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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenotype-Guided Weaning Strategy | Experimental | During the intervention period, participants receive standard intensive care plus a protocolized phenotype-guided weaning strategy. The strategy 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. For participants who fail a spontaneous breathing trial or have difficult weaning, structured ABCDE screening is used to identify the dominant phenotype of weaning failure, including airway or lung dysfunction, brain dysfunction, cardiac dysfunction, diaphragm or respiratory muscle dysfunction, and endocrine, metabolic, or nutritional problems. Targeted management is provided according to the identified phenotype. |
|
| Standard Care | Active Comparator | During the control period, participants receive usual mechanical ventilation and weaning management according to each center's routine clinical practice and current guidelines. Management may include ventilator mode and parameter adjustment, treatment of underlying disease and complications, analgesia and sedation, fluid and hemodynamic management, nutrition, early mobilization and rehabilitation, airway management, weaning readiness assessment, spontaneous breathing trial, extubation assessment, and post-extubation respiratory support as determined by the treating clinical team. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenotype-Guided Weaning Strategy | Other | 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 identify the dominant mechanism of weaning failure: A, airway or lung dysfunction; B, brain dysfunction; C, cardiac dysfunction; D, diaphragm or respiratory muscle dysfunction; and E, endocrine, metabolic, or nutritional problems. Targeted evaluation and treatment are then provided according to the identified phenotype. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of 28-Day Ventilator-Free Days | Ventilator-free days are defined as the number of days within 28 days after enrollment during which the participant is alive and free from invasive mechanical ventilation for at least 24 consecutive hours. Participants who die before day 28 or who remain mechanically ventilated at day 28 will be assigned zero ventilator-free days. | From enrollment to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intensive Care Unit or Hospital Mortality | Intensive care unit mortality and hospital mortality will be assessed at day 28 and day 90 after enrollment. | Day 28 and day 90 after enrollment |
| Time From Enrollment to Successful Weaning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Li, MD | Contact | +8615651782917 | liyangseu@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Ling Liu, phD | Zhongda Hospital, School of Medicine, Southeast University | Principal Investigator |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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This is a stepped-wedge cluster randomized trial. Intensive care units are randomized as clusters. All clusters start in the standard care period and then sequentially cross over to the phenotype-guided weaning intervention according to a pre-specified randomized sequence. Individual participants do not cross over between study conditions.
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| Standard Care | Other | 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. |
|
Time from enrollment to successful weaning. For intubated participants, successful weaning is defined as no death or reintubation within 7 days after extubation, or discharge from the intensive care unit within 7 days without invasive mechanical ventilation, whichever occurs first. For tracheostomized participants, successful weaning is defined as 7 consecutive days of spontaneous breathing through the tracheostomy without any mechanical ventilation, or discharge while breathing spontaneously, whichever occurs first. |
| From enrollment to day 28 |
| Number of Participants in Each Weaning Outcome Category | Participants will be classified into weaning outcome categories, including successful weaning, no weaning attempt, short weaning, difficult weaning, prolonged weaning success, and prolonged weaning failure. | From enrollment to day 28 |