Ventilation Support for the PREvenTion of EXTubation Failure

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05550259

Acronym

PRETEEXT

Enrollment

1100

Registered

2022-09-22

Start date

2022-10-31

Completion date

2024-02-29

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation Failure

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

Interventions

PROCEDUREprotocolized 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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A stepped wedge cluster randomized trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of reintubation	7 days following extubation	Reintubation following extubation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026