Clinical trial NCT04222205: Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
Official title: A Cluster-Randomized Crossover Trial to Compare Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventilator Weaning
Keywords: Clinical trial
Mechanical ventilation
Respiratory failure
Spontaneous breathing trial
Weaning
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 2143
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster-Randomized Crossover Trial
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Successful liberation from invasive mechanical ventilation
timeFrame: ICU discharge, up to 28 days after the initial SBT
Secondary outcomes:
measure: Successful liberation from invasive and noninvasive mechanical ventilation
timeFrame: ICU discharge, up to 28 days after the initial SBT
measure: Successful liberation from invasive mechanical ventilation
timeFrame: 28 days
measure: Time to successful liberation from invasive mechanical ventilation
timeFrame: 28 days
measure: Time to successful liberation from invasive and noninvasive mechanical ventilation
timeFrame: 28 days
measure: Intubation free days
timeFrame: 28 days
measure: Adjusted risk ratio of successful liberation from invasive mechanical ventilation
timeFrame: ICU discharge, up to 28 days after the initial SBT
measure: Initial SBT success
timeFrame: During the ICU stay, up to 28 days
measure: Extubation failure
timeFrame: Five days from extubation
measure: Proportion of planned extubation
timeFrame: ICU discharge, up to 28 days after the initial SBT
measure: Use of noninvasive ventilation after extubation
timeFrame: Five days from extubation
measure: ICU mortality
timeFrame: ICU discharge, up to 28 days after the initial SBT
measure: 28-day mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Please Select
city: Hsin-Chu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
city: Yunlin
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
Study officials:
affiliation: National Taiwan University Hospital
name: Daniel Fu-Chang Tsai, MD, PhD
role: STUDY_CHAIR
References: