Testing breathing support methods for patients on ventilators
A Cluster-Randomized Crossover Trial to Compare Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
NA · National Taiwan University Hospital · NCT04222205
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2143 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 3 sites (Taipei, Please Select and 2 other locations) |
| Trial ID | NCT04222205 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown varying success with different SBT methods, but this specific comparison of inspiratory pressure augmentation versus T-piece is relatively novel.
Eligibility criteria
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 this trial is running
Taipei, Please Select and 2 other locations
- 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
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.
Conditions: Ventilator Weaning, Clinical trial, Mechanical ventilation, Respiratory failure, Spontaneous breathing trial, Weaning