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NCT Number: NCT04222205

Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

Weaning is an important process to gradually separate mechanically ventilated patients from ventilators. A good weaning strategy aims to early identify mechanically ventilated patients who are ready for extubation but not to prematurely extubate them. Spontaneous breathing trial (SBT) is a test to assess the patient's ability to breathe spontaneously when extubated. Several methods have been used to conduct an SBT, including T-piece breathing, low-level pressure support ventilation (PSV) of 5-7 cm H2O, continuous positive airway pressure and automatic tube compensation (ATC).

The investigators hypothesized that an SBT with inspiratory pressure augmentation increases initial SBT success, reduces the length of invasive mechanical ventilation (iMV) support and does not increase reintubation risk as compared with T-piece, which result in a higher proportion of patients successfully liberated from iMV in the inspiratory pressure augmentation group. However, inspiratory pressure augmentation significantly reduces work of breathing on an SBT as compared with T-piece. Patients extubated following an SBT with inspiratory pressure augmentation may experience increased respiratory effort after extubation and this may increase the use of noninvasive ventilation after extubation. An SBT with inspiratory pressure augmentation increases iMV free days but not MV free days as compared with T-piece. Longer iMV free days may be associated with a lower mortality due to fewer iMV related complication.

This study is a pragmatic, cluster-randomized, multiple crossover, multicenter trial to compare SBTs with T-piece versus inspiratory pressure augmentation in weaning outcomes. Mechanically ventilated patients who meet the criteria for readiness to SBT will be included. The patients will use either T-piece or inspiratory pressure augmentation as SBT for weaning according to an ICU-based cluster randomization and crossover sequence.

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Please Select, Taiwan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Admitted to the adult intensive care unit (ICU)
  • Receiving invasive mechanical ventilation via an endotracheal tube
  • Ready to start an SBT* *The criteria of readiness to an SBT include FiO2 ≤ 0.4, PEEP ≤ 8 cmH2O, minute ventilation ≤ 0.15 L/min/predicted body weight, inspiratory pressure or driving pressure ≤ 14 cm H2O, stable cardiovascular status and no worsening of non-pulmonary organ function.

Exclusion criteria

  • Age < 20 years
  • Receiving mechanical ventilation via tracheostomy
  • Mechanical ventilation < 12 hours
  • Invasive ventilation started before the index hospitalization
  • On do-not-intubate order

Treatment and study plan

Spontaneous breathing trial (SBT) crossover sequence 1

Diagnostic Test

SBTs with T-piece breathing for one hour during odd-numbered months and SBTs with inspiratory pressure augmentation for one hour during even-numbered months.

Spontaneous breathing trial (SBT) crossover sequence 2

Diagnostic Test

SBTs with inspiratory pressure augmentation for one hour during odd-numbered months and SBTs with T-piece breathing for one hour during even-numbered months.

Primary outcomes

  1. Successful liberation from invasive mechanical ventilation

    Time frame: ICU discharge, up to 28 days after the initial SBT

    The primary study endpoint is to compare the effect of SBT with T-piece versus inspiratory pressure augmentation on the proportion of patients with successful liberation from invasive mechanical ventilation in the ICU among patients who have started an SBT. Successful liberation is defined as sustaining iMV free for at least five days after extubation.

Secondary outcomes

  1. Successful liberation from invasive and noninvasive mechanical ventilation

    Time frame: ICU discharge, up to 28 days after the initial SBT

    Proportion of successful liberation from invasive and noninvasive mechanical ventilation in the ICU.

  2. Successful liberation from invasive mechanical ventilation

    Time frame: 28 days

    Proportion of successful liberation from invasive mechanical ventilation on day 28 from intubation.

  3. Time to successful liberation from invasive mechanical ventilation

    Time frame: 28 days

    Time to successful liberation from invasive mechanical ventilation using competing-risks analysis.

  4. Time to successful liberation from invasive and noninvasive mechanical ventilation

    Time frame: 28 days

    Time to successful liberation from invasive and noninvasive mechanical ventilation using competing-risks analysis.

  5. Intubation free days

    Time frame: 28 days

    The number of days that a patient is alive and free from intubation.

  6. Adjusted risk ratio of successful liberation from invasive mechanical ventilation

    Time frame: ICU discharge, up to 28 days after the initial SBT

    Adjusted risk ratio of successful liberation from invasive mechanical ventilation for T-piece versus inspiratory pressure augmentation group.

  7. Initial SBT success

    Time frame: During the ICU stay, up to 28 days

    Proportion of initial SBT success among patients who have started an SBT.

  8. Extubation failure

    Time frame: Five days from extubation

    Proportion of extubation failure among patients undergoing planned extubation.

  9. Proportion of planned extubation

    Time frame: ICU discharge, up to 28 days after the initial SBT

    Proportion of planned extubation in the ICU

  10. Use of noninvasive ventilation after extubation

    Time frame: Five days from extubation

    Proportion of use of noninvasive ventilation (>24 hours) after extubation.

  11. ICU mortality

    Time frame: ICU discharge, up to 28 days after the initial SBT

    Proportion of death in the ICU.

  12. 28-day mortality

    Time frame: 28 days

    Probability of death in 28 days using kaplan-meier estimator.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A Cluster-Randomized Crossover Trial to Compare Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

Acronym: SBT-TIP

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jan 9, 2020
Registry last updated
Jun 10, 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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