Ventilation Support for the PREvenTion of EXTubation Failure

Study Overview
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Brief Summary
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Reintubation after failed extubation would be associated with increased mortality. Therefore, extubation failure remains a major concern in ICU. Few randomized controlled studies have assessed the benefit for a systematic respiratory support (noninvasive ventilation or high flow nasal cannula) applied at the time of extubation to reduce reintubation rates in patients at high and low risk for reintubation. In addition, these studies reported discordant results. Therefore, there are some concerns regarding effectiveness and systematic uptake of a respiratory support after extubation into usual practice.

Detailed Description
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The aim of this trial is to determine whether a protocolized postextubation respiratory support including High-flow Nasal Oxygen (HFNO) and Noninvasive Ventilation (NIV) could reduce the rate of reintubation in comparison with usual practice. Therefore, all consecutively eligible patients for the study, will be assigned to a protocol arm in accordance with the randomized period

Official Title
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Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial

Conditions
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Extubation Failure

Intervention / Treatment
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* Procedure: protocolized postextubation support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Intubated more than 24 hours in the ICU Ready for a scheduled extubation then extubated Exclusion Criteria: Contraindication to HFNO or NIV Underlying chronic neuromuscular disease Unplanned extubation (accidental or self-extubation) With a do-not-reintubate order at time of extubation Tracheotomia

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: Sequential Assignment
Interventional Model Description: A stepped wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control period<br>the control period corresponds to usual care of centers | |
| Experimental: protocolized period<br>the protocolized period corresponds to a protocolized use of HFNO or NIV after extubation | Procedure: protocolized postextubation support<br>* The intervention corresponds to a protocolized use of HFNO or NIV after extubation in accordance with the risk of extubation failure: a) 24H HFNO in patient at low risk of extubation failure b) 48H NIV+/-HFNO in patients at high risk of extubation failure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reintubation | Reintubation following extubation | 7 days following extubation |