Ventilation Support for the PREvenTion of EXTubation Failure (PRETEEXT)

Caen University Hospital

Status: Not yet enrolling

Conditions: Extubation Failure

Treatments: Procedure: protocolized postextubation support

Study type: Interventional

Funder types: Other

Identifiers

NCT05550259

3480

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

control period

No Intervention group

Description:

the control period corresponds to usual care of centers

protocolized period

Experimental group

Description:

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

Treatment:

Procedure: protocolized postextubation support