Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University Hospital
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients with tracheostomy.
Patients who had been admitted for traumatic brain injury.
Patients who had preexisting peripheral neuromuscular disease (underlying myopathy or myasthenia gravis).
Patients who had a do-not-reintubate order at the time of the initial spontaneous breathing trial were excluded
Trial design
Design model
Parallel
Treatments tested in this trial
Spontaneous breathing trial using pressure support ventilation
Procedure/SurgeryPatients will receive low level pressure support ventilation for 1 hour before extubation
Spontaneous breathing trial using T-Piece
Procedure/SurgeryPatients will receive a T-piece with oxygen for 1 hour before extubation
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PSV groupActive comparator 1 intervention
Group B: T-Piece groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Successful extubation within 72 hours
Time frame
Within 72 hours after extubationSponsors and contacts
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Source ClinicalTrials.gov