Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients

Launched by TAIPEI MEDICAL UNIVERSITY HOSPITAL · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to test if overweight and obese patients in the ICU are ready to have their breathing tube removed after being on a breathing machine. The two methods being compared are called pressure support ventilation (PSV) and the T-piece trial. The goal is to find out which method helps patients successfully breathe on their own without needing the tube put back in within 72 hours.

Adults who have a body mass index (BMI) of 25 or higher and have been on a breathing machine for more than 24 hours may be eligible to take part. Before the tube is taken out, participants will be randomly assigned to try one of the two breathing tests for one hour. During this time, doctors will closely watch their breathing and overall health to decide if they are ready to be extubated (have the breathing tube removed). To join, patients need to be awake, stable in their heart and lung function, and able to cough well. Some people, such as those with certain brain injuries, nerve or muscle diseases, or with a tracheostomy (a different type of breathing tube), cannot join this study. This trial aims to help doctors find the best way to support overweight and obese patients in safely coming off the breathing machine.

Gender

ALL

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.