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Набор скоро начнётся NCT07198425

Predicting Success of Decannulation Using Wearable-derived Physiology

— Наблюдательное Tracheostomy Decannulation Physiological Parameter

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: Successful decannulation group, Failed decannulation group.
Кому может быть актуально
Состояния в реестре: Tracheostomy Decannulation, Physiological Parameter. Базовые параметры: 18 лет — 90 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

Predicting Success of Decannulation Using Wearable-derived Physiology : A Prospective Cohort Study

Обзор

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping. Each enrolled patient received physiological monitoring upon admission and the day prior to the initial use of the speaking valve, with continuous monitoring for 24 hours through wearable devices.The monitored physiological parameters were compared between the successful decannulation group and the failed decannulation group, and a predictive decannulation model was established in advance based on clinical parameters. Decannulation criteria: If the patient can tolerate wearing the speaking valve continuously for 4 hours (gradually increasing the duration: 30 minutes, 1 hour, 2 hours, 4 hours), and if PEF \> 100 liters/min, planned removal of the tracheostomy tube can be considered. Based on decannulation outcomes, patients were categorized into the successful decannulation group and the failed decannulation group. Successful decannulation group: Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulation. Failed decannulation group: Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.

Вмешательства

  • Другое Successful decannulation group
    Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulbation.
  • Другое Failed decannulation group
    Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.

Первичные конечные точки

  • Difference in physiological parameters between patients in the decannulation success and decannulation failure groups [Срок оценки: Monitor for 24 hours on the day of patient admission. During the 24 hours before wearing the speaking valve on the day of entering the decannulation process]

Критерии участия

Критерии включения

  • 18 years ≤ Age ≤ 90 years, non-mechanically ventilated patients.
  • Tracheotomy completed, ≥48 hours since cannula placement (postoperative early edema has stabilized).
  • Patient or legal representative has provided informed consent.

Критерии исключения

  • Recent (≤48 hours) major neck/upper airway surgery requiring avoidance of upper airway airflow impact.
  • Severe consciousness disorder/delirium (RASS ≤ -3 or ≥ +2), extreme anxiety/inability to cooperate.
  • Total laryngectomy or laryngo-tracheal separation.
  • Oral endotracheal intubation.
  • Age <18 years, Age > 90years.
  • Malignant tumor with an expected survival time ≤ 6 months.
  • Patients or legal representatives unable to obtain informed consent.
  • Known contraindications for tracheotomy decannulation.
  • Unable to comply with the use of wearable devices

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07198425 · 2026bkky-052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗