University Hospital, Caen
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.
Extubation Failure
protocolized postextubation support
Not Applicable
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}}
| Study Type : | Interventional |
| Estimated Enrollment : | 1100 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Treatment |
| Official Title : | Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial |
| Actual Study Start Date : | October 2022 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | February 2024 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: control period the control period corresponds to usual care of centers |
|
|
Experimental: protocolized period the protocolized period corresponds to a protocolized use of HFNO or NIV after extubation |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.