Ventilation Support for the PREvenTion of EXTubation Failure

Not Applicable

Not yet recruiting

• Conditions: Extubation Failure
• Interventions: Procedure: protocolized postextubation support

• Registration Number: NCT05550259
• Lead Sponsor: University Hospital, Caen

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

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Submitted: 2022-09-30
• Study Start: 2022-10
• Last Update Posted: 2022-10-03
• Primary Completion: 2024-01
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
protocolized period	protocolized postextubation support	the protocolized period corresponds to a protocolized use of HFNO or NIV after extubation

Primary Outcome Measures

Name	Time	Method
Rate of reintubation	7 days following extubation	Reintubation following extubation