Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis

Официальное название

Effect of Bedside Flexible Bronchoscopy-Guided Airway Clearance on Lung Aeration in Mechanically Ventilated Patients With Atelectasis: A Multicenter Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn whether bedside flexible bronchoscopy-guided airway clearance can improve lung aeration in adult patients who are receiving invasive mechanical ventilation and have atelectasis with a high airway secretion burden. The main questions it aims to answer are: Does bedside flexible bronchoscopy-guided airway clearance reduce the proportion of nonaerated lung tissue from baseline to day 5? Does this treatment improve other lung aeration measures, respiratory mechanics, arterial blood gas parameters, pulmonary infection score, ventilator-free days, intensive care unit length of stay, and safety outcomes? Researchers will compare usual airway care plus bedside flexible bronchoscopy-guided airway clearance with usual airway care alone to see if bronchoscopy-guided airway clearance improves lung aeration and clinical outcomes. Participants will be randomly assigned to one of two groups. Participants in the usual care group will receive standard airway management, which may include airway suctioning, postural drainage, humidification, chest physiotherapy, and other routine respiratory care. Participants in the bronchoscopy group will receive the same usual care, plus bedside flexible bronchoscopy-guided airway clearance when predefined criteria for high airway secretion burden are met. Participants will have clinical assessments during the study, including chest imaging, respiratory mechanics measurements, arterial blood gas tests, pulmonary infection score assessment, and safety monitoring. The main assessment will compare quantitative chest computed tomography findings at baseline and day 5 to evaluate changes in nonaerated lung tissue.

Вмешательства

• Процедура Flexible Bronchoscopy-Guided Airway Clearance
  Bedside flexible bronchoscopy-guided airway clearance will be performed through the artificial airway in mechanically ventilated participants. The procedure will be used to inspect the tracheobronchial tree and remove retained airway secretions or mucus plugs by targeted suctioning. Small-volume saline lavage may be used when secretions are thick or difficult to remove. The intervention will be performed in addition to usual airway care when predefined criteria for high airway secretion burden a
• Другое Usual Airway Care
  Usual airway care may include airway suctioning, postural drainage, chest physiotherapy, mechanical airway clearance techniques, humidification and heating of inhaled gas, cuff pressure monitoring, and timely clearance of airway secretions according to routine clinical practice.

Первичные конечные точки

• Percent Change in CT-assessed Nonaerated Lung Percentage From Baseline to Day 5 [Срок оценки: Baseline to Day 5]

Вторичные конечные точки (8)

• Percent Change in CT-assessed Normally Aerated Lung Percentage From Baseline to Day 5 [Срок оценки: Baseline to Day 5, with chest CT performed within 24 hours of each time point]
• Change in static respiratory system compliance from baseline to Day 5 [Срок оценки: Baseline to Day 5]
• Change in driving pressure from baseline to Day 5 [Срок оценки: Baseline and Day 5]
• Change in plateau pressure from baseline to Day 5 [Срок оценки: Baseline and Day 5]
• Change in PaO2/FiO2 ratio from baseline to Day 5 [Срок оценки: Baseline and Day 5]
• Ventilator-free days within 28 days after randomization [Срок оценки: From randomization to Day 28]
• All-cause mortality within 28 days after randomization [Срок оценки: From randomization to Day 28]
• Length of stay in the intensive care unit [Срок оценки: From randomization to ICU discharge or death, assessed up to 28 days]

Критерии участия

Критерии включения

• Age 18 years or older
• Receiving invasive mechanical ventilation for at least 48 hours
• Presence of atelectasis confirmed by chest computed tomography, chest X-ray, or lung ultrasound
• High airway secretion burden, defined as requiring airway suctioning at least twice per hour during the previous 8 hours
• Written informed consent obtained from the participant or legally authorized representative

Критерии исключения

• Expected duration of artificial airway maintenance less than 5 days
• Untreated tension pneumothorax Known or suspected aspiration
• Active intrapulmonary hemorrhage
• Severe dysfunction of other organs with expected short-term mortality within 7 days or need for palliative care
• Any other condition judged by the medical team to make the participant unsuitable for the study
• Informed consent not obtained

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07594379 · BRONCO-CLEAR Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗