Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
NCT07723430
Airway Management, Endotracheal Intubation
View Trial DetailsNCT Number: NCT07355608
Background:
Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation.
Objectives:
This study aims to:
1. Develop a predictive model for difficult VL intubation in surgical patients with both normal and anticipated difficult airways. 2. Create a glottic view scoring system specifically tailored to videolaryngoscopy. 3. Compare the predictive accuracy of the new scoring system with existing laryngeal view grades in forecasting difficult VL intubation.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
Etlik City Hospital, Ankara, Turkey (Türkiye)
Background:
Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation.
Objectives:
This study aims to:
Methods:
A prospective cohort of 4,977 patients will be enrolled. Patient and intubation related variables-including VL findings, airway features, clinical parameters, device, and procedural details-will be analyzed. Binary logistic regression will be employed to build the initial predictive model. In parallel, machine learning techniques (Random Forest, Support Vector Machine, XGBoost, LightGBM, etc.) will be applied to evaluate predictive performance. Comparative analysis will be conducted between the machine learning models and the logistic regression baseline.
Expected Impact:
The development of a robust predictive tool and an associated VL-specific glottic view score could enhance clinical decision making, particularly in identifying patients at risk of difficult or failed VL intubation. This may support early consideration of awake tracheal intubation, and use of standardized terminology and reduce complications associated with difficult airway management
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 minutes after anesthesia induction
Failed to intubate at firtst attempt
Time frame: 2 minutes after anesthesia induction
Failed to intubate at 1-2 attempts and/or intubation duration longer than 120 second
Time frame: 2 minutes after anesthesia induction
Not able to intubate the patient
Time frame: 2 minutes after anesthesia induction
Time elapsed from entring the blade between the teeth to detecting an entidal carbondioxide trace
Time frame: 2 minutes after anesthesia induction
Vocal cords are fully visible Vocal cords are partially separately Vocal cords are not visible Cords are adducted Epiglottis is visible Epiglottis is large Epiglottis is small Epiglottis is edematous Epiglottis mass is present Arytenoids are visible Arytenoid luxation or subluxation Arytenoid edema Valecula problem (edema, Coffee grounds, etc., unable to insert a blade) Aryepiglottic plica pathology (edema, Coffee grounds scar) Laryngeal structures should be formed Glottic stenosis Laryngospasm
Time frame: 2 minutes after anesthesia induction
the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the inter-arytenoid notch
Time frame: 2 minutes after anesthesia induction
grade 1 being a full view of the glottis, grade 2 being a partial view, grade 3 being only a view of the epiglottis, and grade 4 being an absent view of the glottis and epiglottis
Contact information is provided by the study sponsor or research team.
Dilek Yazıcıoğlu Ünal, Professor
CONTACT
Emel Gündüz, assoc.
CONTACT
Diskapi Teaching and Research Hospital
Other
Prediction of Difficult Videolaryngoscopic Intubation and Development of a Dedicated Glottic View Score: A Multicentre Prospective Study
Acronym: VIDIGLOV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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