Меню
Идёт набор NCT06925009

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

— 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.

Подробное описание

Tracheal intubation is a routine procedure in anaesthesia and critical care; however, difficulties during videolaryngoscopy may still occur despite advances in airway devices. Conventional bedside airway assessments provide limited guidance for videolaryngoscopy-specific decisions, such as blade selection or anticipation of adjunct use.

This unicentric observational study collects clinical characteristics, demographic data, and point-of-care airway ultrasound measurements in patients undergoing videolaryngoscopy. These variables are analysed using machine-learning techniques to examine their association with predefined videolaryngoscopy-related outcomes, including blade performance and adjunct requirement.

The primary objective is to develop and internally evaluate a predictive model integrating multimodal data to support videolaryngoscopy strategy planning. The model is intended solely as a research and decision-support tool and does not replace clinician judgement. External validation in independent cohorts is planned.

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: 5 minutes]
  • Distance from skin to epiglottis measured with lineal ultrasound probe [Срок оценки: 5 minutes]
  • Tongue Thickness measured with convex probe [Срок оценки: 5 minutes]
  • Distance from Jaw to Hyoid bone distance measured with convex probe [Срок оценки: 5 minutes]
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: 1minute]
  • Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended [Срок оценки: 1minute]
  • 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: 1minute]
  • Interincisor distance DIstance in centimeters between fornt incisors [Срок оценки: 1minute]
  • 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: 1minute]
  • neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured [Срок оценки: 1minute]

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

Публикации

  • Fernandez-Vaquero MA, Oyarzun-Silva R, Hernandez-Hernandez P, Gomez-Rios MA, Petrisor C, Falcetta S, Gomes SH, De Luis-Cabezon N. Airway coach project: development of a machine learning-based model using clinical and ultrasound parameters to support videolaryngoscopy strategy. BMC Anesthesiol. 2026 Jun 18. doi: 10.1186/s12871-026-03943-4. Online ahead of print. PMID 42316024

Идентификаторы

NCT: NCT06925009 · MAFV 1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗