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Идёт набор NCT06683781

Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients

— Наблюдательное Mechanical Ventilation Weaning Failure Weaning Failure of Mechanical Ventilation Intensive Care Unit ICU

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: Mechanical Ventilation, Weaning Failure, Weaning Failure of Mechanical Ventilation, Intensive Care Unit ICU. 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
Аргентина
Следующий шаг
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Официальное название

Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients: A Retrospective Study

Обзор

Mechanical ventilation (MV) is essential in managing acute respiratory failure. Its duration is a crucial aspect since both, unnecessary prolongation and premature withdrawal have deleterious effects on patient outcomes in the ICU. The process of weaning refers to the set of procedures and evaluations carried out to discontinue MV. Regardless of the definition used, within the population undergoing weaning, there is a group of patients who successfully pass the daily screening but fail the spontaneous breathing trial (SBT) or the separate attempt (SA). In Argentina, this figure is 39.5%, and 31.4% in patients with COVID-19. On the other hand, another group of patients successfully passes the SA, is extubated, but fails in post-extubation. This failure rate varies in the literature, ranging from approximately 10 to 20%. In our country, this figure is 16% in the general population and rises to 29.7% in COVID-19 patients. Additionally, this population is divided into those who cannot tolerate ventilation without an artificial airway due to upper airway patency issues (such as laryngeal edema), i.e., "airway failure," and those who experience acute respiratory failure. In 2023, the WEAN SAFE study reported novel findings regarding variables associated with weaning failure. In multivariable analysis, it was found that the MV settings and monitoring variables at the time of the first SBT - respiratory rate, positive end-expiratory pressure (PEEP), dynamic airway pressure difference (peak pressure (Ppeak) minus PEEP) on the day of the SA - were associated with weaning failure. In this context, the investigators will conduct a retrospective cohort study, whose primary objective will be to assess which MV settings and monitoring variables are associated with weaning failure. \*\*Primary Objective\*\* To determine if there are any MV settings or monitoring variables that are associated with extubation failure. \*\*Secondary Objective\*\* To determine if there are any MV settings or monitoring variables that are associated with failure in the first SBT.

Первичные конечные точки

  • Number of participants with extubation failure [Срок оценки: 7 days]
  • Cause of reintubation [Срок оценки: 7 days]
Вторичные конечные точки (1)
  • Spontaneous breathing trial failure [Срок оценки: Immediately after spontaneous breathing trial]

Критерии участия

Критерии включения

  • Over 18 years
  • MV for at least 48 hours, regardless of the cause of onset
  • Undergone at least one extubation, regardless of the outcome
  • At least one spontaneous breathing trial (SBT) during their ICU stay, regardless of the outcome

Критерии исключения

  • MV records containing incorrect or inconsistent data
  • did not have adequate or continuous monitoring during the weaning process

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Аргентина · 1 центр
  • Hospital Italiano de Buenos Aires — Buenos Aires

Публикации

  • Steinberg E, Garegnani LI, Steinberg D, Manias E, Lovazzano P, Mazzini L, Nieto J, Lavitola N, Gimenez ML, Setten M. Ventilator Settings and Monitoring Variables Associated with Extubation Failure in Critically Ill Patients: A Retrospective Cohort Study. Crit Care Sci. 2026 May 11;38:e20260327. doi: 10.62675/2965-2774.20260327. eCollection 2026. PMID 42138867

Идентификаторы

NCT: NCT06683781 · 7221

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗