Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07114289

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

Led by Taipei Medical University Hospital · Updated on 2025-11-17

100

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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?

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients intubated and on mechanical ventilation for over 24 hours before the first 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 90-160 mmHg, no or minimal vasopressor use (<0.2 µg/kg per min)
  • Respiratory rate 35 breaths/min or less
  • Adequate oxygen levels: SpO2 above 90% with FiO2 0.4 or less, or PaO2/FiO2 above 150 mmHg with PEEP 8 cmH2O or less
  • Adequate cough strength (MIP less than -20 cmH2O)
  • Awake state with Richmond Agitation-Sedation Scale score between +1 and -2 or Glasgow Coma Scale above 8
  • No continuous sedation
  • Informed consent given by patient or relatives
Not Eligible

You will not qualify if you...

  • Having a tracheostomy
  • Admission for traumatic brain injury
  • Preexisting peripheral neuromuscular diseases such as myopathy or myasthenia gravis
  • Do-not-reintubate order at the time of the first spontaneous breathing trial
  • Having already undergone a first spontaneous breathing trial
  • Extubation without having a spontaneous breathing trial
  • Being pregnant, breastfeeding, under guardianship, or legal protection
  • Refusal to participate in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Taipei Medical University Hospital

Taipei, Taiwan, 110

Actively Recruiting

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Research Team

R

Respiratory therapist

CONTACT

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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