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Набор скоро начнётся NCT06892405

Airway US in Predicting Difficult Pediatric Laryngoscopy

Наблюдательное Airway Complication of Anesthesia

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: SonoSite™ S Series ultrasound.
Кому может быть актуально
Состояния в реестре: Airway Complication of Anesthesia. Базовые параметры: 2 лет — 6 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
Египет
Следующий шаг
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Официальное название

Using Ultrasound to Predict the Difficulty of Direct Laryngoscopy in Pediatrics.

Обзор

The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.

Подробное описание

Current advances in airway management training have reduced the risk associated with an unanticipated DL but have not been able to reduce its incidence in clinical practice. The addition of new video laryngoscopes in our clinical practice seems to offer a paradigm shift to face a DL with promising results. However, theses authors also indicated that expertise in video laryngoscopy requires prolonged training and practice. Otherwise, a growing number of publications have showed that some ultrasound measurements may improve our anticipation of a DL because of its high accuracy to offer detailed anatomical images of the airway, absence of ionizing radiations, accessibility and reproducibility. Among all the ultrasound parameters studied, distance from skin to epiglottis with a cut-off point of 2.10 cm, showed the best predictive ability with a sensitivity of 83.33%3 and a specificity of 73.33%, for predicting difficulty in airway management in routine clinical practice. The aim of this study is to investigate the efficacy of US-measured airway structures in predicting difficult laryngoscopy (defined as CL grade III and IV).

Вмешательства

  • Устройство SonoSite™ S Series ultrasound
    US measurements will be performed in the pre-operating room a , patients are placed in supine position with the head in a sniffing position on a surgical pillow and using the 15 MHz linear array transducer of the SonoSite™ S Series ultrasound in transverse position. A scan is made from the skin surface of the floor of the mouth to the trachea exerting the minimum possible pressure to identify the structures correctly.

Первичные конечные точки

  • prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). [Срок оценки: Preoperative]
Вторичные конечные точки (3)
  • The Modified Mallampati Score (MMS). [Срок оценки: At Intubation]
  • The thyromental distance (TMD) [Срок оценки: preoperative]
  • The upper lip bite test (ULBT) [Срок оценки: Preoperative]

Критерии участия

Критерии включения

  • Gender both males and females
  • ASA Class I and II
  • Age 2 years to 6
  • Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.

Критерии исключения

  • Congenital upper airway malformation,
  • Head and neck swellings,
  • Scars,
  • Radiation to the neck,
  • Tracheotomy,

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Assiut university Pediatric hospital — Asyut

Идентификаторы

NCT: NCT06892405 · 04-2024-201007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗