Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two methods of helping patients in the ICU breathe on their own after being on a ventilator. One method involves a "spontaneous breathing trial," where patients are given a chance to breathe without the ventilator for a short period before being taken off completely. The other method, called "direct extubation," means removing the ventilator without that trial first. The goal is to see which method is more successful in helping patients breathe on their own within 24 hours.

To be eligible for this trial, participants need to be adults aged 18 to 65, have been on a ventilator for more than 24 hours but less than four days, and meet specific health criteria, such as having a stable breathing rate and good oxygen levels. Participants will be randomly assigned to either of the two methods. It's important to note that some patients may not be eligible if they have certain health conditions or complications. Overall, this trial aims to find the best way to help patients transition off ventilators safely and effectively.

Gender

ALL

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