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Breathing tube showdown: PSV vs T-Piece in overweight ICU patients

NCT ID NCT07114289

Symptom relief Sponsor: Taipei Medical University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two methods of breathing trials for overweight and obese ICU patients before removing their breathing tube. One hundred adults with a BMI of 25 or higher who have been on a ventilator for over 24 hours will be randomly assigned to either pressure support ventilation or a T-piece for one hour. The goal is to see which method leads to more successful tube removal without needing to be put back on the ventilator within 72 hours.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. BMI ≥ 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. Informed consent provided by the patient or their relatives. 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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extubation Mechanical ventilation Obesity &amp; overweight Respiratory failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110, Taiwan

More trials for these conditions

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