Direct extubation versus extubation after a spontaneous breathing trial in low-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label study compares two weaning strategies for adults on mechanical ventilation who meet readiness-to-wean criteria and are considered at low risk for extubation failure. One arm uses a direct extubation approach, while the other requires a successful spontaneous breathing trial before extubation. The primary endpoint is the proportion of patients extubated successfully within 24 hours after randomization. The study aims to determine if omitting the SBT can increase timely extubation without increasing failure. Safety considerations include avoiding unnecessary delays or extubation failure in this specific low-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Pitié Salpêtrière
  Paris, France Recruiting

Study contacts

• Principal investigator: Martin DRES, Pr — Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
• Study coordinator: Martin DRES, Pr
• Email: martin.dres@aphp.fr
• Phone: 01 42 16 77 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.