Actively Recruiting
Comparison of Pressure Support Ventilation and T-Piece as Spontaneous Breathing Trials Before Extubation Among Overweight and Obese Patients
Led by Taipei Medical University Hospital · Updated on 2025-11-17
100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate which spontaneous breathing trial method better prepares overweight and obese adult ICU patients for extubation, the removal of the breathing tube. The study focuses on adults with a body mass index (BMI) of 25 or higher who have been on invasive mechanical ventilation for more than 24 hours. The goal is to determine which method leads to a higher rate of successful extubation, defined as not needing reintubation within 72 hours after extubation. Participants will be randomly assigned to one of two groups before extubation. One group will receive a spontaneous breathing trial using low-level pressure support ventilation (PSV) for one hour, while the other group will receive a spontaneous breathing trial using a T-piece with oxygen for one hour. After the trial, doctors will decide if the patient is ready for extubation. During the study, patients will be monitored for vital signs and respiratory stability. Researchers will track whether extubation is successful within 72 hours, which is the main outcome measure. Participants must meet specific clinical criteria before the trial and provide informed consent. The study is sponsored by Taipei Medical University Hospital and does not include additional extension or long-term follow-up periods.
CONDITIONS
Brief Title
Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients intubated and on mechanical ventilation for more than 24 hours before the first spontaneous breathing trial
- Adults aged 18 years or older
- Body mass index (BMI) of 25 kg/m² or higher
- Stable vital signs: heart rate under 140 beats/min, systolic blood pressure between 90-160 mmHg, minimal or no vasopressor use
- Respiratory rate of 35 breaths/min or less
- Adequate oxygen levels with SpO2 above 90% on FiO2 of 0.4 or less, or PaO2/FiO2 above 150 mmHg with PEEP 8 cmH2O or less
- Adequate cough strength with maximal inspiratory pressure less than -20 cmH2O
- Awake state with Richmond Agitation-Sedation Scale between +1 and -2, or Glasgow Coma Scale above 8
- No continuous sedation
- Informed consent given by patient or relatives
You will not qualify if you...
- Patients with a tracheostomy
- Patients admitted for traumatic brain injury
- Patients with preexisting peripheral neuromuscular diseases such as myopathy or myasthenia gravis
- Patients with do-not-reintubate orders at the time of the initial spontaneous breathing trial
- Patients who have already undergone a first spontaneous breathing trial
- Patients extubated without a spontaneous breathing trial
- Protected populations including pregnant or breastfeeding women, individuals under guardianship, or legal protection
- Patients who refuse to participate during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 hour
Participants undergo a spontaneous breathing trial using either pressure support ventilation or a T-piece for 1 hour before extubation.
1 visit (in-person)
Duration - Up to 72 hours
Participants are monitored for successful extubation within 72 hours after the breathing trial.
Monitoring during hospital stay
Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
R
Respiratory therapist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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