Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

NCT04222205 | Active Not Recruiting DMC

• 1 other identifier: 201901036RINA
• Study Type: interventional
• Target: 2,143
• Locations: 1 country
• Sites: 3

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

Keywords

Clinical trial; Mechanical ventilation; Respiratory failure; Spontaneous breathing trial; Weaning

Outcome Measures

Primary Outcomes (1)

• Successful liberation from invasive mechanical ventilation

  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.

  ICU discharge, up to 28 days after the initial SBT

Secondary Outcomes (12)

• Successful liberation from invasive and noninvasive mechanical ventilation

  ICU discharge, up to 28 days after the initial SBT

• Successful liberation from invasive mechanical ventilation

  28 days

• Time to successful liberation from invasive mechanical ventilation

  28 days

• Time to successful liberation from invasive and noninvasive mechanical ventilation

  28 days

• Intubation free days

  28 days

Study Arms (2)

Crossover sequence 1

ACTIVE COMPARATOR

Cluster-randomization crossover sequence 1: T-piece during odd-numbered months and inspiratory pressure augmentation during even-numbered months.

Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 1

Crossover sequence 2

EXPERIMENTAL

Cluster-randomization crossover sequence 2: T-piece during even-numbered months and inspiratory pressure augmentation during odd-numbered months.

Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 2

Interventions

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.

Crossover sequence 1

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.

Crossover sequence 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (3)

National Taiwan University Hospital

Taipei, Please Select, 10002, Taiwan

Location

National Taiwan University Hospital Hsin-Chu Branch

Taoyuan District, Taiwan

Location

National Taiwan University Hospital Yunlin Branch

Yunlin, 63247, Taiwan

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Serum Bactericidal Test

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Microbial Sensitivity Tests; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic

Study Officials

• Daniel Fu-Chang Tsai, MD, PhD

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-Randomized Crossover Trial

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: January 9, 2020
• Study Start: December 1, 2019
• Primary Completion: December 29, 2024
• Study Completion: June 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

TW (3)