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Набор скоро начнётся NCT07355608

Videolaryngoscopic Difficult ıntubation and Glottic View Score: A Multicentre Prospective Study

— Наблюдательное Airway Management

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Airway Management. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Prediction of Difficult Videolaryngoscopic Intubation and Development of a Dedicated Glottic View Score: A Multicentre Prospective Study

Обзор

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.

Подробное описание

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.

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

Первичные конечные точки

  • Failed first intubation attempt [Срок оценки: 2 minutes after anesthesia induction]
  • Difficult intubation [Срок оценки: 2 minutes after anesthesia induction]
  • Failed intubation [Срок оценки: 2 minutes after anesthesia induction]
  • Intubation duration [Срок оценки: 2 minutes after anesthesia induction]
  • Glottic view description [Срок оценки: 2 minutes after anesthesia induction]
Вторичные конечные точки (2)
  • Percentil of glottic opening score [Срок оценки: 2 minutes after anesthesia induction]
  • Cormack lehanne score [Срок оценки: 2 minutes after anesthesia induction]

Критерии участия

Критерии включения

  • Adults
  • Both with normal or predicted difficult airways
  • Undergoing orotracheal intubation with a videolarygoscope

Критерии исключения

  • Rapid sequence intubation
  • Double lumen tube intubation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 2 центра
  • Etlik City Hospital — Ankara
  • Akdeniz University Medical Faculty — Antalya

Публикации

  • Xia M, Jin C, Zheng Y, Wang J, Zhao M, Cao S, Xu T, Pei B, Irwin MG, Lin Z, Jiang H. Deep learning-based facial analysis for predicting difficult videolaryngoscopy: a feasibility study. Anaesthesia. 2024 Apr;79(4):399-409. doi: 10.1111/anae.16194. Epub 2023 Dec 13. PMID 38093485
  • O'Loughlin EJ, Swann AD, English JD, Ramadas R. Accuracy, intra- and inter-rater reliability of three scoring systems for the glottic view at videolaryngoscopy. Anaesthesia. 2017 Jul;72(7):835-839. doi: 10.1111/anae.13837. Epub 2017 Mar 24. PMID 28337769

Идентификаторы

NCT: NCT07355608 · Etlik City Hospital

Первоисточники (государственные реестры)

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