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Идёт набор NCT06881589

Airway Coach Project: Prediction of Videolaryngoscopy Strategy With Clinical and Ultrasound Parameters (Multicentric)

Наблюдательное Difficult Videolaryngoscopy

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
В протоколе указаны: Ultrasound mesurements.
Кому может быть актуально
Состояния в реестре: Difficult Videolaryngoscopy. Базовые параметры: 18 лет — 90 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This multicentre observational study will collect clinical parameters, demographic data, and point-of-care airway ultrasound measurements from adult patients undergoing videolaryngoscopy across participating centres. The collected data will be analysed using artificial intelligence-based analytical approaches, including statistical and machine-learning techniques, to examine their association with predefined videolaryngoscopy-related outcomes.

Подробное описание

Videolaryngoscopy is widely used for tracheal intubation in anaesthesia and critical care; however, variability in patient anatomy, operator experience, and institutional practice may influence videolaryngoscopy performance and strategy selection. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decision-making, particularly in diverse clinical environments.

This multicentre observational study will collect clinical parameters, demographic data, and point-of-care airway ultrasound measurements from adult patients undergoing videolaryngoscopy across participating centres. The collected data will be analysed using artificial intelligence-based analytical approaches, including statistical and machine-learning techniques, to examine their association with predefined videolaryngoscopy-related outcomes.

The primary objective is to evaluate the performance and generalisability of multimodal predictive models developed using multicentre data. The study is designed to support the development and validation of data-driven decision-support tools for videolaryngoscopy planning. These tools are intended for research purposes and do not replace clinical judgement.

Вмешательства

  • Диагностический тест Ultrasound mesurements
    Compare various clinical test with ultrasound parameters to predict difficult videolaryngoscopy intubation.

Первичные конечные точки

  • Distance from skin to Hyoid bone measured with lineal ultrasound probe [Срок оценки: Immediately prior to induction of anesthesia]
  • Distance from skin to epiglottis measured with lineal ultrasound probe [Срок оценки: Immediately prior to induction of anesthesia]
  • Tongue Thickness measured with convex probe [Срок оценки: Immediately prior to induction of anesthesia]
  • Distance from Jaw to Hyoid bone distance measured with convex probe [Срок оценки: Immediately prior to induction of anesthesia]
Вторичные конечные точки (6)
  • Modified Mallampati Score Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible. [Срок оценки: Immediately prior to induction of anesthesia]
  • Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended [Срок оценки: Immediately prior to induction of anesthesia]
  • Sternomental distance the distance from the suprasternal notch to the mentum and is measured with the head fully extended on the neck and the mouth closed [Срок оценки: Immediately prior to induction of anesthesia]
  • Interincisor distance DIstance in centimeters between fornt incisors [Срок оценки: Immediately prior to induction of anesthesia]
  • Upper Lip Bite Test upper lip bite criteria-class I = lower incisors can bite the upper lip above the vermilion line, class II = lower incisors can bite the upper lip below the vermilion line, and class III = lower incisors cannot bite the upper lip [Срок оценки: Immediately prior to induction of anesthesia]
  • neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured [Срок оценки: Immediately prior to induction of anesthesia]

Критерии участия

Критерии включения

  • Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

Критерии исключения

  • Obesity class II defined as a BMI greater than 35.
  • Pregnant.
  • Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
  • Abnormalities that condition anatomy alterations such as facial / cervical fractures.
  • Maxillofacial abnormalities
  • People who cannot give their consent

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

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Испания · 1 центр
  • Clinica Universidad de Navarra — Madrid

Идентификаторы

NCT: NCT06881589 · MAFV 2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗