Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial

Study Overview
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Brief Summary
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The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.

Official Title
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Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation

Conditions
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Critically Ill Adult Patients With Difficult Weaning

Intervention / Treatment
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* Procedure: Assisted strategy
* Procedure: Non assisted strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years old or more Intubated and ventilated in intensive care unit for more than 24 hours Patient ready for weaning evaluation Failure of a first T-piece SBT Exclusion Criteria: Chronic neuromuscular disease Guillain-Barré Syndrome Central nervous system disease with consciousness disorder Tracheostomy Chronic disease with life expectancy less than 1 year Pregnancy, breast feeding Withholding life support regarding a reintubation Prisoner or patient interned in psychiatric hospital Guardianship Language barrier Lack of medical insurance Lack of the patient's consent (or of the next of kin where appropriate) Patient under an exclusion period after enrollment in another research study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assisted strategy<br>Ability to be weaned is determined with pressure support and positive end-expiratory pressure. | Procedure: Assisted strategy<br>* Daily spontaneous breathing trial (SBT) with 7 cmH2O pressure support and 5 cmH2O positive end-expiratory pressure are performed to assess weanability. In case of success, a SBT with T-piece is performed to determine if the patients is at high risk of extubation failure. In this case and/or in the presence of risk factors, systematic non-invasive ventilation is applied after extubation.<br>|
| Active Comparator: Non assisted strategy<br>Ability to be weaned is determined with T-piece. | Procedure: Non assisted strategy<br>* Daily spontaneous breathing trials (SBT) with T-piece are performed to assess weanability. In the presence of risk factors, systematic non-invasive ventilation is applied after extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (hours) to successful extubation | Successful extubation is defined as extubation without retintubation within the 7 following days. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of first extubation | percentage (%) of patients with a first successful extubation divided by the total number of patients per group | 90 days | 
| Invasive mechanical ventilation duration | time (hours) spent on invasive mechanical ventilation since inclusion | 90 days | 
| duration of non-invasive and invasive mechanical ventilation | time (hours) spent on invasive or non mechanical ventilation since inclusion | 90 days | 
| ventilator-free days at Day 90 | 90 minus the number of days spent on invasive mechanical ventilation (days) since inclusion. Zero day is allocated to dead patients. | 90 days | 
| Intensive care unit length of stay | time (days) spent in intensive care unit from inclusion until discharge or death | 90 days | 
| hospital length of stay | time (days) spent in the hospital from inclusion until discharge or death | 90 days | 
| Day 90 mortality | percentage (%) of patients dead at Day 90 | 90 days | 
| reintubation rate | percentage (%) of the number of patients with any reintubation divided by the number of patients per group | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care, spontaneous breathing trial, T-piece, positive end-expiratory pressure, difficult weaning