Testing breathing support methods for patients on ventilators
Official title: A Cluster-Randomized Crossover Trial to Compare Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
Run by National Taiwan University Hospital · NCT04222205 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests two different ways to help patients on ventilators breathe on their own to see which method helps them get off the ventilator safely and more successfully.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 2143 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 3 sites (Taipei, Please Select and 2 other locations) |
| Trial ID | NCT04222205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults in the ICU who are receiving invasive mechanical ventilation and meet specific readiness criteria for a spontaneous breathing trial.
✕Probably not a fit
Patients who are under 20 years old, on do-not-intubate orders, or have been on mechanical ventilation for less than 12 hours may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates two methods for conducting spontaneous breathing trials (SBT) in patients who are being weaned off mechanical ventilation. The researchers will compare the effectiveness of T-piece breathing versus inspiratory pressure augmentation to determine which method leads to higher success rates in weaning patients from invasive mechanical ventilation. The goal is to identify patients ready for extubation without risking premature removal from the ventilator. The study aims to reduce the duration of mechanical ventilation and minimize the risk of reintubation.
Why it matters
Potential benefit: If successful, this study could improve the weaning process for mechanically ventilated patients, leading to faster recovery and reduced hospital stays.
How similar studies have gone: Previous studies have shown varying success with different SBT methods, but this specific comparison of inspiratory pressure augmentation versus T-piece is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Admitted to the adult intensive care unit (ICU) 2. Receiving invasive mechanical ventilation via an endotracheal tube 3. Ready to start an SBT\* \*The criteria of readiness to an SBT include FiO2 ≤ 0.4, PEEP ≤ 8 cmH2O, minute ventilation ≤ 0.15 L/min/predicted body weight, inspiratory pressure or driving pressure ≤ 14 cm H2O, stable cardiovascular status and no worsening of non-pulmonary organ function. Exclusion Criteria: 1. Age \< 20 years 2. Receiving mechanical ventilation via tracheostomy 3. Mechanical ventilation \< 12 hours 4. Invasive ventilation started before the index hospitalization 5. On do-not-intubate order
Where it's running
-
National Taiwan University Hospital
Taipei, Please Select, Taiwan Recruiting -
National Taiwan University Hospital Hsin-Chu Branch
Hsin-Chu, Taiwan Recruiting -
National Taiwan University Hospital Yunlin Branch
Yunlin, Taiwan Recruiting
Study contacts
- Study coordinator: Sheng-Yuan Ruan, MD, PhD
- Email: syruan@ntu.edu.tw
- Phone: 886223123456
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Shenfu Injection to help wean and reduce ventilator dependence in adults on mechanical ventilation
This trial tests whether Shenfu Injection, added to standard care, helps critically ill adults on invasive ventilation breathe without the machine sooner and reduces diaphragm dysfunction.
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Can a chest heart rhythm monitor help predict when ICU patients on a ventilator can breathe without the tube?
This study tests if a chest monitor that tracks heart rhythm can help predict when adults in the ICU on a ventilator will be able to breathe on their own after extubation.
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We are testing whether using a powered leg exoskeleton during training can improve leg strength, breathing measures, and recovery time for people who have been on a ventilator for a long period.
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Readiness for EXtubation (REXs) score for patients on invasive mechanical ventilation
This will test the Readiness for EXtubation (REXs) score to see if it can predict which ICU patients on invasive mechanical ventilation can be safely extubated.
-
Instrumental respiratory physiotherapy for patients struggling to wean off ventilators
This study tests if a new type of breathing therapy can help patients who have trouble getting off ventilators feel better and cough stronger than with regular therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.