Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

Not Applicable

Recruiting

• Conditions: Ventilator Weaning
• Interventions: Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 1; Diagnostic Test: Spontaneous breathing trial (SBT) crossover sequence 2

• Registration Number: NCT04222205
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2143

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover sequence 1	Spontaneous breathing trial (SBT) crossover sequence 1	Cluster-randomization crossover sequence 1: T-piece during odd-numbered months and inspiratory pressure augmentation during even-numbered months.
Crossover sequence 2	Spontaneous breathing trial (SBT) crossover sequence 2	Cluster-randomization crossover sequence 2: T-piece during even-numbered months and inspiratory pressure augmentation during odd-numbered months.

Primary Outcome Measures

Name	Time	Method
Successful liberation from invasive mechanical ventilation	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 Outcome Measures

Name	Time	Method
ICU mortality	ICU discharge, up to 28 days after the initial SBT	Proportion of death in the ICU.
28-day mortality	28 days	Probability of death in 28 days using kaplan-meier estimator.
Successful liberation from invasive and noninvasive mechanical ventilation	ICU discharge, up to 28 days after the initial SBT	Proportion of successful liberation from invasive and noninvasive mechanical ventilation in the ICU.
Successful liberation from invasive mechanical ventilation	28 days	Proportion of successful liberation from invasive mechanical ventilation on day 28 from intubation.
Use of noninvasive ventilation after extubation	Five days from extubation	Proportion of use of noninvasive ventilation (\>24 hours) after extubation.
Time to successful liberation from invasive mechanical ventilation	28 days	Time to successful liberation from invasive mechanical ventilation using competing-risks analysis.
Time to successful liberation from invasive and noninvasive mechanical ventilation	28 days	Time to successful liberation from invasive and noninvasive mechanical ventilation using competing-risks analysis.
Initial SBT success	During the ICU stay, up to 28 days	Proportion of initial SBT success among patients who have started an SBT.
Intubation free days	28 days	The number of days that a patient is alive and free from intubation.
Adjusted risk ratio of successful liberation from invasive mechanical ventilation	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.
Extubation failure	Five days from extubation	Proportion of extubation failure among patients undergoing planned extubation.
Proportion of planned extubation	ICU discharge, up to 28 days after the initial SBT	Proportion of planned extubation in the ICU

Trial Locations

Locations (3)

National Taiwan University Hospital Hsin-Chu Branch; 🇨🇳 Hsin-Chu, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Please Select, Taiwan

National Taiwan University Hospital Yunlin Branch; 🇨🇳 Yunlin, Taiwan