[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637731":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":24,"responsibleParty":39,"collaborators":24,"id":42,"slug":24,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":24,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":24,"enrollmentInfo":50,"targetDuration":24,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":67,"whyStopped":24,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":24},{"fullName":5,"class":6},"Southeast University, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Phenotype-Guided Weaning Strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Standard Care",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"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.",[15],[29],{"name":30,"affiliation":31,"role":32},"Ling Liu, phD","Zhongda Hospital, School of Medicine, Southeast University","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Yang Li, MD","CONTACT","+8615651782917","liyangseu@yeah.net",{"type":32,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Ling Liu","Professor, Department of Critical Care Medicine; Principal Investigator","100637731",false,"NCT07594418","Phenotype-Guided Weaning in Mechanically Ventilated Patients With Chronic Comorbidities","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","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. 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.\n3. Receiving invasive mechanical ventilation for at least 24 hours and expected to require mechanical ventilation for at least 72 hours.\n4. Not receiving neuromuscular blocking agents and having a Richmond Agitation-Sedation Scale score of -3 or higher.\n5. PaO2\u002FFiO2 of 150 mmHg or higher.\n\nExclusion Criteria:\n\n1. Severe neuromuscular disease, such as Guillain-Barre syndrome, myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, or high spinal cord injury.\n2. Severe dysfunction of other organs with expected death in the short term.\n3. Severe end-stage irreversible respiratory, cardiac, neurological, or malignant disease, or receiving palliative care.\n4. Pregnancy.\n5. Participation in another clinical study.\n6. Written informed consent not provided.","ALL","18 Years",{"count":51,"type":52},1380,"ESTIMATED","INTERVENTIONAL",[55],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Does the phenotype-guided weaning strategy increase the number of ventilator-free days within 28 days after enrollment?\n* Does the strategy improve the process and success of ventilator liberation?\n* What safety events occur when this strategy is used?\n\nResearchers will compare the phenotype-guided weaning strategy with standard care in mechanically ventilated patients with chronic cardiovascular, cerebrovascular, or respiratory comorbidities.\n\nIn 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.\n\nThe 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:\n\n* A: airway or lung dysfunction\n* B: brain dysfunction, including delirium, anxiety, agitation, or impaired consciousness\n* C: cardiac dysfunction\n* D: diaphragm or respiratory muscle dysfunction\n* E: endocrine, metabolic, or nutritional problems\n\nBased 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.",[58,59],"Mechanical Ventilation Weaning","Chronic Disease",[61,62,63,64,65,66],"Phenotype-Guided Weaning","Ventilator Liberation","Ventilator-Free Days","Chronic Comorbidities","Spontaneous Breathing Trial","ABCDE Screening","NOT_YET_RECRUITING","2026-05-17",{"date":70,"type":71},"2026-05-19","ACTUAL",{"date":73,"type":52},"2026-09",{"date":75,"type":52},"2027-11",{"name":5,"class":6}]