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NCT Number: NCT07114289

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients had undergone intubation and mechanical ventilation for more than 24 hours prior to the first spontaneous breathing trial.
  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Spontaneous breathing trial using pressure support ventilation

Procedure

Patients will receive low level pressure support ventilation for 1 hour before extubation

Spontaneous breathing trial using T-Piece

Procedure

Patients will receive a T-piece with oxygen for 1 hour before extubation

Primary outcomes

  1. Successful extubation within 72 hours

    Time frame: Within 72 hours after extubation

Study contacts

Contact information is provided by the study sponsor or research team.

Respiratory therapist

CONTACT

[email protected]

+886-937870463

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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