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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Taiwan
Taipei Medical University Hospital
RECRUITING
Taipei
Contact Information
Primary
Respiratory therapist
lynnho0326@gmail.com
+886-937870463
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
Active_comparator: PSV group
Active_comparator: T-Piece group
Related Therapeutic Areas
Sponsors
Leads: Taipei Medical University Hospital

This content was sourced from clinicaltrials.gov