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Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

NCT04222205 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2143

Last updated 2025-06-10

No results posted yet for this study

Summary

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.

Conditions

  • Ventilator Weaning

Interventions

DIAGNOSTIC_TEST

Spontaneous breathing trial (SBT) crossover sequence 1

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.

DIAGNOSTIC_TEST

Spontaneous breathing trial (SBT) crossover sequence 2

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Daniel Fu-Chang Tsai, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-12-29
Completion
2025-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04222205 on ClinicalTrials.gov