Weaning adults with acute brain injury from mechanical ventilators
Prediction of Weaning for Patients With Acute Brain Injury Undergoing Mechanical Ventilation
This observational project will follow adults with acute brain injury who are on breathing machines to try to find practical ways to safely remove the ventilator and decide when a tracheostomy is needed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 406 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Southeast University, China Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06542107 on ClinicalTrials.gov |
What this trial studies
Patients with acute brain injury often require intubation and have higher rates of failed extubation than other ICU patients. This observational study at Zhongda Hospital will enroll adults with acute brain injury who have been on invasive mechanical ventilation for at least 24 hours and will collect clinical data on spontaneous breathing trials, extubation attempts, extubation failures, timing and use of tracheostomy, ventilation duration, and outcomes. No experimental treatments are given; investigators will analyze routinely collected clinical data to develop or validate weaning predictors and an algorithm tailored to ABI patients. The study aims to address limitations of prior work such as small sample sizes and lack of external validation.
Who should consider this trial
Good fit: Adults (≥18 years) with acute brain injury who have been receiving invasive mechanical ventilation for at least 24 hours and who were not tracheostomized before ICU admission, are not pregnant or lactating, have no cervical spinal cord injury, and are not expected to receive palliative care within 24 hours are ideal candidates.
Not a fit: Patients without acute brain injury, those not on invasive mechanical ventilation, those tracheostomized before ICU admission, with cervical spinal cord injury, who are pregnant or lactating, or who enter imminent palliative care are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could reduce failed extubations, lower unnecessary tracheostomies, shorten time on ventilators, and improve recovery for patients with acute brain injury.
How similar studies have performed: Previous research has explored causes of weaning failure and produced predictive models, but many studies were small or lacked external validation, so ABI-specific algorithms remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * acute brain injury * age \>=18 years * invasive mechanical ventilation for at least 24 hours Exclusion Criteria: * tracheostomized before ICU admission * pregnant or lactation * with cervical spinal cord injury * decision to receive palliative care within 24 hours of ICU admission
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Ling Liu — Nanjing, Jiangsu, China (Recruiting)
- Department of Critical Care Medicine, Zhongda Hospital — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: Ling Liu, PHD
- Email: liulingdoctor@126.com
- Phone: 86+83262553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.