Extubation FailurePRETEEXTNCT05550259
Ventilation Support for the PREvenTion of EXTubation Failure
A study testing protocolized postextubation support in people with Extubation Failure, run by University Hospital, Caen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure
- What is being tested?
- protocolized postextubation support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Intubated more than 24 hours in the ICU
- Ready for a scheduled extubation then extubated
Who cannot join
- 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
About this study
Official title: Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial
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.
Read the 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
- Conditions
- Extubation Failure
- Being tested
- protocolized postextubation support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocolized postextubation supportProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| control period | No intervention | the control period corresponds to usual care of centers |
| protocolized period | Experimental | the protocolized period corresponds to a protocolized use of HFNO or NIV after extubation Receives: Procedure: protocolized postextubation support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reintubation
Reintubation following extubation
Measured: 7 days following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550259
- Sponsor's protocol ID
- 3480
- Acronym
- PRETEEXT
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05550259
- Acronym / sponsor ID
- PRETEEXT / 3480
- Conditions
- Extubation Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| control period | No intervention | –the control period corresponds to usual care of centers |
| protocolized period | Experimental | Procedure: protocolized postextubation supportthe protocolized period corresponds to a protocolized use of HFNO or NIV after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Intubated more than 24 hours in the ICU
- Ready for a scheduled extubation then extubated
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protocolized postextubation supportThe 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 | Procedure or surgery | protocolized period |
Primary outcome
Rate of reintubation
Time frame: 7 days following extubation
Reintubation following extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing protocolized postextubation support in people with Extubation Failure, run by University Hospital, Caen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reintubation (time frame: 7 days following extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.