Ventilator WeaningSBT-TIPNCT04222205
Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
A study testing Spontaneous breathing trial (SBT) crossover sequence 1 and Spontaneous breathing trial (SBT) crossover sequence 2 in people with Ventilator Weaning, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial summary
Weaning is an important process to gradually separate mechanically ventilated patients from ventilators. A good weaning strategy aims to early identify mechanically ventilated patients who are ready for extubation but not to prematurely extubate them. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- Spontaneous breathing trial (SBT) crossover sequence 1 and Spontaneous breathing trial (SBT) crossover sequence 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,143 participants
- Where
- 3 sitesTaiwan
- Study dates
- 1 Dec 2019to 30 Jun 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the adult intensive care unit (ICU)
- Receiving invasive mechanical ventilation via an endotracheal tube
- 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.
Who cannot join
- Age < 20 years
- Receiving mechanical ventilation via tracheostomy
- Mechanical ventilation < 12 hours
- Invasive ventilation started before the index hospitalization
- On do-not-intubate order
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu
National Taiwan University Hospital
Taipei, Please Select, 10002
National Taiwan University Hospital Yunlin Branch
Yunlin, 63247
About this study
Official title: A Cluster-Randomized Crossover Trial to Compare Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
Weaning is an important process to gradually separate mechanically ventilated patients from ventilators. A good weaning strategy aims to early identify mechanically ventilated patients who are ready for extubation but not to prematurely extubate them. Spontaneous breathing trial (SBT) is a test to assess the patient's ability to breathe spontaneously when extubated. Several methods have been used to conduct an SBT, including T-piece breathing, low-level pressure support ventilation (PSV) of 5-7 cm H2O, continuous positive airway pressure and automatic tube compensation (ATC).
The investigators hypothesized that an SBT with inspiratory pressure augmentation increases initial SBT success, reduces the length of invasive mechanical ventilation (iMV) support and does not increase reintubation risk as compared with T-piece, which result in a higher proportion of patients successfully liberated from iMV in the inspiratory pressure augmentation group. However, inspiratory pressure augmentation significantly reduces work of breathing on an SBT as compared with T-piece. Patients extubated following an SBT with inspiratory pressure augmentation may experience increased respiratory effort after extubation and this may increase the use of noninvasive ventilation after extubation. An SBT with inspiratory pressure augmentation increases iMV free days but not MV free days as compared with T-piece. Longer iMV free days may be associated with a lower mortality due to fewer iMV related complication.
This study is a pragmatic, cluster-randomized, multiple crossover, multicenter trial to compare SBTs with T-piece versus inspiratory pressure augmentation in weaning outcomes. Mechanically ventilated patients who meet the criteria for readiness to SBT will be included. The patients will use either T-piece or inspiratory pressure augmentation as SBT for weaning according to an ICU-based cluster randomization and crossover sequence.
- Conditions
- Ventilator Weaning
- Being tested
- Spontaneous breathing trial (SBT) crossover sequence 1, Spontaneous breathing trial (SBT) crossover sequence 2
- Keywords
- Clinical trial, Mechanical ventilation, Respiratory failure, Spontaneous breathing trial, Weaning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous breathing trial (SBT) crossover sequence 1Diagnostic test
SBTs with T-piece breathing for one hour during odd-numbered months and SBTs with inspiratory pressure augmentation for one hour during even-numbered months.
Spontaneous breathing trial (SBT) crossover sequence 2Diagnostic test
SBTs with inspiratory pressure augmentation for one hour during odd-numbered months and SBTs with T-piece breathing for one hour during even-numbered months.
| Study group | Role | What they receive |
|---|---|---|
| Crossover sequence 1 | Active comparator | Cluster-randomization crossover sequence 1:
T-piece during odd-numbered months and inspiratory pressure augmentation during even-numbered months. Receives: Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 1 |
| Crossover sequence 2 | Experimental | Cluster-randomization crossover sequence 2:
T-piece during even-numbered months and inspiratory pressure augmentation during odd-numbered months. Receives: Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful liberation from invasive mechanical ventilation
The primary study endpoint is to compare the effect of SBT with T-piece versus inspiratory pressure augmentation on the proportion of patients with successful liberation from invasive mechanical ventilation in the ICU among patients who have started an SBT. Successful liberation is defined as sustaining iMV free for at least five days after extubation.
Measured: ICU discharge, up to 28 days after the initial SBT
Secondary outcomes (12)
Successful liberation from invasive and noninvasive mechanical ventilation
Proportion of successful liberation from invasive and noninvasive mechanical ventilation in the ICU.
Measured: ICU discharge, up to 28 days after the initial SBT
Successful liberation from invasive mechanical ventilation
Proportion of successful liberation from invasive mechanical ventilation on day 28 from intubation.
Measured: 28 days
Time to successful liberation from invasive mechanical ventilation
Time to successful liberation from invasive mechanical ventilation using competing-risks analysis.
Measured: 28 days
Time to successful liberation from invasive and noninvasive mechanical ventilation
Time to successful liberation from invasive and noninvasive mechanical ventilation using competing-risks analysis.
Measured: 28 days
Intubation free days
The number of days that a patient is alive and free from intubation.
Measured: 28 days
Adjusted risk ratio of successful liberation from invasive mechanical ventilation
Adjusted risk ratio of successful liberation from invasive mechanical ventilation for T-piece versus inspiratory pressure augmentation group.
Measured: ICU discharge, up to 28 days after the initial SBT
Initial SBT success
Proportion of initial SBT success among patients who have started an SBT.
Measured: During the ICU stay, up to 28 days
Extubation failure
Proportion of extubation failure among patients undergoing planned extubation.
Measured: Five days from extubation
Proportion of planned extubation
Proportion of planned extubation in the ICU
Measured: ICU discharge, up to 28 days after the initial SBT
Use of noninvasive ventilation after extubation
Proportion of use of noninvasive ventilation (>24 hours) after extubation.
Measured: Five days from extubation
ICU mortality
Proportion of death in the ICU.
Measured: ICU discharge, up to 28 days after the initial SBT
28-day mortality
Probability of death in 28 days using kaplan-meier estimator.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Dec 2019
- Primary completion29 Dec 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster-Randomized Crossover Trial
- Masking
- None (open label)
- Enrolment
- 2,143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Fu-Chang Tsai, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222205
- Sponsor's protocol ID
- 201901036RINA
- Acronym
- SBT-TIP
- Status last verified
- Jun 2025
- First submitted
- 8 Dec 2019
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-Randomized Crossover Trial to Compare Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
- ClinicalTrials.gov ID
- NCT04222205
- Acronym / sponsor ID
- SBT-TIP / 201901036RINA
- Conditions
- Ventilator Weaning
- Keywords
- Clinical trial, Mechanical ventilation, Respiratory failure, Spontaneous breathing trial, Weaning
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,143 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Jan 2020 (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.
Weaning is an important process to gradually separate mechanically ventilated patients from ventilators. A good weaning strategy aims to early identify mechanically ventilated patients who are ready for extubation but not to prematurely extubate them. Spontaneous breathing trial (SBT) is a test to assess the patient's ability to breathe spontaneously when extubated. Several methods have been used to conduct an SBT, including T-piece breathing, low-level pressure support ventilation (PSV) of 5-7 cm H2O, continuous positive airway pressure and automatic tube compensation (ATC).
The investigators hypothesized that an SBT with inspiratory pressure augmentation increases initial SBT success, reduces the length of invasive mechanical ventilation (iMV) support and does not increase reintubation risk as compared with T-piece, which result in a higher proportion of patients successfully liberated from iMV in the inspiratory pressure augmentation group. However, inspiratory pressure augmentation significantly reduces work of breathing on an SBT as compared with T-piece. Patients extubated following an SBT with inspiratory pressure augmentation may experience increased respiratory effort after extubation and this may increase the use of noninvasive ventilation after extubation. An SBT with inspiratory pressure augmentation increases iMV free days but not MV free days as compared with T-piece. Longer iMV free days may be associated with a lower mortality due to fewer iMV related complication.
This study is a pragmatic, cluster-randomized, multiple crossover, multicenter trial to compare SBTs with T-piece versus inspiratory pressure augmentation in weaning outcomes. Mechanically ventilated patients who meet the criteria for readiness to SBT will be included. The patients will use either T-piece or inspiratory pressure augmentation as SBT for weaning according to an ICU-based cluster randomization and crossover sequence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-Randomized Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| Crossover sequence 1 | Active comparator | Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 1Cluster-randomization crossover sequence 1: T-piece during odd-numbered months and inspiratory pressure augmentation during even-numbered months. |
| Crossover sequence 2 | Experimental | Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 2Cluster-randomization crossover sequence 2: T-piece during even-numbered months and inspiratory pressure augmentation during odd-numbered months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the adult intensive care unit (ICU)
- Receiving invasive mechanical ventilation via an endotracheal tube
- 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.
Key exclusion criteria (5 listed)
- Age < 20 years
- Receiving mechanical ventilation via tracheostomy
- Mechanical ventilation < 12 hours
- Invasive ventilation started before the index hospitalization
- On do-not-intubate order
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 |
|---|---|---|
| Spontaneous breathing trial (SBT) crossover sequence 1SBTs with T-piece breathing for one hour during odd-numbered months and SBTs with inspiratory pressure augmentation for one hour during even-numbered months. | Diagnostic test | Crossover sequence 1 |
| Spontaneous breathing trial (SBT) crossover sequence 2SBTs with inspiratory pressure augmentation for one hour during odd-numbered months and SBTs with T-piece breathing for one hour during even-numbered months. | Diagnostic test | Crossover sequence 2 |
Primary outcome
Successful liberation from invasive mechanical ventilation
Time frame: ICU discharge, up to 28 days after the initial SBT
The primary study endpoint is to compare the effect of SBT with T-piece versus inspiratory pressure augmentation on the proportion of patients with successful liberation from invasive mechanical ventilation in the ICU among patients who have started an SBT. Successful liberation is defined as sustaining iMV free for at least five days after extubation.
12 secondary outcomes
Successful liberation from invasive and noninvasive mechanical ventilation
Time frame: ICU discharge, up to 28 days after the initial SBT
Successful liberation from invasive mechanical ventilation
Time frame: 28 days
Time to successful liberation from invasive mechanical ventilation
Time frame: 28 days
Time to successful liberation from invasive and noninvasive mechanical ventilation
Time frame: 28 days
Intubation free days
Time frame: 28 days
Adjusted risk ratio of successful liberation from invasive mechanical ventilation
Time frame: ICU discharge, up to 28 days after the initial SBT
Initial SBT success
Time frame: During the ICU stay, up to 28 days
Extubation failure
Time frame: Five days from extubation
Proportion of planned extubation
Time frame: ICU discharge, up to 28 days after the initial SBT
Use of noninvasive ventilation after extubation
Time frame: Five days from extubation
ICU mortality
Time frame: ICU discharge, up to 28 days after the initial SBT
28-day mortality
Time frame: 28 days
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 10 Jun 2025.
- Individual participant dataSharing planned: Undecided. The individual participant data are available from the corresponding author on reasonable request.
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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.
Daniel Fu-Chang Tsai, MD, PhD study chair
National Taiwan University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spontaneous breathing trial (SBT) crossover sequence 1 and Spontaneous breathing trial (SBT) crossover sequence 2 in people with Ventilator Weaning, run by National Taiwan University Hospital at 3 sites in Taiwan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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?
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?
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?
Successful liberation from invasive mechanical ventilation (time frame: ICU discharge, up to 28 days after the initial SBT). 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 10 Jun 2025.