Critically Ill Adult Patients With Difficult WeaningSBT-ICUNCT03861117
Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial
A study testing Assisted strategy and Non assisted strategy in people with Critically Ill Adult Patients With Difficult Weaning, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Adult Patients With Difficult Weaning
- What is being tested?
- Assisted strategy and Non assisted strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2019to 1 Jun 2023
- 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
- Patient 18 years old or more
- Intubated and ventilated in intensive care unit for more than 24 hours
- Patient ready for weaning evaluation
- Failure of a first T-piece SBT
Who cannot join
- Chronic neuromuscular disease
- Guillain-Barré Syndrome
- Central nervous system disease with consciousness disorder
- Tracheostomy
- Chronic disease with life expectancy less than 1 year
- Pregnancy, breast feeding
Show all 13Show fewer
- Withholding life support regarding a reintubation
- Prisoner or patient interned in psychiatric hospital
- Guardianship
- Language barrier
- Lack of medical insurance
- Lack of the patient's consent (or of the next of kin where appropriate)
- Patient under an exclusion period after enrollment in another research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation
The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.
- Being tested
- Assisted strategy, Non assisted strategy
- Keywords
- Critical care, spontaneous breathing trial, T-piece, positive end-expiratory pressure, difficult weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted strategyProcedure or surgery
Daily spontaneous breathing trial (SBT) with 7 cmH2O pressure support and 5 cmH2O positive end-expiratory pressure are performed to assess weanability. In case of success, a SBT with T-piece is performed to determine if the patients is at high risk of extubation failure. In this case and/or in the presence of risk factors, systematic non-invasive ventilation is applied after extubation.
Non assisted strategyProcedure or surgery
Daily spontaneous breathing trials (SBT) with T-piece are performed to assess weanability. In the presence of risk factors, systematic non-invasive ventilation is applied after extubation.
| Study group | Role | What they receive |
|---|---|---|
| Assisted strategy | Experimental | Ability to be weaned is determined with pressure support and positive end-expiratory pressure. Receives: Procedure: Assisted strategy |
| Non assisted strategy | Active comparator | Ability to be weaned is determined with T-piece. Receives: Procedure: Non assisted strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (hours) to successful extubation
Successful extubation is defined as extubation without retintubation within the 7 following days.
Measured: 90 days
Secondary outcomes (8)
Rate of first extubation
percentage (%) of patients with a first successful extubation divided by the total number of patients per group
Measured: 90 days
Invasive mechanical ventilation duration
time (hours) spent on invasive mechanical ventilation since inclusion
Measured: 90 days
duration of non-invasive and invasive mechanical ventilation
time (hours) spent on invasive or non mechanical ventilation since inclusion
Measured: 90 days
ventilator-free days at Day 90
90 minus the number of days spent on invasive mechanical ventilation (days) since inclusion. Zero day is allocated to dead patients.
Measured: 90 days
Intensive care unit length of stay
time (days) spent in intensive care unit from inclusion until discharge or death
Measured: 90 days
hospital length of stay
time (days) spent in the hospital from inclusion until discharge or death
Measured: 90 days
Day 90 mortality
percentage (%) of patients dead at Day 90
Measured: 90 days
reintubation rate
percentage (%) of the number of patients with any reintubation divided by the number of patients per group
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 posted4 Mar 2019
- Study start10 May 2019
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically Ill Adult Patients With Difficult WeaningStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861117
- Sponsor's protocol ID
- 69HCL18_0982
- Other IDs
- 2019-A00106-51
- Acronym
- SBT-ICU
- Status last verified
- Dec 2025
- First submitted
- 1 Mar 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mezidi M, Yonis H, Chauvelot L, Danjou W, Dhelft F, Bazzani A, Girard M, Bitker L, Richard JC. Pressure support and positive end-expiratory pressure versus T-piece during spontaneous breathing trial in difficult weaning from mechanical ventilation: study protocol for the SBT-ICU study. Trials. 2022 Dec 12;23(1):993. doi: 10.1186/s13063-022-06896-4.
PubMed 36503500Mezidi M, Yonis H, Chauvelot L, Deniel G, Dhelft F, Gaillet M, Noirot I, Folliet L, Chabert P, David G, Danjou W, Baboi L, Bettinger C, Bernon P, Girard M, Provoost J, Bazzani A, Bitker L, Richard JC. Spontaneous breathing trial with pressure support on positive end-expiratory pressure and extensive use of non-invasive ventilation versus T-piece in difficult-to-wean patients from mechanical ventilation: a randomized controlled trial. Ann Intensive Care. 2024 Apr 17;14(1):59. doi: 10.1186/s13613-024-01290-6.
PubMed 38630372
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation
- ClinicalTrials.gov ID
- NCT03861117
- Acronym / sponsor ID
- SBT-ICU / 69HCL18_0982
- Keywords
- Critical care, spontaneous breathing trial, T-piece, positive end-expiratory pressure, difficult weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 4 Mar 2019 (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.
The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted strategy | Experimental | Procedure: Assisted strategyAbility to be weaned is determined with pressure support and positive end-expiratory pressure. |
| Non assisted strategy | Active comparator | Procedure: Non assisted strategyAbility to be weaned is determined with T-piece. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient 18 years old or more
- Intubated and ventilated in intensive care unit for more than 24 hours
- Patient ready for weaning evaluation
- Failure of a first T-piece SBT
Key exclusion criteria (13 listed)
- Chronic neuromuscular disease
- Guillain-Barré Syndrome
- Central nervous system disease with consciousness disorder
- Tracheostomy
- Chronic disease with life expectancy less than 1 year
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 |
|---|---|---|
| Assisted strategyDaily spontaneous breathing trial (SBT) with 7 cmH2O pressure support and 5 cmH2O positive end-expiratory pressure are performed to assess weanability. In case of success, a SBT with T-piece is performed to determine if the patients is at high risk of extubation failure. In this case and/or in the presence of risk factors, systematic non-invasive ventilation is applied after extubation. | Procedure or surgery | Assisted strategy |
| Non assisted strategyDaily spontaneous breathing trials (SBT) with T-piece are performed to assess weanability. In the presence of risk factors, systematic non-invasive ventilation is applied after extubation. | Procedure or surgery | Non assisted strategy |
Primary outcome
Time (hours) to successful extubation
Time frame: 90 days
Successful extubation is defined as extubation without retintubation within the 7 following days.
8 secondary outcomes
Rate of first extubation
Time frame: 90 days
Invasive mechanical ventilation duration
Time frame: 90 days
duration of non-invasive and invasive mechanical ventilation
Time frame: 90 days
ventilator-free days at Day 90
Time frame: 90 days
Intensive care unit length of stay
Time frame: 90 days
hospital length of stay
Time frame: 90 days
Day 90 mortality
Time frame: 90 days
reintubation rate
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 19 Dec 2025.
- Background: PubMed 36503500Mezidi M, Yonis H, Chauvelot L, Danjou W, Dhelft F, Bazzani A, Girard M, Bitker L, Richard JC. Pressure support and positive end-expiratory pressure versus T-piece during spontaneous breathing trial in difficult weaning from mechanical ventilation: study protocol for the SBT-ICU study. Trials. 2022 Dec 12;23(1):993. doi: 10.1186/s13063-022-06896-4.
- Results publication: PubMed 38630372Mezidi M, Yonis H, Chauvelot L, Deniel G, Dhelft F, Gaillet M, Noirot I, Folliet L, Chabert P, David G, Danjou W, Baboi L, Bettinger C, Bernon P, Girard M, Provoost J, Bazzani A, Bitker L, Richard JC. Spontaneous breathing trial with pressure support on positive end-expiratory pressure and extensive use of non-invasive ventilation versus T-piece in difficult-to-wean patients from mechanical ventilation: a randomized controlled trial. Ann Intensive Care. 2024 Apr 17;14(1):59. doi: 10.1186/s13613-024-01290-6.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted strategy and Non assisted strategy in people with Critically Ill Adult Patients With Difficult Weaning, run by Hospices Civils de Lyon at 1 site 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 4 inclusion and 13 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time (hours) to successful extubation (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03861117, which also lists 2 linked publications.
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 19 Dec 2025.