Pressure-support versus T-piece breathing test for overweight and obese adults on ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study enrolls adults with BMI ≥25 who have been invasively mechanically ventilated for more than 24 hours and meet standard weaning criteria. Participants are randomly assigned to a one-hour spontaneous breathing trial using either pressure support ventilation (PSV) or a T-piece, after which treating clinicians decide on extubation. The primary outcome is successful extubation, defined as not requiring reintubation within 72 hours. Secondary data collected include respiratory parameters, need for ventilatory support after extubation, and ICU length of stay.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Medical University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Respiratory therapist
• Email: lynnho0326@gmail.com
• Phone: +886-937870463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.