Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation (SBT-TIP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator Weaning
• Intervention / Treatment: Diagnostic test: Spontaneous breathing trial (SBT) crossover sequence 1; Diagnostic test: Spontaneous breathing trial (SBT) crossover sequence 2

• Study Type: Interventional
• Enrollment (Estimated): 2143
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheng-Yuan Ruan, MD, PhD; Phone Number: 886223123456; Email: syruan@ntu.edu.tw

Study Locations

• Taiwan
  • Hsin-Chu, Taiwan
    • Recruiting
    • National Taiwan University Hospital Hsin-Chu Branch
    • Contact: Chia-Ling Chang, MD
  • Yunlin, Taiwan, 63247
    • Recruiting
    • National Taiwan University Hospital Yunlin Branch
    • Contact: Yen-Fu Chen, MD; Phone Number: 88656330002
  • Please Select
    • Taipei, Please Select, Taiwan, 10002
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Sheng-Yuan Ruan, MD, PhD; Phone Number: 886223123456; Email: syruan@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Crossover sequence 1; 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; 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.
Experimental: Crossover sequence 2; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Daniel Fu-Chang Tsai, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Weaning; Clinical trial; Respiratory failure; Mechanical ventilation; Spontaneous breathing trial
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 201901036RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The individual participant data are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No