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Recruiting NCT07114289

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

No phase Interventional Mechanical Ventilation Extubation Obesity &Amp; Overweight Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spontaneous breathing trial using pressure support ventilation, Spontaneous breathing trial using T-Piece.
Who it may be relevant to
Registry conditions: Mechanical Ventilation, Extubation, Obesity &Amp; Overweight, Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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?

Interventions

  • Procedure Spontaneous breathing trial using pressure support ventilation
    Patients will receive low level pressure support ventilation for 1 hour before extubation
  • Procedure Spontaneous breathing trial using T-Piece
    Patients will receive a T-piece with oxygen for 1 hour before extubation

Primary outcome measures

  • Successful extubation within 72 hours [Time frame: Within 72 hours after extubation]

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:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • Taipei Medical University Hospital — Taipei

Identifiers

NCT: NCT07114289 · N202412012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗