Weaning From Mechanical VentilationTiP-ExNCT04227639
T-piece Versus Pressure-support for the Spontaneous Breathing Trial
A study testing T-piece trial and Pressure-support trial in people with Weaning From Mechanical Ventilation and Extubation, run by Poitiers University Hospital at 1 site in France.
Trial summary
The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation, Extubation
- What is being tested?
- T-piece trial and Pressure-support trial
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2020to 7 Sep 2021
- 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
- Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h
- Patients at high-risk of reintubation according to the following criteria: Patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
- Patient meeting all weaning criteria according to the international conference consensus on weaning.
- Respiratory rate ≤ 35 breaths per minute,
- Adequate oxygenation defined as SpO2 > 90% with FiO2 ≤ 0.4 or PaO2/FiO2 > 150 mm Hg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,
- Adequate cough,
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- Patient awake with a Richmond Agitation-Sedation Scale between +1 and -2
- No continuous sedation,
- Hemodynamic stability with no need for vasopressors (or minimal dosis).
- Informed consent given by the relatives or the patient himself.
Who cannot join
- Patients admitted for traumatic brain injury
- Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis)
- Do-not-reintubate order at time of the first spontaneous breathing trial
- Patient previously included in the study
- No Health insurance coverage
- People under protection: Pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection.
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: T-piece Versus Pressure-support for the Spontaneous Breathing Trial Before Extubation in Patients at High-risk of Reintubation: a Multicenter Randomized Controlled Trial
The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.
To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.
Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.
- Conditions
- Weaning From Mechanical Ventilation, Extubation
- Being tested
- T-piece trial, Pressure-support trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-piece trialProcedure or surgery
T-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min)
Pressure-support trialProcedure or surgery
Pressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display.
| Study group | Role | What they receive |
|---|---|---|
| T-piece trial | Active comparator | In patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial. Receives: Procedure: T-piece trial |
| Pressure-Support trial | Experimental | In patients assigned to experimental group all spontaneous breathing trials will be performed with a pressure-support level of 8 cm H2O without positive end-expiratory pressure. Receives: Procedure: Pressure-support trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator-free days at day 28
The number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation (intubation or tracheostomy) between the first spontaneous breathing trial (day 1) and day 28.
Measured: Day 28
Secondary outcomes (9)
The number of days alive and without mechanical ventilation (including intubation or non-invasive ventilation) between the first spontaneous breathing trial (day 1) and day 28.
Measured: Between Day 1 and Day 28
The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial.
Measured: Hour 72, Day 7
The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning
Measured: Day 28
The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours.
Measured: Hour 72
The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients
Measured: Day 28
The number of patients reintubated within the 72 hours and within the 7 days following extubation.
Measured: Day 28
The number of patients with post-extubation respiratory failure within the 7 days following extubation.
Measured: Day 28
Length of stay in ICU in days.
Measured: Day 90
Numbers of patients died in ICU, at day 28 and at day 90.
Measured: Day 28 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start31 Jan 2020
- Primary completion7 Jun 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Weaning From Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud W. THILLE, Pr, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227639
- Sponsor's protocol ID
- TiP-Ex
- Other IDs
- 2019-A02151-56
- Acronym
- TiP-Ex
- Status last verified
- May 2022
- First submitted
- 7 Jan 2020
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available after reasonable request and it has been discussed among the steering committee
Publications
Metais M, Frat JP, Ehrmann S, Pene F, Decavele M, Terzi N, Prat G, Martin M, Contou D, Gacouin A, Bourenne J, Girault C, Vinsonneau C, Dellamonica J, Labro G, Jochmans S, Herbland A, Quenot JP, Devaquet J, Benzekri D, Ragot S, Thille AW, Coudroy R; FLORALI-IM study group and the REVA Research Network. Factors associated with ICU mortality and long-term outcomes in immunocompromised patients admitted to the intensive care unit for acute respiratory failure. Ann Intensive Care. 2025 Oct 30;15(1):175. doi: 10.1186/s13613-025-01578-1.
PubMed 41168567Coudroy R, Lejars A, Rodriguez M, Frat JP, Rault C, Arrive F, Le Pape S, Thille AW. Physiologic Effects of Reconnection to the Ventilator for 1 Hour Following a Successful Spontaneous Breathing Trial. Chest. 2024 Jun;165(6):1406-1414. doi: 10.1016/j.chest.2024.01.038. Epub 2024 Jan 29.
PubMed 38295948Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.
PubMed 36286317Thille AW, Coudroy R, Gacouin A, Ehrmann S, Contou D, Dangers L, Romen A, Guitton C, Lacave G, Quenot JP, Lacombe B, Pradel G, Terzi N, Prat G, Labro G, Reignier J, Beduneau G, Dellamonica J, Nay MA, Rouze A, Delbove A, Sedillot N, Mira JP, Bourenne J, Lautrette A, Argaud L, Levrat Q, Devaquet J, Vivier E, Azais MA, Leroy C, Dres M, Robert R, Ragot S, Frat JP; REVA research network. T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX). BMJ Open. 2020 Nov 24;10(11):e042619. doi: 10.1136/bmjopen-2020-042619.
PubMed 33234658
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-piece Versus Pressure-support for the Spontaneous Breathing Trial Before Extubation in Patients at High-risk of Reintubation: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04227639
- Acronym / sponsor ID
- TiP-Ex / TiP-Ex
- Conditions
- Weaning From Mechanical Ventilation, Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 13 Jan 2020 (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 main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.
To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.
Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-piece trial | Active comparator | Procedure: T-piece trialIn patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial. |
| Pressure-Support trial | Experimental | Procedure: Pressure-support trialIn patients assigned to experimental group all spontaneous breathing trials will be performed with a pressure-support level of 8 cm H2O without positive end-expiratory pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h
- Patients at high-risk of reintubation according to the following criteria: Patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
- Patient meeting all weaning criteria according to the international conference consensus on weaning.
- Informed consent given by the relatives or the patient himself.
Key exclusion criteria (7 listed)
- Patients admitted for traumatic brain injury
- Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis)
- Do-not-reintubate order at time of the first spontaneous breathing trial
- Patient previously included in the study
- No Health insurance coverage
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 |
|---|---|---|
| T-piece trialT-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min) | Procedure or surgery | T-piece trial |
| Pressure-support trialPressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display. | Procedure or surgery | Pressure-Support trial |
Primary outcome
Number of ventilator-free days at day 28
Time frame: Day 28
The number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation (intubation or tracheostomy) between the first spontaneous breathing trial (day 1) and day 28.
9 secondary outcomes
The number of days alive and without mechanical ventilation (including intubation or non-invasive ventilation) between the first spontaneous breathing trial (day 1) and day 28.
Time frame: Between Day 1 and Day 28
The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial.
Time frame: Hour 72, Day 7
The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning
Time frame: Day 28
The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours.
Time frame: Hour 72
The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients
Time frame: Day 28
The number of patients reintubated within the 72 hours and within the 7 days following extubation.
Time frame: Day 28
The number of patients with post-extubation respiratory failure within the 7 days following extubation.
Time frame: Day 28
Length of stay in ICU in days.
Time frame: Day 90
Numbers of patients died in ICU, at day 28 and at day 90.
Time frame: Day 28 and Day 90
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 12 May 2022.
- Derived from this study: PubMed 41168567Metais M, Frat JP, Ehrmann S, Pene F, Decavele M, Terzi N, Prat G, Martin M, Contou D, Gacouin A, Bourenne J, Girault C, Vinsonneau C, Dellamonica J, Labro G, Jochmans S, Herbland A, Quenot JP, Devaquet J, Benzekri D, Ragot S, Thille AW, Coudroy R; FLORALI-IM study group and the REVA Research Network. Factors associated with ICU mortality and long-term outcomes in immunocompromised patients admitted to the intensive care unit for acute respiratory failure. Ann Intensive Care. 2025 Oct 30;15(1):175. doi: 10.1186/s13613-025-01578-1.
- Derived from this study: PubMed 38295948Coudroy R, Lejars A, Rodriguez M, Frat JP, Rault C, Arrive F, Le Pape S, Thille AW. Physiologic Effects of Reconnection to the Ventilator for 1 Hour Following a Successful Spontaneous Breathing Trial. Chest. 2024 Jun;165(6):1406-1414. doi: 10.1016/j.chest.2024.01.038. Epub 2024 Jan 29.
- Derived from this study: PubMed 36286317Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.
- Derived from this study: PubMed 33234658Thille AW, Coudroy R, Gacouin A, Ehrmann S, Contou D, Dangers L, Romen A, Guitton C, Lacave G, Quenot JP, Lacombe B, Pradel G, Terzi N, Prat G, Labro G, Reignier J, Beduneau G, Dellamonica J, Nay MA, Rouze A, Delbove A, Sedillot N, Mira JP, Bourenne J, Lautrette A, Argaud L, Levrat Q, Devaquet J, Vivier E, Azais MA, Leroy C, Dres M, Robert R, Ragot S, Frat JP; REVA research network. T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX). BMJ Open. 2020 Nov 24;10(11):e042619. doi: 10.1136/bmjopen-2020-042619.
- Individual participant dataSharing planned: Yes. Data will be made available after reasonable request and it has been discussed among the steering committee
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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.
Arnaud W. THILLE, Pr principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-piece trial and Pressure-support trial in people with Weaning From Mechanical Ventilation and Extubation, run by Poitiers University Hospital 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 10 inclusion and 7 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 12 May 2022. 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?
Number of ventilator-free days at day 28 (time frame: Day 28). 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 NCT04227639, which also lists 4 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 12 May 2022.