Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure (T-REX)

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Weaning From Mechanical Ventilation, Extubation

Treatments

Procedure: Weaning strategy with direct extubation (no spontaneous breathing trial)

Procedure: Weaning strategy with extubation only after a successful spontaneous breathing

Study type

Interventional

Funder types

Other

Identifiers

NCT07019636

2025-A00258-41 (Other Identifier)

APHP240912

Details and patient eligibility

About

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).

Full 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.

Enrollment

314 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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