NCT07114289Recruiting
Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients
Comparison of Pressure Support Ventilation and T-Piece as Spontaneous Breathing Trials Before Extubation Among Obese and Overweight Patients
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 29 Sept 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Taipei Medical University Hospital
- Diseases
- Obesity
- NCT number
- NCT07114289
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 29 Sept 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who had preexisting peripheral neuromuscular disease (underlying myopathy or myasthenia gravis).
Other
- Patients with tracheostomy.
- Patients who had been admitted for traumatic brain injury.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.