Weaning From Mechanical Ventilation, ExtubationT-REXNCT07019636
Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure
A study testing Weaning strategy with direct extubation (no spontaneous breathing trial) and Weaning strategy with extubation only after a successful spontaneous breathing in people with Weaning From Mechanical Ventilation, Extubation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This randomized controlled open label trial aims at comparing a weaning strategy including a spontaneous breathing trial as a prerequisite for extubation to a weaning strategy without a spontaneous breathing trial (direct extubation) in patients with readiness to be weaned criteria and considered at low risk of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weaning From Mechanical Ventilation, Extubation
- What is being tested?
- Weaning strategy with direct extubation (no spontaneous breathing trial) and Weaning strategy with extubation only after a successful spontaneous breathing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2026to 15 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years and < 65 years old
- Nasal or oral intubation longer than 24 hours and less than 4 days
- Satisfaction to each following weaning readiness criteria:
- Respiratory rate < 35 cycles per minute
- SpO2 >90% with FiO2<40% and PEEP<8 cmH2O
- RASS score between -2 and +2 with low level or no sedatives
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- No need or low doses of vasopressors
- Adequate cough
- Inform consent by patient or legal representative or the close relative or emergency inclusion procedure.
Who cannot join
- Risk factor for extubation failure as defined by any of the following criteria:
- Chronic cardiac disease (left ejection fraction below 45%, documented history of cardiogenic pulmonary edema, permanent atrial fibrillation).
- Chronic respiratory disease (severe COPD, documented restricted lung disease or obesity-hypoventilation syndrome)
- Body mass index > 30 kg/m2
- Airway patency problems, including high risk of developing laryngeal edema, inability to deal with respiratory secretions, brain injury, documented swallowing disorders
- Tracheostomy
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- Underlying chronic neuromuscular disease
- Do not resuscitate orders
- Pregnant or lacting woman
- Patient under guardianship
- Patient without healthcare insurance
- Refusal to participate and sign the written consent
- Patients with traumatic brain injury
- Post surgery patients
- Patients included in another interventional trial that may have an impact on the evaluation criteria of the present study
- Patient under AME
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié Salpêtrière
Paris, 75013
Martin DRES, Pr, 01 42 16 77 97, martin.dres@aphp.fr
About this study
This randomized controlled open label trial aims at comparing a weaning strategy including a spontaneous breathing trial as a prerequisite for extubation to a weaning strategy without a spontaneous breathing trial (direct extubation) in patients with readiness to be weaned criteria and considered at low risk of extubation failure. The main endpoint will be the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful spontaneous breathing trial (SBT).
Read the detailed description
Weaning from mechanical ventilation is a critical step in the course on an ICU stay. Separation from the ventilator should be done at the earliest possible time, but extubation failure is an adverse event that should be avoided. The most common decision-making strategy regarding weaning and extubation is to combine a daily assessment of the patient's "readiness to wean" and a spontaneous breathing trial before to extubate.
The result of the SBT (passed of failed) is often viewed as a "go - no go" indicator of whether or not patients are ready for extubation, but daily practice indicates that the assessment of the SBT is subjective with a frequent natural tendency for clinicians to keep their patients on the 'safe' side, i.e., considering them as not being ready for extubation. However, the results of the SBT should be interpreted based on the pre-test probability. Conducting a SBT in patients while the pre-test probability of success is high will result in false negatives which are likely to delay the decision of extubation. In addition, a pointless SBT may expose patients to anxiety, air hunger and dyspnea which are poorly detected by caregivers. The hypothesis of the present project is that in patients who are at low risk of extubation failure, a SBT is useless and once readiness to wean criteria are met, direct extubation would increase the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful SBT.
- Being tested
- Weaning strategy with direct extubation (no spontaneous breathing trial), Weaning strategy with extubation only after a successful spontaneous breathing
- Keywords
- Weaning, Mechanical ventilation, Extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning strategy with direct extubation (no spontaneous breathing trial)Procedure or surgery
Patients will be extubated within the 60 minutes following randomization
Weaning strategy with extubation only after a successful spontaneous breathingProcedure or surgery
Patients will undergo a spontaneous breathing trial and will be extubated only in case of successful spontaneous breathing
| Study group | Role | What they receive |
|---|---|---|
| Weaning strategy with direct extubation (no spontaneous breathing trial) | Experimental | Not described Receives: Procedure: Weaning strategy with direct extubation (no spontaneous breathing trial) |
| Weaning strategy with extubation only after a successful spontaneous breathing | Active comparator | Not described Receives: Procedure: Weaning strategy with extubation only after a successful spontaneous breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
The rate of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
Measured: From Day 1 to Day 3
Secondary outcomes (14)
Occurrence of post extubation acute respiratory failure
Rate of post extubation acute respiratory failure defined by the persistence of more than 30 minutes of at least two predefined criteria
Measured: Within 28 days after randomization
Occurrence of reintubation
Rate of of reintubation with predefined criteria
Measured: Within 28 days after randomization
Unplanned use of non-invasive ventilation or high flow nasal oxygen
Rate of unplanned use of non-invasive ventilation or high flow nasal oxygen
Measured: Within 28 days after randomization
Duration of weaning process from randomization until successful extubation
Number of days from randomization until successful extubation
Measured: Within 28 days after randomization
Total duration of invasive mechanical ventilation from intubation until successful extubation
Total number of days of invasive mechanical ventilation from intubation until successful extubation
Measured: Within 28 days after randomization
Number of Ventilator Free Days between randomization until Day 28
Number of days without the ventilator and alive from randomization until Day 28
Measured: Within 28 days after randomization
Occurrence of ventilator acquired pneumonia
Ventilator acquired pneumonia will be defined by quantitative distal bronchoalveolar lavage cultures growing ≥104cfu/mL
Measured: Within 28 days after randomization
Length of stay in the ICU and hospital stay
Number of days in the ICU and in the hospital
Measured: Within 28 days after randomization
ICU and hospital mortality
Proportion of patients who died in the ICU and in the hospital
Measured: Within 28 days after randomization
Day 28 mortality
Rate of patients who died at day 28 after randomization
Measured: Within 28 days after randomization
Cumulative incidence of successful extubation over time
Probability of being successfully extubated from randomization until day 28
Measured: Within 28 days after randomization
Duration between randomization and SBT trial
The time between randomization and the onset of the SBT, minutes
Measured: Within 28 days after randomization
Barriers to extubation: logistical, timing, family or patient.
Open
Measured: Within 28 days after randomization
Duration between extubation decision and extubation
Time between extubation decision and extubation, minutes
Measured: Within 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Jul 2026
- Primary completion18 Sep 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning From Mechanical Ventilation, ExtubationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin DRES, Pr, Principal investigator, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019636
- Sponsor's protocol ID
- APHP240912
- Other IDs
- 2025-A00258-41
- Acronym
- T-REX
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure
- ClinicalTrials.gov ID
- NCT07019636
- Acronym / sponsor ID
- T-REX / APHP240912
- Keywords
- Weaning, Mechanical ventilation, Extubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 18 Sep 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 13 Jun 2025 (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.
This randomized controlled open label trial aims at comparing a weaning strategy including a spontaneous breathing trial as a prerequisite for extubation to a weaning strategy without a spontaneous breathing trial (direct extubation) in patients with readiness to be weaned criteria and considered at low risk of extubation failure. The main endpoint will be the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful spontaneous breathing trial (SBT).
Detailed description
Weaning from mechanical ventilation is a critical step in the course on an ICU stay. Separation from the ventilator should be done at the earliest possible time, but extubation failure is an adverse event that should be avoided. The most common decision-making strategy regarding weaning and extubation is to combine a daily assessment of the patient's "readiness to wean" and a spontaneous breathing trial before to extubate.
The result of the SBT (passed of failed) is often viewed as a "go - no go" indicator of whether or not patients are ready for extubation, but daily practice indicates that the assessment of the SBT is subjective with a frequent natural tendency for clinicians to keep their patients on the 'safe' side, i.e., considering them as not being ready for extubation. However, the results of the SBT should be interpreted based on the pre-test probability. Conducting a SBT in patients while the pre-test probability of success is high will result in false negatives which are likely to delay the decision of extubation. In addition, a pointless SBT may expose patients to anxiety, air hunger and dyspnea which are poorly detected by caregivers. The hypothesis of the present project is that in patients who are at low risk of extubation failure, a SBT is useless and once readiness to wean criteria are met, direct extubation would increase the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful SBT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weaning strategy with direct extubation (no spontaneous breathing trial) | Experimental | Procedure: Weaning strategy with direct extubation (no spontaneous breathing trial) |
| Weaning strategy with extubation only after a successful spontaneous breathing | Active comparator | Procedure: Weaning strategy with extubation only after a successful spontaneous breathing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age older than 18 years and < 65 years old
- Nasal or oral intubation longer than 24 hours and less than 4 days
- Satisfaction to each following weaning readiness criteria:
- Inform consent by patient or legal representative or the close relative or emergency inclusion procedure.
Key exclusion criteria (16 listed)
- Risk factor for extubation failure as defined by any of the following criteria:
- Tracheostomy
- Underlying chronic neuromuscular disease
- Do not resuscitate orders
- Pregnant or lacting woman
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 |
|---|---|---|
| Weaning strategy with direct extubation (no spontaneous breathing trial)Patients will be extubated within the 60 minutes following randomization | Procedure or surgery | Weaning strategy with direct extubation (no spontaneous breathing trial) |
| Weaning strategy with extubation only after a successful spontaneous breathingPatients will undergo a spontaneous breathing trial and will be extubated only in case of successful spontaneous breathing | Procedure or surgery | Weaning strategy with extubation only after a successful spontaneous breathing |
Primary outcome
Proportion of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
Time frame: From Day 1 to Day 3
The rate of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
14 secondary outcomes
Occurrence of post extubation acute respiratory failure
Time frame: Within 28 days after randomization
Occurrence of reintubation
Time frame: Within 28 days after randomization
Unplanned use of non-invasive ventilation or high flow nasal oxygen
Time frame: Within 28 days after randomization
Duration of weaning process from randomization until successful extubation
Time frame: Within 28 days after randomization
Total duration of invasive mechanical ventilation from intubation until successful extubation
Time frame: Within 28 days after randomization
Number of Ventilator Free Days between randomization until Day 28
Time frame: Within 28 days after randomization
Occurrence of ventilator acquired pneumonia
Time frame: Within 28 days after randomization
Length of stay in the ICU and hospital stay
Time frame: Within 28 days after randomization
ICU and hospital mortality
Time frame: Within 28 days after randomization
Day 28 mortality
Time frame: Within 28 days after randomization
Cumulative incidence of successful extubation over time
Time frame: Within 28 days after randomization
Duration between randomization and SBT trial
Time frame: Within 28 days after randomization
Barriers to extubation: logistical, timing, family or patient.
Time frame: Within 28 days after randomization
Duration between extubation decision and extubation
Time frame: Within 28 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Martin DRES, Pr principal investigator
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weaning strategy with direct extubation (no spontaneous breathing trial) and Weaning strategy with extubation only after a successful spontaneous breathing in people with Weaning From Mechanical Ventilation, Extubation, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin DRES, Pr (01 42 16 77 97, martin.dres@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours. (time frame: From Day 1 to Day 3). 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 17 Jul 2026.