WeaningP-WeanNCT05719194
Effect of a Personalized Weaning Strategy on Weaning Success
A study testing Standard SBT and SBT with T-piece or PSV in people with Weaning and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 9 sites in France.
Trial summary
Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning, Mechanical Ventilation, Intubation
- What is being tested?
- Standard SBT and SBT with T-piece or PSV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 691 participants
- Where
- 9 sitesFrance
- Study dates
- 14 Mar 2023to 11 Mar 2026
- 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
None listed.
Who cannot join
- Acute cerebral pathology requiring admission to intensive care and/or mechanical ventilation with tracheal intubation for neurological reasons (Glasgow score <13 at the time of intubation or CT scan abnormality): hemorrhagic stroke without or with vascular malformation (aneurysm, arterio-venous malformation...), ischemic stroke, head trauma, cerebral anoxo-ischemia after cardiac arrest.
- Tetraplegic or paraplegic patients with lesion level higher than D8.
- Peripheral neuromuscular pathology (underlying myopathy or myasthenia).
- ICU's Neuromyopathy.
- Tracheostomy.
- Patients with a decision of non-reintubation or terminal intubation.
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- Pregnant or lactating women.
- Patients already included in this study.
- Patients under guardianship, curatorship or safeguard of justice.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU de Bordeaux
Bordeaux
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU de Grenoble
Grenoble
CHU de Lille
Lille
CHU de Lyon - Hôpital Lyon Sud
Lyon
CHU de Montpellier
Montpellier
CHU de Nantes
Nantes
CHU de Saint-Etienne
Saint-Etienne
CHU de Toulouse
Toulouse
About this study
Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it.
Even when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.
Read more
There is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.
Studies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).
The purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, heart disease) improves weaning success compared with usual practice.
Read the detailed description
Before the study begin, all participating centers will be randomized to determine the time between the control and the interventional period. Patients included in the study will not be randomized individually but will be managed either according to the standard of care of the service or according to the personalized strategy (according to the stepped wedge group of the center).
- Control period: Patients will be subjected to a weaning strategy in accordance with the usual care practices of the service (evaluation of the criteria of weanability, the modalities of the spontaneous breathing trial and extubation)
- Interventional period: Patients will undergo a protocolized and standardized weaning strategy, including a daily assessment of weaning criteria, and a weaning trial (PSV or T-piece) whose modalities will be defined by the presence or the absence of weaning induced pulmonary oedema risk factors. These are :
- Obesity defined as BMI greater than 30 kg/m²
- Suspected or known COPD
- Heart disease whether it is structural (hypertrophic, dilated, valvular), functional (diastolic or systolic dysfunction), ischemic, or dysrhythmic.
Step 1 :
Daily assessment of weaning criteria in accordance with the study protocol
Step 2 :
- No risk factors : spontaneous breathing trial for 1 hour with pressure support ventilation (setting a pressure support level of 5 to 8 cm of water with no PEEP)
- Risk factors : spontaneous breathing trial with a T-piece for 1 hour, measuring protein and hemoglobin by blood sample before and after the trial.
Step 3 : Reconnecting the patient for at least 30 minutes and extubation if the SBT is successful. If not, the optimization of cardiac function or fluid overload will be the responsibility of the clinician.
Decisions regarding the use of non-invasive ventilation (NIV) or high-flow nasal oxygenation, will be made based on each centre\'s expertise and current clinical practice to minimize interference with the study procedure. However, knowing the recent data and the possible superiority of NIV in preventing post-extubation respiratory failure for high risk patients, investigators will be strongly encouraged to prioritize the prophylactic use of NIV (over high-flow nasal oxygenation) after tracheal extubation.
Patients will be assessed by members of the investigating center\&amp;#39;s research team (under the supervision of the centre\'s investigators) at least daily during hospitalization in the ICU and until day 28 post-randomization, as well as at discharge and at 90 days.
- Conditions
- Weaning, Mechanical Ventilation, Intubation
- Being tested
- Standard SBT, SBT with T-piece or PSV
- Keywords
- WIPO, Extubation, Spontaneous Breathing Trial, T-piece, Pressure Support Ventilation, Weaning strategy, Personalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard SBTOther
Weaning strategy in accordance with the care practices of the department, regarding the assessment of weaning criteria, SBT and extubation modalities.
SBT with T-piece or PSVOther
- Risk factors of WIPO
Step 1 : Daily assessment of weaning criteria in accordance with the study protocol.
Step 2 : Spontaneous breathing trial with T-piece for an hour. Measure of protein and haemoglobin by blood sample before and after the trial.
Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful.
If SBT failed : no extubation and new SBT the next day. Optimization of cardiac function or fluid overload will be in charge of the investigator.
- No risk factors of WIPO
Step 1 : Daily assessment of weaning criteria in accordance with the study protocol.
Step 2 : Spontaneous breathing trial with pressure support ventilation (pressure support from 5 to 8 cmH20 - PEEP at 0 cmH20) for an hour.
Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful.
| Study group | Role | What they receive |
|---|---|---|
| Standard intervention | Active comparator | Not described Receives: Other: Standard SBT |
| Personalized intervention - WIPO risk factors vs no risk factors | Experimental | Not described Receives: Other: SBT with T-piece or PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at day 28, reintubation at 72 hours, ventilatory free days (VFDs) from first spontaneous breathing trial to day 28.
Composite score including those three criteria such that mortality is a more severe outcome than reintubation and the number of VFDs, and reintubation is a more severe outcome than the number of VFDs
Measured: 28 days
Secondary outcomes (11)
Rate of extubation success after the first SBT.
Measured: 72 hours from first SBT
Rate of reintubation
Measured: 72 hours from first SBT
Rate of reintubation
Measured: 72 hours from extubation
Reintubation rate within 7 days of extubation.
Measured: 7 days after extubation
Time from first SBT to extubation.
Measured: 28 days
SBT failure rate
Defined by respiratory rate increase of 50% or > 35/min, dyspnea, SpO2 < 88% or decrease of 5%, heart rate increase > 20%, systolic blood pressure increase > 20%, agitation, sweating.
Measured: 28 days
Number of days without mechanical ventilation
Measured: From day one of first SBT to day 28
Length of stay in the ICU and in the hospital.
Measured: 90 days
Mortality of ICU stay/hospital stay.
Measured: 90 days
Mortality at day 28.
Measured: 28 days
Mortality at day 90.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start14 Mar 2023
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaningStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Pragmatic, controlled, multicenter, stepped wedge cluster randomized trial, considering centers as clusters.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jules Audard, Study chair, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719194
- Sponsor's protocol ID
- P-Wean PHRC IR 2020 AUDARD
- Acronym
- P-Wean
- Status last verified
- May 2026
- First submitted
- 30 Jan 2023
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Personalized Weaning Strategy on Weaning Success
- ClinicalTrials.gov ID
- NCT05719194
- Acronym / sponsor ID
- P-Wean / P-Wean PHRC IR 2020 AUDARD
- Conditions
- Weaning, Mechanical Ventilation, Intubation
- Keywords
- WIPO, Extubation, Spontaneous Breathing Trial, T-piece, Pressure Support Ventilation, Weaning strategy, Personalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 8 Feb 2023 (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.
Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it.
Even when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.
There is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.
Studies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).
The purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, heart disease) improves weaning success compared with usual practice.
Detailed description
Before the study begin, all participating centers will be randomized to determine the time between the control and the interventional period. Patients included in the study will not be randomized individually but will be managed either according to the standard of care of the service or according to the personalized strategy (according to the stepped wedge group of the center).
- Control period: Patients will be subjected to a weaning strategy in accordance with the usual care practices of the service (evaluation of the criteria of weanability, the modalities of the spontaneous breathing trial and extubation)
- Interventional period: Patients will undergo a protocolized and standardized weaning strategy, including a daily assessment of weaning criteria, and a weaning trial (PSV or T-piece) whose modalities will be defined by the presence or the absence of weaning induced pulmonary oedema risk factors. These are :
- Obesity defined as BMI greater than 30 kg/m²
- Suspected or known COPD
- Heart disease whether it is structural (hypertrophic, dilated, valvular), functional (diastolic or systolic dysfunction), ischemic, or dysrhythmic.
Step 1 :
Daily assessment of weaning criteria in accordance with the study protocol
Step 2 :
- No risk factors : spontaneous breathing trial for 1 hour with pressure support ventilation (setting a pressure support level of 5 to 8 cm of water with no PEEP)
- Risk factors : spontaneous breathing trial with a T-piece for 1 hour, measuring protein and hemoglobin by blood sample before and after the trial.
Step 3 : Reconnecting the patient for at least 30 minutes and extubation if the SBT is successful. If not, the optimization of cardiac function or fluid overload will be the responsibility of the clinician.
Decisions regarding the use of non-invasive ventilation (NIV) or high-flow nasal oxygenation, will be made based on each centre\'s expertise and current clinical practice to minimize interference with the study procedure. However, knowing the recent data and the possible superiority of NIV in preventing post-extubation respiratory failure for high risk patients, investigators will be strongly encouraged to prioritize the prophylactic use of NIV (over high-flow nasal oxygenation) after tracheal extubation.
Patients will be assessed by members of the investigating center\&amp;#39;s research team (under the supervision of the centre\'s investigators) at least daily during hospitalization in the ICU and until day 28 post-randomization, as well as at discharge and at 90 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, controlled, multicenter, stepped wedge cluster randomized trial, considering centers as clusters.
| Arm | Type | Receives |
|---|---|---|
| Standard intervention | Active comparator | Other: Standard SBT |
| Personalized intervention - WIPO risk factors vs no risk factors | Experimental | Other: SBT with T-piece or PSV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Acute cerebral pathology requiring admission to intensive care and/or mechanical ventilation with tracheal intubation for neurological reasons (Glasgow score <13 at the time of intubation or CT scan abnormality): hemorrhagic stroke without or with vascular malformation (aneurysm, arterio-venous malformation...), ischemic stroke, head trauma, cerebral anoxo-ischemia after cardiac arrest.
- Tetraplegic or paraplegic patients with lesion level higher than D8.
- Peripheral neuromuscular pathology (underlying myopathy or myasthenia).
- ICU's Neuromyopathy.
- Tracheostomy.
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 |
|---|---|---|
| Standard SBTWeaning strategy in accordance with the care practices of the department, regarding the assessment of weaning criteria, SBT and extubation modalities. | Other | Standard intervention |
| SBT with T-piece or PSV- Risk factors of WIPO Step 1 : Daily assessment of weaning criteria in accordance with the study protocol. Step 2 : Spontaneous breathing trial with T-piece for an hour. Measure of protein and haemoglobin by blood sample before and after the trial. Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful. If SBT failed : no extubation and new SBT the next day. Optimization of cardiac function or fluid overload will be in charge of the investigator. - No risk factors of WIPO Step 1 : Daily assessment of weaning criteria in accordance with the study protocol. Step 2 : Spontaneous breathing trial with pressure support ventilation (pressure support from 5 to 8 cmH20 - PEEP at 0 cmH20) for an hour. Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful. | Other | Personalized intervention - WIPO risk factors vs no risk factors |
Primary outcome
Mortality at day 28, reintubation at 72 hours, ventilatory free days (VFDs) from first spontaneous breathing trial to day 28.
Time frame: 28 days
Composite score including those three criteria such that mortality is a more severe outcome than reintubation and the number of VFDs, and reintubation is a more severe outcome than the number of VFDs
11 secondary outcomes
Rate of extubation success after the first SBT.
Time frame: 72 hours from first SBT
Rate of reintubation
Time frame: 72 hours from first SBT
Rate of reintubation
Time frame: 72 hours from extubation
Reintubation rate within 7 days of extubation.
Time frame: 7 days after extubation
Time from first SBT to extubation.
Time frame: 28 days
SBT failure rate
Time frame: 28 days
Number of days without mechanical ventilation
Time frame: From day one of first SBT to day 28
Length of stay in the ICU and in the hospital.
Time frame: 90 days
Mortality of ICU stay/hospital stay.
Time frame: 90 days
Mortality at day 28.
Time frame: 28 days
Mortality at day 90.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
Jules Audard study chair
University Hospital, Clermont-Ferrand
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard SBT and SBT with T-piece or PSV in people with Weaning and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 9 sites in France.
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 0 inclusion and 9 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality at day 28, reintubation at 72 hours, ventilatory free days (VFDs) from first spontaneous breathing trial to day 28. (time frame: 28 days). 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 8 May 2026.