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

Comparison of Pressure Support Ventilation and T-Piece as Spontaneous Breathing Trials Before Extubation Among Obese and Overweight Patients

This test will see if a one-hour pressure-support or T-piece breathing trial helps overweight and obese adults on a ventilator be successfully extubated without needing reintubation within 72 hours.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Taipei Medical University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT07114289 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (age ≥18) with BMI ≥25 who have been invasively ventilated for over 24 hours and meet international weaning criteria, with informed consent, are the ideal candidates.

Not a fit: Patients with tracheostomy, unstable vital signs, ongoing deep sedation, recent major trauma, or who do not meet weaning criteria are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, this could increase first-attempt extubation rates for overweight and obese patients and reduce time on mechanical ventilation and related complications.

How similar studies have performed: Previous randomized comparisons of PSV and T-piece in general ICU populations have produced mixed results—some favor PSV for comfort or easier weaning, while others show no clear difference—so applying this comparison specifically to overweight and obese patients is relatively novel.

Eligibility criteria

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 this trial is running

Taipei

• Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Respiratory therapist

Conditions Mechanical Ventilation; Extubation; Obesity &Amp; Overweight; Respiratory Failure