Mechanical Ventilation WeaningNCT07594418
Phenotype-Guided Weaning in Mechanically Ventilated Patients With Chronic Comorbidities
A study testing Phenotype-Guided Weaning Strategy in people with Mechanical Ventilation Weaning and Chronic Disease, run by Southeast University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Weaning, Chronic Disease
- What is being tested?
- Phenotype-Guided Weaning Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,380 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- Mechanical Ventilation Weaning, Chronic Disease
- Being tested
- Phenotype-Guided Weaning Strategy, Standard Care
- Keywords
- Phenotype-Guided Weaning, Ventilator Liberation, Ventilator-Free Days, Chronic Comorbidities, Spontaneous Breathing Trial, ABCDE Screening
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotype-Guided Weaning StrategyOther
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.
Standard CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Phenotype-Guided Weaning Strategy |
| 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to day 28
Secondary outcomes (3)
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.
Measured: Day 28 and day 90 after enrollment
Time From Enrollment to Successful Weaning
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.
Measured: 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.
Measured: From enrollment to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 1,380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Ling Liu, phD, Principal investigator, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594418
- Sponsor's protocol ID
- Phenotype-Weaning-Chronic
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07594418
- Acronym / sponsor ID
- Phenotype-Weaning-Chronic
- Conditions
- Mechanical Ventilation Weaning, Chronic Disease
- Keywords
- Phenotype-Guided Weaning, Ventilator Liberation, Ventilator-Free Days, Chronic Comorbidities, Spontaneous Breathing Trial, ABCDE Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,380 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phenotype-Guided Weaning Strategy | Experimental | Other: Phenotype-Guided Weaning StrategyDuring 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 | Other: Standard CareDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenotype-Guided Weaning StrategyA 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. | Other | Phenotype-Guided Weaning Strategy |
| Standard CareUsual 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. | Other | Standard Care |
Primary outcome
Number of 28-Day Ventilator-Free Days
Time frame: 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.
3 secondary outcomes
Number of Participants With Intensive Care Unit or Hospital Mortality
Time frame: Day 28 and day 90 after enrollment
Time From Enrollment to Successful Weaning
Time frame: From enrollment to day 28
Number of Participants in Each Weaning Outcome Category
Time frame: From enrollment to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ling Liu, phD principal investigator
Zhongda Hospital, School of Medicine, Southeast University
Questions about this trial
What is this clinical trial studying?
A study testing Phenotype-Guided Weaning Strategy in people with Mechanical Ventilation Weaning and Chronic Disease, run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Li, MD (+8615651782917, liyangseu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 28-Day Ventilator-Free Days (time frame: From enrollment to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.