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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00258-41 | Other Identifier | ANSM |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weaning strategy with direct extubation (no spontaneous breathing trial) | Experimental |
| |
| Weaning strategy with extubation only after a successful spontaneous breathing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weaning strategy with direct extubation (no spontaneous breathing trial) | Procedure | Patients will be extubated within the 60 minutes following randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 28 days after randomization |
| Occurrence of reintubation |
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Inclusion Criteria:
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.
Exclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin DRES, Pr | Contact | 01 42 16 77 97 | martin.dres@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Martin DRES, Pr | Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié Salpêtrière | Paris | 75013 | France |
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.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| Weaning strategy with extubation only after a successful spontaneous breathing | Procedure | Patients will undergo a spontaneous breathing trial and will be extubated only in case of successful spontaneous breathing |
|
Rate of of reintubation with predefined criteria |
| 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 | Within 28 days after randomization |
| Duration of weaning process from randomization until successful extubation | Number of days from randomization until successful extubation | 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 | 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 | 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 | Within 28 days after randomization |
| Length of stay in the ICU and hospital stay | Number of days in the ICU and in the hospital | Within 28 days after randomization |
| ICU and hospital mortality | Proportion of patients who died in the ICU and in the hospital | Within 28 days after randomization |
| Day 28 mortality | Rate of patients who died at day 28 after randomization | Within 28 days after randomization |
| Cumulative incidence of successful extubation over time | Probability of being successfully extubated from randomization until day 28 | Within 28 days after randomization |
| Duration between randomization and SBT trial | The time between randomization and the onset of the SBT, minutes | Within 28 days after randomization |
| Barriers to extubation: logistical, timing, family or patient. | Open | Within 28 days after randomization |
| Duration between extubation decision and extubation | Time between extubation decision and extubation, minutes | Within 28 days after randomization |