Almıla G Pamuk, Doç. Dr.
- Telefonnummer: 03123051207 9005335296325
- E-mail: gulsunp@yahoo.com
Undersøgelse Kontakt Backup
- Navn: muhammed r hız, research assistant
- Telefonnummer: 9003123051207 9005417800327
- E-mail: drrasithiz@gmail.com
Studiesteder
-
-
Altındağ
-
Ankara, Altındağ, Tyrkiet (Türkiye), 06320
- Hacettepe Univercity
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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]
Beskrivelse
Inclusion Criteria:
- ≥18 yaş elective surgery
Exclusion Criteria:
- emergency surgery
- head and neck surgery
- pregnant patients
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Skin-to-epiglottis distance
Tidsramme: Pre-intubation (within 30 minutes before procedure)
|
Distance measured via ultrasound in the anterior neck region
|
Pre-intubation (within 30 minutes before procedure)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of difficult laryngoscopy (Cormack-Lehane grade ≥ 3)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Preoperative assessment
|
Correlation between tracheal diameter and skin-to-epiglottis distance measured by ultrasound and preoperative Mallampati classification.
|
Preoperative assessment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Almıla g Pamuk, Doç Dr., Hacettepe Univercity
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
4. december 2026
Datoer for studieregistrering
Først indsendt
20. maj 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SBA 26/158
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Diffuculty airway
IPD-delingstidsramme
10/2026 -- 01/2027
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Luftvejsvurdering
-
AdventHealthAfsluttetDudoenoscope Assessment ToolForenede Stater
-
University of Southern CaliforniaAfsluttetTotal Body Water AssessmentForenede Stater
-
Edwards LifesciencesAfsluttetHjerteoutput og Preload Assessment | LungevandsvurderingTyskland, Schweiz
-
Wake Forest University Health SciencesAfsluttetSelf Geriatric Assessment Measure (SGAM)Forenede Stater
-
University of MalayaUkendtGenerel anæstesi | Supraglottic Airway Device | Larynx maske Airway
-
Masarykova Nemocnice v Usti nad Labem, Krajska...AfsluttetSupraglottic AirwayTjekkiet
-
Masarykova Nemocnice v Usti nad Labem, Krajska...Ikke rekrutterer endnuSupraglottic Airway
-
Ann & Robert H Lurie Children's Hospital of ChicagoAfsluttetSupraglottic AirwayForenede Stater
-
The University of Texas Health Science Center,...Ambu A/SAfsluttetSupraglottic AirwayForenede Stater
-
Cancer Institute and Hospital, Chinese Academy...Ukendt