Airway ExtubationGS-Wean TpieceNCT07324382
One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial
A study testing One-hour positive pressure ventilation and Immediate extubation in people with Airway Extubation and Extubation Failure, run by Hospital do Coracao.
Trial summary
This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Extubation, Extubation Failure, Weaning Mechanical Ventilation
- What is being tested?
- One-hour positive pressure ventilation and Immediate extubation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Feb 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged > 18 years.
- Admitted to the intensive care unit (surgical or medical).
- With endotracheal intubation.
- Mechanical ventilation for more than 72 hours.
- Who underwent successful spontaneous breathing trial (according to the study protocol) and is considered able to be extubated.
Who cannot join
- Patients unable to obey commands.
- With non-planned extubation.
- Neuromuscular disease and cervical spinal cord injury.
- Tracheostomy.
- Contraindication for cardiopulmonary resuscitation or reintubation.
- Terminal extubation.
- Lack of informed consent.
- Previously included in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial: A Randomized Clinical Trial
This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on T-piece. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions:
- One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated.
- Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.
Read the detailed description
Adaptive design for sample size. The study will include up to a maximum of 4.000 patients. First interim analysis will be performed after complete data is available for the first 500 eligible patients. The Bayesian logistic regression model will be adjusted to provide posterior probabilities that will be compared with threshold values to evaluate stopping decisions. Extensive simulations were conducted to develop and understand adaptive design performance, interim analysis timing, and decision criteria. The trial may be stopped early for efficacy or futility. Secondary outcomes will be analyzed with a gatekeeping procedure to preserve overall type I error at 0.05. Thus, the assessment of statistical significance of secondary outcomes will be performed only if the preceding outcome in the hierarchy met the threshold for statistical significance. No adjustment for multiple comparisons will be applied for analyses of tertiary outcomes and subgroups. Thus, these results should be interpreted as exploratory. Secondary outcomes tested in hierarchical order will be: (1) Mechanical ventilation free days within 28 days; (2) Hospital free days within 28 days; (3) Mortality within 28 days.
- Being tested
- One-hour positive pressure ventilation, Immediate extubation
- Keywords
- Airway extubation, Extubation failure, Weaning Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-hour positive pressure ventilationOther
As soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated.
Immediate extubationOther
The patient is extubated immediately after the success of the spontaneous breathing trial.
| Study group | Role | What they receive |
|---|---|---|
| One-hour positive pressure ventilation | Experimental | Not described Receives: Other: One-hour positive pressure ventilation |
| Immediate extubation | Active comparator | Not described Receives: Other: Immediate extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Extubation Failure Within 7 Days
Extubation failure is defined as a composite endpoint of reintubation or death within 7 days after randomization.
Measured: 7 days (from randomization through Day 7 after randomization)
Secondary outcomes (3)
Ventilator-Free Days Through Day 28
Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation from randomization through Day 28 after randomization. If a patient dies before day 28, the ventilator-free days will be counted as zero. If a patient is reintubated and returns to mechanical ventilation and later is extubated again and remains in unassisted breathing until day 28, the ventilator-free days will be counted from the end of the last period of assisted breathing until day 28. An invasive mechanical ventilation period of less than 24 hours for surgical purposes will count as 1 ventilator-free day. Patients discharged from the hospital in unassisted breathing before 28 days will be considered alive and free from mechanical ventilation for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed up until day 28 to assess this outcome.
Measured: 28 days (from randomization through Day 28 after randomization)
Hospital-Free Days Through Day 28
Hospital-free days are defined as the number of days alive and out of the hospital from randomization through Day 28 after randomization. If a patient dies before day 28, the hospital-free days will be counted as zero. Patients discharged from the hospital in unassisted breathing before 28 days will be considered alive and free from hospital for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed through day 28 to ascertain this outcome.
Measured: 28 days (from randomization through Day 28 after randomization)
Number of Participants Who Died Within 28 Days
All-cause mortality from randomization through day 28
Measured: 28 days (from randomization through Day 28 after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ExtubationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324382
- Sponsor's protocol ID
- GS-Wean: T-piece SBT
- Acronym
- GS-Wean Tpiece
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07324382
- Acronym / sponsor ID
- GS-Wean Tpiece / GS-Wean: T-piece SBT
- Keywords
- Airway extubation, Extubation failure, Weaning Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 7 Jan 2026 (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.
This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on T-piece. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions:
- One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated.
- Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.
Detailed description
Adaptive design for sample size. The study will include up to a maximum of 4.000 patients. First interim analysis will be performed after complete data is available for the first 500 eligible patients. The Bayesian logistic regression model will be adjusted to provide posterior probabilities that will be compared with threshold values to evaluate stopping decisions. Extensive simulations were conducted to develop and understand adaptive design performance, interim analysis timing, and decision criteria. The trial may be stopped early for efficacy or futility. Secondary outcomes will be analyzed with a gatekeeping procedure to preserve overall type I error at 0.05. Thus, the assessment of statistical significance of secondary outcomes will be performed only if the preceding outcome in the hierarchy met the threshold for statistical significance. No adjustment for multiple comparisons will be applied for analyses of tertiary outcomes and subgroups. Thus, these results should be interpreted as exploratory. Secondary outcomes tested in hierarchical order will be: (1) Mechanical ventilation free days within 28 days; (2) Hospital free days within 28 days; (3) Mortality within 28 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-hour positive pressure ventilation | Experimental | Other: One-hour positive pressure ventilation |
| Immediate extubation | Active comparator | Other: Immediate extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged > 18 years.
- Admitted to the intensive care unit (surgical or medical).
- With endotracheal intubation.
- Mechanical ventilation for more than 72 hours.
- Who underwent successful spontaneous breathing trial (according to the study protocol) and is considered able to be extubated.
Key exclusion criteria (8 listed)
- Patients unable to obey commands.
- With non-planned extubation.
- Neuromuscular disease and cervical spinal cord injury.
- Tracheostomy.
- Contraindication for cardiopulmonary resuscitation or reintubation.
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 |
|---|---|---|
| One-hour positive pressure ventilationAs soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated. | Other | One-hour positive pressure ventilation |
| Immediate extubationThe patient is extubated immediately after the success of the spontaneous breathing trial. | Other | Immediate extubation |
Primary outcome
Number of Participants With Extubation Failure Within 7 Days
Time frame: 7 days (from randomization through Day 7 after randomization)
Extubation failure is defined as a composite endpoint of reintubation or death within 7 days after randomization.
3 secondary outcomes
Ventilator-Free Days Through Day 28
Time frame: 28 days (from randomization through Day 28 after randomization)
Hospital-Free Days Through Day 28
Time frame: 28 days (from randomization through Day 28 after randomization)
Number of Participants Who Died Within 28 Days
Time frame: 28 days (from randomization through Day 28 after randomization)
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 22 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.
Questions about this trial
What is this clinical trial studying?
A study testing One-hour positive pressure ventilation and Immediate extubation in people with Airway Extubation and Extubation Failure, run by Hospital do Coracao.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Aline B Pereira (+55 (47) 99181-8400, linibp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Extubation Failure Within 7 Days (time frame: 7 days (from randomization through Day 7 after randomization)). 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 22 Sep 2026.