Spontaneous Breathing Trial With T-piece or Inspiratory Pressure

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04222205
Study type	Interventional
Source	National Taiwan University Hospital
Contact	Sheng-Yuan Ruan, MD, PhD
Phone	886223123456
Email	syruan@ntu.edu.tw
Status	Recruiting
Phase	N/A
Start date	December 1, 2019
Completion date	December 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02894177` - Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring for the Prediction of Extubation Failure in the ICU	N/A
Recruiting	`NCT05114551` - ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
Completed	`NCT04011852` - The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Recruiting	`NCT02921347` - Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients	N/A
Recruiting	`NCT02921334` - Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning	N/A
Recruiting	`NCT06055413` - Home-based Optimization of Mechanical Ventilation in Children	N/A
Active, not recruiting	`NCT04023643` - Pediatric Ventilation Weaning	N/A
Completed	`NCT05254691` - WOB and Paediatric Mechanical Ventilation	N/A
Recruiting	`NCT05999526` - Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial	N/A
Active, not recruiting	`NCT02820090` - The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism	N/A
Recruiting	`NCT01131377` - Acetazolamide Facilitates Ventilator Weaning	N/A
Not yet recruiting	`NCT06321848` - Weaning Ventilator Using Heart, Lung And Diaphragm Ultrasound
Completed	`NCT02412202` - Echocardiographic Detection of Extravascular Lung Water Increase During Weaning From Mechanical Ventilation	N/A
Completed	`NCT00445289` - Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units	N/A
Recruiting	`NCT05380687` - Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training	N/A
Terminated	`NCT01535755` - A Protocol to Wean From Noninvasive Mechanical Ventilation	N/A
Completed	`NCT04711759` - Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients	N/A
Completed	`NCT03433105` - Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation
Completed	`NCT00505804` - A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium	Phase 2
Completed	`NCT02946502` - Handgrip Strength Value in Predicting Mechanical Ventilation Weaning	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms