Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

Ventilator Weaning Clinical Trial

— SBT-TIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222205
• Other study ID #: 201901036RINA
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: National Taiwan University Hospital
• Contact: Sheng-Yuan Ruan, MD, PhD
• Phone: 886223123456
• Email: syruan[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2143
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Ventilator Weaning

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	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

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Successful liberation from invasive and noninvasive mechanical ventilation	Proportion of successful liberation from invasive and noninvasive mechanical ventilation in the ICU.	ICU discharge, up to 28 days after the initial SBT
Secondary	Successful liberation from invasive mechanical ventilation	Proportion of successful liberation from invasive mechanical ventilation on day 28 from intubation.	28 days
Secondary	Time to successful liberation from invasive mechanical ventilation	Time to successful liberation from invasive mechanical ventilation using competing-risks analysis.	28 days
Secondary	Time to successful liberation from invasive and noninvasive mechanical ventilation	Time to successful liberation from invasive and noninvasive mechanical ventilation using competing-risks analysis.	28 days
Secondary	Intubation free days	The number of days that a patient is alive and free from intubation.	28 days
Secondary	Adjusted risk ratio of successful liberation from invasive mechanical ventilation	Adjusted risk ratio of successful liberation from invasive mechanical ventilation for T-piece versus inspiratory pressure augmentation group.	ICU discharge, up to 28 days after the initial SBT
Secondary	Initial SBT success	Proportion of initial SBT success among patients who have started an SBT.	During the ICU stay, up to 28 days
Secondary	Extubation failure	Proportion of extubation failure among patients undergoing planned extubation.	Five days from extubation
Secondary	Proportion of planned extubation	Proportion of planned extubation in the ICU	ICU discharge, up to 28 days after the initial SBT
Secondary	Use of noninvasive ventilation after extubation	Proportion of use of noninvasive ventilation (>24 hours) after extubation.	Five days from extubation
Secondary	ICU mortality	Proportion of death in the ICU.	ICU discharge, up to 28 days after the initial SBT
Secondary	28-day mortality	Probability of death in 28 days using kaplan-meier estimator.	28 days