Mechanical VentilationNCT07114289
Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients
A study testing Spontaneous breathing trial using pressure support ventilation and Spontaneous breathing trial using T-Piece in people with Mechanical Ventilation and Extubation, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
This study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Extubation, Obesity &Amp; Overweight
- What is being tested?
- Spontaneous breathing trial using pressure support ventilation and Spontaneous breathing trial using T-Piece
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Sep 2025to 31 Jul 2027
- 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
- 1. Patients had undergone intubation and mechanical ventilation for more than 24 hours prior to the first spontaneous breathing trial.
- 2. Adult patients aged ≥ 18 years. 3. BMI ≥ 25 kg/m². 4. Meeting all the Inter national Consensus Conference on weaning criteria:
- Stable vital signs: heart rate < 140 beats/min, systolic blood pressure: 90-160 mmHg, and no use of vasopressors or use of minimal doses (<0.2 µg/kg per min).
- Respiratory rate ≤ 35 breaths/min.
- Adequate oxygenation, defined as either SpO2 > 90% with FiO2 ≤ 0.4, or PaO2/FiO2 > 150 mmHg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O.
- Adequate cough strength (MIP < -20 cmH2O).
- An awake state, defined as a score of Richmond Agitation-Sedation Scale between +1 and -2, or Glasgow Coma Scale > 8.
- No continuous sedation. 5. Informed consent provided by the patient or their relatives.
Who cannot join
- Patients with tracheostomy.
- Patients who had been admitted for traumatic brain injury.
- Patients who had preexisting peripheral neuromuscular disease (underlying myopathy or myasthenia gravis).
- Patients who had a do-not-reintubate order at the time of the initial spontaneous breathing trial were excluded
- Patients who have already undergone a first spontaneous breathing trial.
- Patients who had undergone extubation without an SBT
- Protected populations: pregnant or breastfeeding women, individuals under guardianship, or those under legal protection.
- Patients who refused to participate during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Ho, +886937870463, 124057@h.tmu.edu.tw
About this study
Official title: Comparison of Pressure Support Ventilation and T-Piece as Spontaneous Breathing Trials Before Extubation Among Obese and Overweight Patients
This study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece.
Participants are adults with a body mass index (BMI) of 25 or higher who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours. Before removing the breathing tube, participants will be randomly assigned to receive either a PSV or a T-piece trial for 1 hour. After that, doctors will decide if they are ready for extubation.
The main question this study wants to answer is: Which method leads to a higher rate of successful extubation-defined as not needing to be reintubated within 72 hours?
- Being tested
- Spontaneous breathing trial using pressure support ventilation, Spontaneous breathing trial using T-Piece
- Medical subject headings
- Obesity, Overweight, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous breathing trial using pressure support ventilationProcedure or surgery
Patients will receive low level pressure support ventilation for 1 hour before extubation
Spontaneous breathing trial using T-PieceProcedure or surgery
Patients will receive a T-piece with oxygen for 1 hour before extubation
| Study group | Role | What they receive |
|---|---|---|
| PSV group | Active comparator | Not described Receives: Procedure: Spontaneous breathing trial using pressure support ventilation |
| T-Piece group | Active comparator | Not described Receives: Procedure: Spontaneous breathing trial using T-Piece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful extubation within 72 hours
Measured: Within 72 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start29 Sep 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114289
- Sponsor's protocol ID
- N202412012
- Status last verified
- May 2025
- First submitted
- 4 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pressure Support Ventilation and T-Piece as Spontaneous Breathing Trials Before Extubation Among Obese and Overweight Patients
- ClinicalTrials.gov ID
- NCT07114289
- Acronym / sponsor ID
- N202412012
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Aug 2025 (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 study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece.
Participants are adults with a body mass index (BMI) of 25 or higher who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours. Before removing the breathing tube, participants will be randomly assigned to receive either a PSV or a T-piece trial for 1 hour. After that, doctors will decide if they are ready for extubation.
The main question this study wants to answer is: Which method leads to a higher rate of successful extubation-defined as not needing to be reintubated within 72 hours?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSV group | Active comparator | Procedure: Spontaneous breathing trial using pressure support ventilation |
| T-Piece group | Active comparator | Procedure: Spontaneous breathing trial using T-Piece |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Patients had undergone intubation and mechanical ventilation for more than 24 hours prior to the first spontaneous breathing trial.
- 2. Adult patients aged ≥ 18 years. 3. BMI ≥ 25 kg/m². 4. Meeting all the Inter national Consensus Conference on weaning criteria:
- Stable vital signs: heart rate < 140 beats/min, systolic blood pressure: 90-160 mmHg, and no use of vasopressors or use of minimal doses (<0.2 µg/kg per min).
- Respiratory rate ≤ 35 breaths/min.
- Adequate oxygenation, defined as either SpO2 > 90% with FiO2 ≤ 0.4, or PaO2/FiO2 > 150 mmHg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O.
Key exclusion criteria (8 listed)
- Patients with tracheostomy.
- Patients who had been admitted for traumatic brain injury.
- Patients who had preexisting peripheral neuromuscular disease (underlying myopathy or myasthenia gravis).
- Patients who had a do-not-reintubate order at the time of the initial spontaneous breathing trial were excluded
- Patients who have already undergone a first spontaneous breathing trial.
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 using pressure support ventilationPatients will receive low level pressure support ventilation for 1 hour before extubation | Procedure or surgery | PSV group |
| Spontaneous breathing trial using T-PiecePatients will receive a T-piece with oxygen for 1 hour before extubation | Procedure or surgery | T-Piece group |
Primary outcome
Successful extubation within 72 hours
Time frame: Within 72 hours after extubation
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 17 Nov 2025.
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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.
1 site 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 using pressure support ventilation and Spontaneous breathing trial using T-Piece in people with Mechanical Ventilation and Extubation, run by Taipei Medical University Hospital at 1 site 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 8 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Respiratory therapist (+886-937870463, lynnho0326@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful extubation within 72 hours (time frame: Within 72 hours after extubation). 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 17 Nov 2025.