Ventilator LungNCT06542107
Weaning From Mechanical Ventilation in Patients With Acute Brain Injury
An observational study of Ventilator Lung and Acute Brain Injury, run by Southeast University, China at 1 site in China.
Trial summary
Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Lung, Acute Brain Injury
- How many people
- 605 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 16 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All patients admitted to the ICU due to acute brain injury and treated with invasive mechanical ventilation
Who may be able to join
- acute brain injury
- age >=18 years
- invasive mechanical ventilation for at least 24 hours
Who cannot join
- tracheostomized before ICU admission
- pregnant or lactation
- with cervical spinal cord injury
- decision to receive palliative care within 24 hours of ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Weaning for Patients With Acute Brain Injury Undergoing Mechanical Ventilation
Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. However, the rate of extubation failure was significantly higher in ABI patients compared with non-neurological critical care patients. In patients who have failed one or several trials of extubation, tracheostomy is recommend according to the latest ESICM consensus. Tracheostomy can enhance comfort, improve pulmonary hygiene and decrease sedation requirement, which could facilitate the liberation from ventilator.
Numerous studies have explored the causes of weaning failure and provide various predictive models in guiding extubation and tracheostomy. Yet, due to limitations of such as small sample size or a lack of external validation, there is paucity of practical weaning algorithm tailored for ABI patients. The liberation from IMV in ABI patients still remains challenging with poor level of evidence in current guidelines or expert consensus.
We aim to describe the weaning outcomes in ABI patients, and further investigate the potential predictors of weaning success in ABI patients.
- Conditions
- Ventilator Lung, Acute Brain Injury
- Keywords
- mechanical ventilation, acute brain injury, weaning
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning success
successfully weaned from invasive ventilation according to WIND classification
Measured: up to 7-day period (ICU stay)
Secondary outcomes (1)
extubation
Extubation without the need for reintubation or death within a 7-day period, or upon ICU discharge, whichever occurs first
Measured: up to 7-day period (ICU stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start6 Aug 2024
- Primary completion31 Dec 2025
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator LungStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542107
- Sponsor's protocol ID
- WEAN ABI
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Weaning for Patients With Acute Brain Injury Undergoing Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06542107
- Acronym / sponsor ID
- WEAN ABI
- Conditions
- Ventilator Lung, Acute Brain Injury
- Keywords
- mechanical ventilation, acute brain injury, weaning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 7 Aug 2024 (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.
Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. However, the rate of extubation failure was significantly higher in ABI patients compared with non-neurological critical care patients. In patients who have failed one or several trials of extubation, tracheostomy is recommend according to the latest ESICM consensus. Tracheostomy can enhance comfort, improve pulmonary hygiene and decrease sedation requirement, which could facilitate the liberation from ventilator.
Numerous studies have explored the causes of weaning failure and provide various predictive models in guiding extubation and tracheostomy. Yet, due to limitations of such as small sample size or a lack of external validation, there is paucity of practical weaning algorithm tailored for ABI patients. The liberation from IMV in ABI patients still remains challenging with poor level of evidence in current guidelines or expert consensus.
We aim to describe the weaning outcomes in ABI patients, and further investigate the potential predictors of weaning success in ABI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICU due to acute brain injury and treated with invasive mechanical ventilation
Key inclusion criteria (3 listed)
- acute brain injury
- age >=18 years
- invasive mechanical ventilation for at least 24 hours
Key exclusion criteria (4 listed)
- tracheostomized before ICU admission
- pregnant or lactation
- with cervical spinal cord injury
- decision to receive palliative care within 24 hours of ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
weaning success
Time frame: up to 7-day period (ICU stay)
successfully weaned from invasive ventilation according to WIND classification
1 secondary outcome
extubation
Time frame: up to 7-day period (ICU stay)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Lung and Acute Brain Injury, run by Southeast University, China at 1 site in 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning success (time frame: up to 7-day period (ICU stay)). 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 9 Sep 2026.