Clinical trial NCT07019636: Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure
Official title: Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ICU Patients Deemed Ready for Separation From the Ventilator
Keywords: Weaning
Mechanical ventilation
Extubation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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:

  1. Respiratory rate \< 35 cycles per minute
  2. SpO2 \>90% with FiO2\<40% and PEEP\<8 cmH2O
  3. RASS score between -2 and +2 with low level or no sedatives
  4. No need or low doses of vasopressors
  5. Adequate cough
* 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:

  * 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
* 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

Primary outcomes:
measure: Proportion of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
timeFrame: From Day 1 to Day 3
Secondary outcomes:
measure: Occurrence of post extubation acute respiratory failure
timeFrame: Within 28 days after randomization
measure: Occurrence of reintubation
timeFrame: Within 28 days after randomization
measure: Unplanned use of non-invasive ventilation or high flow nasal oxygen
timeFrame: Within 28 days after randomization
measure: Duration of weaning process from randomization until successful extubation
timeFrame: Within 28 days after randomization
measure: Total duration of invasive mechanical ventilation from intubation until successful extubation
timeFrame: Within 28 days after randomization
measure: Number of Ventilator Free Days between randomization until Day 28
timeFrame: Within 28 days after randomization
measure: Occurrence of ventilator acquired pneumonia
timeFrame: Within 28 days after randomization
measure: Length of stay in the ICU and hospital stay
timeFrame: Within 28 days after randomization
measure: ICU and hospital mortality
timeFrame: Within 28 days after randomization
measure: Day 28 mortality
timeFrame: Within 28 days after randomization
measure: Cumulative incidence of successful extubation over time
timeFrame: Within 28 days after randomization
measure: Duration between randomization and SBT trial
timeFrame: Within 28 days after randomization
measure: Barriers to extubation: logistical, timing, family or patient.
timeFrame: Within 28 days after randomization
measure: Duration between extubation decision and extubation
timeFrame: Within 28 days after randomization
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
affiliation: Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
name: Martin DRES, Pr
role: PRINCIPAL_INVESTIGATOR
References: