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Набор скоро начнётся NCT07324460

One-Hour Positive Pressure Ventilation After a Pressure Support Spontaneous Breathing Trial

Без фазы С лечением Airway Extubation Weaning Mechanical Ventilation Extubation Failure

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: One-hour positive pressure ventilation, Immediate extubation.
Кому может быть актуально
Состояния в реестре: Airway Extubation, Weaning Mechanical Ventilation, Extubation Failure. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

One-Hour Positive Pressure Ventilation After a Pressure Support Spontaneous Breathing Trial: A Randomized Clinical Trial

Обзор

This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on pressure support. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions:1) One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated.2) Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.

Подробное описание

Adaptive design for sample size. The study will include up to a maximum of 4.000 patients. First interim analysis will be performed after complete data is available for the first 500 eligible patients. The Bayesian logistic regression model will be adjusted to provide posterior probabilities that will be compared with threshold values to evaluate stopping decisions. Extensive simulations were conducted to develop and understand adaptive design performance, interim analysis timing, and decision criteria. The trial may be stopped early for efficacy or futility. Secondary outcomes will be analyzed with a gatekeeping procedure to preserve overall type I error at 0.05. Thus, the assessment of statistical significance of secondary outcomes will be performed only if the preceding outcome in the hierarchy met the threshold for statistical significance. No adjustment for multiple comparisons will be applied for analyses of tertiary outcomes and subgroups. Thus, these results should be interpreted as exploratory.Secondary outcomes tested in hierarchical order will be: (1) Mechanical ventilation free days within 28 days; (2) Hospital free days within 28 days; (3) Mortality within 28 days.

Вмешательства

  • Другое One-hour positive pressure ventilation
    As soon as the success of the spontaneous breathing trial is confirmed, the patient will be submitted to one-hour positive pressure ventilation using the previous ventilatory parameters and, afterwards, extubated.
  • Другое Immediate extubation
    The patient will be extubated immediately (up to 10 minutes) after the success of the spontaneous breathing trial.

Первичные конечные точки

  • Number of Participants With Extubation Failure Within 7 Days [Срок оценки: 7 days (from randomization through Day 7 after randomization)]
Вторичные конечные точки (3)
  • Ventilator-Free Days Through Day 28 [Срок оценки: 28 days (from randomization through Day 28 after randomization)]
  • Hospital-Free Days Through Day 28 [Срок оценки: 28 days (from randomization through Day 28 after randomization)]
  • Number of Participants Who Died Within 28 Days [Срок оценки: 28 days (from randomization through Day 28 after randomization)]

Критерии участия

Критерии включения

  • Patients aged > 18 years.
  • Admitted to the intensive care unit (surgical or medical).
  • With endotracheal intubation.
  • Mechanical ventilation for more than 72 hours.
  • Who underwent successful spontaneous breathing trial (according to the study protocol) and is considered able to be extubated.

Критерии исключения

  • Patients unable to obey commands.
  • With non-planned extubation.
  • Neuromuscular disease and cervical spinal cord injury.
  • Tracheostomy.
  • Contraindication for cardiopulmonary resuscitation or reintubation.
  • Terminal extubation.
  • Lack of informed consent.
  • Previously included in the trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07324460 · GS-Wean: PSV SBT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗