Phenotype-Guided Weaning in Mechanically Ventilated Patients With Chronic Comorbidities

Официальное название

Effect of a Phenotype-Guided Precision Intervention Strategy on 28-Day Ventilator-Free Days in Mechanically Ventilated Patients With Chronic Comorbidities: A Multicenter Open-Label Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn whether a phenotype-guided weaning strategy can help adults with chronic comorbidities be liberated from invasive mechanical ventilation earlier. It will also learn about the safety of this strategy. The main questions it aims to answer are: * Does the phenotype-guided weaning strategy increase the number of ventilator-free days within 28 days after enrollment? * Does the strategy improve the process and success of ventilator liberation? * What safety events occur when this strategy is used? Researchers will compare the phenotype-guided weaning strategy with standard care in mechanically ventilated patients with chronic cardiovascular, cerebrovascular, or respiratory comorbidities. In the intervention period, participants will receive a protocolized ventilator weaning pathway. This pathway includes assisted ventilation transition, daily weaning readiness screening, a 0 cmH2O continuous positive airway pressure test, spontaneous breathing trial, extubation assessment, and post-extubation respiratory support when appropriate. The phenotype-guided part of the strategy is mainly used for participants who fail a spontaneous breathing trial or have difficult weaning. These participants will undergo structured ABCDE screening to identify the main phenotype or mechanism of weaning failure: * A: airway or lung dysfunction * B: brain dysfunction, including delirium, anxiety, agitation, or impaired consciousness * C: cardiac dysfunction * D: diaphragm or respiratory muscle dysfunction * E: endocrine, metabolic, or nutritional problems Based on the identified phenotype, clinicians will provide targeted assessment and treatment. Participants will be followed for ventilator-free days through day 28 and for clinical outcomes through day 90.

Вмешательства

• Другое Phenotype-Guided Weaning Strategy
  A protocolized phenotype-guided strategy for ventilator liberation. The pathway includes assisted ventilation transition, daily weaning readiness screening, a 0 cmH2O continuous positive airway pressure test, spontaneous breathing trial, extubation assessment, and post-extubation respiratory support when appropriate. The key phenotype-guided component is applied to participants with spontaneous breathing trial failure or difficult weaning. These participants undergo structured ABCDE screening to
• Другое Standard Care
  Usual mechanical ventilation and weaning management according to each center's routine clinical practice and current guidelines. The treating clinical team determines ventilator settings, weaning readiness assessment, spontaneous breathing trial, extubation assessment, post-extubation respiratory support, and related supportive care.

Первичные конечные точки

• Number of 28-Day Ventilator-Free Days [Срок оценки: From enrollment to day 28]

Вторичные конечные точки (3)

• Number of Participants With Intensive Care Unit or Hospital Mortality [Срок оценки: Day 28 and day 90 after enrollment]
• Time From Enrollment to Successful Weaning [Срок оценки: From enrollment to day 28]
• Number of Participants in Each Weaning Outcome Category [Срок оценки: From enrollment to day 28]

Критерии участия

Критерии включения

• Age 18 years or older.
• Presence of at least one chronic cardiovascular, cerebrovascular, or respiratory comorbidity. Cardiovascular and cerebrovascular comorbidities include stroke, hypertension, ischemic heart disease, valvular heart disease, heart failure, pulmonary heart disease, cardiomyopathy, and arrhythmia. Respiratory comorbidities include chronic obstructive pulmonary disease, asthma, bronchitis, emphysema, interstitial lung disease, and pneumoconiosis. These conditions will be identified according to the International Classification of Diseases 11th Revision diagnosis codes.
• Receiving invasive mechanical ventilation for at least 24 hours and expected to require mechanical ventilation for at least 72 hours.
• Not receiving neuromuscular blocking agents and having a Richmond Agitation-Sedation Scale score of -3 or higher.
• PaO2/FiO2 of 150 mmHg or higher.

Критерии исключения

• Severe neuromuscular disease, such as Guillain-Barre syndrome, myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, or high spinal cord injury.
• Severe dysfunction of other organs with expected death in the short term.
• Severe end-stage irreversible respiratory, cardiac, neurological, or malignant disease, or receiving palliative care.
• Pregnancy.
• Participation in another clinical study.
• Written informed consent not provided.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07594418 · Phenotype-Weaning-Chronic

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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