- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07628868
The Impact of Ultrasound Measurements in Predicting Difficult Airway on Videolaryngoscopy Success
Impact of Airway Ultrasound Measurements on the Success of Videolaryngoscopy in Predicting Difficult Airway
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Upper airway ultrasonography has emerged as a promising tool for difficult airway assessment by enabling non-invasive, bedside, repeatable, and objective evaluation of airway anatomy. However, a substantial proportion of the existing literature has correlated ultrasonographic measurements with direct laryngoscopy findings. Whether these measurements retain their predictive value in the setting of videolaryngoscopy, and which ultrasonographic parameters best reflect technical intubation difficulty during videolaryngoscopic intubation, remain unclear. Furthermore, several studies have proposed specific cut-off values for upper airway ultrasonographic measurements to predict difficult laryngoscopy when direct laryngoscopy is used. However, these cut-off values may not be directly applicable to videolaryngoscopy because the improved glottic visualization provided by videolaryngoscopes fundamentally alters the relationship between airway anatomy and intubation difficulty.
Therefore, after obtaining a detailed medical history, including both general medical and difficult airway-related history, all patients underwent a comprehensive airway assessment. Conventional predictors of difficult airway were evaluated, including Mallampati classification, inter-incisor distance, thyromental distance, atlanto-occipital joint extension, neck circumference, and the upper lip bite test.
On the day of surgery, ultrasonographic measurements including the distance from the skin to the epiglottis (ESD), hyomental distance (HMD), tongue thickness (TT), and tongue cross-sectional area (CSA) will be obtained. Following these assessments, patients will be transferred to the operating room, where standard general anesthesia induction will be performed. Orotracheal intubation will subsequently be carried out using a videolaryngoscope. After intubation, the difficulty of mask ventilation, laryngoscopy, and orotracheal intubation will be evaluated by the anesthesiologist using established clinical assessment tools and scoring systems.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Bakirköy
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Istanbul, Bakirköy, Turquie (Türkiye), 34147
- SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients aged 18 years and older
- Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (ASA I-III)
Exclusion Criteria:
- Patients undergoing surgery under sedation or regional anesthesia
- Patients not planned for endotracheal intubation
- Patients with a history of difficult airway
- Patients with an acute respiratory tract infection
- Patients with congenital or acquired upper airway anomalies
- Patients with facial or maxillofacial tumors or fractures
- Patients with cervical spine fracture
- Patients with a history of cervical or craniofacial radiotherapy
- Patients with a tracheostomy
- Pregnant patients
- Patients who do not meet the required fasting period or who refuse to -participate in the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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None (Orotracheal intubation will be performed using a videolaryngoscope in all patients)
Patients aged 18 years and older, classified as American Society of Anesthesiologists (ASA) physical status I-III, who will undergo surgery under general anesthesia requiring orotracheal intubation, will be included in this prospective observational study.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Difficult videolaryngoscopic intubation
Délai: During videolaryngoscopy (periprocedural)
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Difficult videolaryngoscopic intubation will be assessed using the VIDIAC score, a scoring system specifically developed to quantify intubation difficulty during videolaryngoscopy.
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During videolaryngoscopy (periprocedural)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Difficult mask ventilation
Délai: During ventilation (periprocedural)
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Difficult mask ventilation will be assessed after anesthesia induction and during ventilation.
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During ventilation (periprocedural)
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Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.
- Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
- Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.
- Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
- Gomes SH, Simoes AM, Nunes AM, Pereira MV, Teoh WH, Costa PS, Kristensen MS, Teixeira PM, Pego JM. Useful Ultrasonographic Parameters to Predict Difficult Laryngoscopy and Difficult Tracheal Intubation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 28;8:671658. doi: 10.3389/fmed.2021.671658. eCollection 2021.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2025/46
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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