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Идёт набор NCT05884645

The DAnish VIdeo IntubaTION (DA-VITION) Study

— Наблюдательное Intubation Complication Intubation; Difficult or Failed

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: Video-directed endotracheal intubation.
Кому может быть актуально
Состояния в реестре: Intubation Complication, Intubation; Difficult or Failed. Базовые параметры: Без ограничений · 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
Дания
Следующий шаг
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Официальное название

The DAnish VIdeo IntubaTION (DA-VITION) Study: a Prospective Observational Cohort Study

Обзор

This study aims to train an AI for video-directed endotracheal intubation (VITION) to recognise the anatomical structures of the upper airway during video-directed endotracheal intubations.

Подробное описание

Study design

The VITION study protocol describes the design of a prospective, observational study. Inclusion will commence in 2023 at the anesthesia and intensive care departments in the Capital Region of Denmark.

Participants

Patients across all ages are eligible for inclusion if they are undergoing video-directed oral or nasal endotracheal intubation.

Exclusion criteria

Patients are excluded if they adhere to one of the exclusion criteria:

* Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis17,18). * Failed attempt by video laryngoscopy due to malfunctioning equipment. * Missing or corrupted video recording. * Informed consent is not obtained from the participants or participants' parents / legal guardians.

Interventions and comparisons

This prospective, observational study will have no interventions or comparisons.

Primary objective

The primary objective is to characterize anatomical landmarks and performances of intubations in a large and diverse pool of clinicians and patients.

Вмешательства

  • Процедура Video-directed endotracheal intubation
    There will be no intervention in this prospective observational cohort study. Endotracheal intubation is already used to secure the airway by placing an endotracheal tube into the trachea via the oral or nasal route. Indications include the need for airway control during general anaesthesia, mechanical ventilation, resuscitation, and various forms of acute respiratory distress.

Первичные конечные точки

  • Accuracy of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Срок оценки: The landmarks will be identified on the multimedia file from the procedure.]
  • Sensitivity of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Срок оценки: The landmarks will be identified on the multimedia file from the procedure.]
  • Specificity of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Срок оценки: The landmarks will be identified on the multimedia file from the procedure.]
  • AUC of the AI algorithm to recognise the anatomical landmarks in the upper airway. [Срок оценки: The landmarks will be identified on the multimedia file from the procedure.]
Вторичные конечные точки (7)
  • Time consumption of the course. [Срок оценки: During the procedure.]
  • Number of attempts. [Срок оценки: During the procedure.]
  • Successful endotracheal intubation. [Срок оценки: During the procedure.]
  • Overall course success. [Срок оценки: During the procedure.]
  • Severe oxygen desaturations [Срок оценки: During the procedure.]
  • Non-severe TIAEs [Срок оценки: 72 hours after the procedure]
  • Severe TIAEs [Срок оценки: 72 hours after the procedure]

Критерии участия

Patients are eligible if they adhere to all the following inclusion criteria:

● Undergoing video-directed oral or nasal endotracheal intubation.

Критерии исключения

Patients are excluded if they adhere to one of the exclusion criteria:

  • Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis).
  • Failed attempt by video laryngoscopy due to malfunctioning equipment.
  • Missing or corrupted video recording.
  • Informed consent is not obtained from the participants or participants' parents / legal guardians.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 2 центра
  • Rigshospitalet — Copenhagen
  • Capital Region of Denmark — Copenhagen

Идентификаторы

NCT: NCT05884645 · The DA-VITION study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗