Ventilation Support for the PREvenTion of EXTubation Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-02-29

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.

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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

Conditions

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Extubation Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A stepped wedge cluster randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control period

the control period corresponds to usual care of centers

Group Type NO_INTERVENTION

No interventions assigned to this group

protocolized period

the protocolized period corresponds to a protocolized use of HFNO or NIV after extubation

Group Type EXPERIMENTAL

protocolized postextubation support

Intervention Type PROCEDURE

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

Interventions

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protocolized postextubation support

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No