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Идёт набор NCT06561295

Optimal Timing for Spontaneous Breathing Trials

Без фазы С лечением Respiration, Artificial Weaning

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: Later Morning Timing of Spontaneous Breathing Trials.
Кому может быть актуально
Состояния в реестре: Respiration, Artificial, Weaning. Базовые параметры: от 21 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
США
Следующий шаг
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Официальное название

Impact of Spontaneous Breathing Trial Timing on Outcomes in Mechanically Ventilated Adult Patients

Обзор

This study aims to explore how the timing of Spontaneous Breathing Trials (SBTs) affects recovery in adult patients who are on mechanical ventilation in the ICU. SBTs are tests used to determine if a patient is ready to breathe on their own without the help of a ventilator. The study will compare two different timing strategies for these trials: one group of patients will have the test early in the morning, while the other group will have it later in the morning. By observing the outcomes, such as how long patients need to stay on the ventilator, the study hopes to find the best time to perform these trials to help patients recover more quickly and safely.

Подробное описание

This study seeks to understand how the timing of Spontaneous Breathing Trials (SBTs) impacts the recovery of adult patients who are on mechanical ventilation in the Intensive Care Unit (ICU). Mechanical ventilation is a life-support technique used for patients who are unable to breathe on their own. The Spontaneous Breathing Trial is a key step in assessing whether a patient is ready to breathe independently and can safely have the ventilator removed.

Currently, there is no universal standard for the best time of day to conduct these trials. Some hospitals perform SBTs early in the morning, while others wait until later in the morning when more staff are available. This study will compare two groups of patients: one group will have their SBTs early in the morning, and the other group will have them later.

The primary goal is to determine whether the timing of these trials affects how long patients need mechanical ventilation, how quickly they can be safely extubated (removal of the breathing tube), and overall recovery outcomes, such as ICU stay and hospital discharge.

Вмешательства

  • Другое Later Morning Timing of Spontaneous Breathing Trials
    Later Morning Group: Patients in this group will have their SBTs scheduled between 8:00 AM and 9:00 AM, closer to the time of day shift rounds.

Первичные конечные точки

  • mechanical ventilation duration [Срок оценки: From enrollment to the end of study at 28 days]
Вторичные конечные точки (5)
  • Duration Between SBT Success and Extubation [Срок оценки: From enrollment to the end of study at 28 days]
  • ICU and Hospital Mortality [Срок оценки: From enrollment to the end of study at 28 days]
  • ICU and Hospital Lengths of Stay [Срок оценки: From enrollment to the end of study at 28 days]
  • Reintubation Rates [Срок оценки: From enrollment to the end of study at 28 days]
  • Tracheostomy Rates [Срок оценки: From enrollment to the end of study at 28 days]

Критерии участия

Критерии включения

  • Adults aged 21 years or older.
  • Patients who have been on mechanical ventilation for more than 48 hours.
  • Patients who have completed at least one SBT.

Критерии исключения

  • Patients intubated at other hospitals.
  • Patients intubated for surgical or interventional procedures.
  • Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO).
  • Patients with a tracheostomy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Rush University Medical Center — Chicago

Публикации

  • Roberts KJ. 2022 Year in Review: Ventilator Liberation. Respir Care. 2023 Nov 25;68(12):1728-1735. doi: 10.4187/respcare.11114. PMID 37402584
  • Jung B, Vaschetto R, Jaber S. Ten tips to optimize weaning and extubation success in the critically ill. Intensive Care Med. 2020 Dec;46(12):2461-2463. doi: 10.1007/s00134-020-06300-2. Epub 2020 Oct 26. No abstract available. PMID 33104823
  • Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP. Liberation From Mechanical Ventilation in Critically Ill Adults: An Official American College of Chest Physicians/American Thoracic Society Clinical Practice Gui PMID 27818331
  • Roberts KJ, Goodfellow LT, Battey-Muse CM, Hoerr CA, Carreon ML, Sorg ME, Glogowski J, Girard TD, MacIntyre NR, Hess DR. AARC Clinical Practice Guideline: Spontaneous Breathing Trials for Liberation From Adult Mechanical Ventilation. Respir Care. 2024 Jun 28;69(7):891-901. doi: 10.4187/respcare.11735. PMID 38443142

Идентификаторы

NCT: NCT06561295 · 24081701

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗