Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extubation Failure
- Sponsor
- University Hospital, Caen
- Enrollment
- 1100
- Primary Endpoint
- Rate of reintubation
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of reintubation
Time Frame: 7 days following extubation
Reintubation following extubation