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RecruitingNCT07114289Updated Nov 17, 2025

Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients

An interventional study of Spontaneous breathing trial using pressure support ventilation and Spontaneous breathing trial using T-Piece in Mechanical Ventilation, Extubation and Obesity &Amp; Overweight, sponsored by Taipei Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Taipei Medical University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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?

02

Conditions studied

  • Mechanical Ventilation
  • Extubation
  • Obesity &Amp; Overweight
  • Respiratory Failure
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 100 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Taipei Medical University Hospital is the lead sponsor of 64 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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. ≥ 25 kg/m². 4. Meeting all the Inter national Consensus Conference on weaning criteria:

  1. 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).
  2. Respiratory rate ≤ 35 breaths/min.
  3. Adequate oxygenation, defined as either SpO2 > 90% with FiO2 ≤ 0.4, or PaO2/FiO2 > 150 mmHg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O.
  4. Adequate cough strength (MIP \< -20 cmH2O).
  5. An awake state, defined as a score of Richmond Agitation-Sedation Scale between +1 and -2, or Glasgow Coma Scale > 8.
  6. No continuous sedation. 5. provided by the patient or their relatives.

Exclusion criteria

Exclusion Criteria:

  1. Patients with tracheostomy.
  2. Patients who had been admitted for traumatic brain injury.
  3. Patients who had preexisting peripheral neuromuscular disease (underlying myopathy or myasthenia gravis).
  4. Patients who had a do-not-reintubate order at the time of the initial spontaneous breathing trial were excluded
  5. Patients who have already undergone a first spontaneous breathing trial.
  6. Patients who had undergone extubation without an SBT
  7. Protected populations: pregnant or breastfeeding women, individuals under guardianship, or those under legal protection.
  8. Patients who refused to participate during the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    PSV group

    Procedure: Spontaneous breathing trial using pressure support ventilation

  • Active comparator
    T-Piece group

    Procedure: Spontaneous breathing trial using T-Piece

Interventions

  • ProcedureSpontaneous breathing trial using pressure support ventilation

    Patients will receive low level pressure support ventilation for 1 hour before extubation

  • ProcedureSpontaneous breathing trial using T-Piece

    Patients will receive a T-piece with oxygen for 1 hour before extubation

06

What researchers measure

Primary outcomes

  1. Successful extubation within 72 hours

    Time frame: Within 72 hours after extubation

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Mar 2027, 18 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 18 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2025
First posted
Aug 11, 2025
StartActual
Sep 29, 2025
Primary completionEst.
Mar 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Nov 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07114289
Lead sponsor
Taipei Medical University Hospital
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Sep 29, 2025
Primary completion
Mar 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Nov 17, 2025

Study contacts

Respiratory therapist
Contact
lynnho0326@gmail.com
+886-937870463

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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