Chronic Disease, Mechanical Ventilation Weaning
Conditions
Keywords
Phenotype-Guided Weaning, Ventilator Liberation, Ventilator-Free Days, Chronic Comorbidities, Spontaneous Breathing Trial, ABCDE Screening
Brief summary
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.
Interventions
OTHERPhenotype-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 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.
OTHERStandard 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.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older. 2. 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. 3. Receiving invasive mechanical ventilation for at least 24 hours and expected to require mechanical ventilation for at least 72 hours. 4. Not receiving neuromuscular blocking agents and having a Richmond Agitation-Sedation Scale score of -3 or higher. 5. PaO2/FiO2 of 150 mmHg or higher.
Exclusion criteria
1. Severe neuromuscular disease, such as Guillain-Barre syndrome, myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, or high spinal cord injury. 2. Severe dysfunction of other organs with expected death in the short term. 3. Severe end-stage irreversible respiratory, cardiac, neurological, or malignant disease, or receiving palliative care. 4. Pregnancy. 5. Participation in another clinical study. 6. Written informed consent not provided.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of 28-Day Ventilator-Free Days | From enrollment to day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intensive Care Unit or Hospital Mortality | Day 28 and day 90 after enrollment | Intensive care unit mortality and hospital mortality will be assessed at day 28 and day 90 after enrollment. |
| Time From Enrollment to Successful Weaning | From enrollment to day 28 | 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. |
| Number of Participants in Each Weaning Outcome Category | From enrollment to day 28 | 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. |
Contacts
CONTACTYang Li, MD
PRINCIPAL_INVESTIGATORLing Liu, phD
Zhongda Hospital, School of Medicine, Southeast University
Outcome results
None listed