Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

NCT ID: NCT04222205

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2025-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Crossover sequence 1

Cluster-randomization crossover sequence 1:

T-piece during odd-numbered months and inspiratory pressure augmentation during even-numbered months.

Group Type: ACTIVE_COMPARATOR

Spontaneous breathing trial (SBT) crossover sequence 1

Intervention Type: 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.

Crossover sequence 2

Cluster-randomization crossover sequence 2:

T-piece during even-numbered months and inspiratory pressure augmentation during odd-numbered months.

Group Type: EXPERIMENTAL

Spontaneous breathing trial (SBT) crossover sequence 2

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Admitted to the adult intensive care unit (ICU)

2. Receiving invasive mechanical ventilation via an endotracheal tube

3. 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

1. Age < 20 years

2. Receiving mechanical ventilation via tracheostomy

3. Mechanical ventilation < 12 hours

4. Invasive ventilation started before the index hospitalization

5. On do-not-intubate order

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Fu-Chang Tsai, MD, PhD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Please Select, Taiwan

National Taiwan University Hospital Hsin-Chu Branch

Taoyuan District, , Taiwan

National Taiwan University Hospital Yunlin Branch

Yunlin, , Taiwan

Countries

Taiwan

Other Identifiers

201901036RINA

Identifier Type: -

Identifier Source: org_study_id