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NCT Number: NCT07019636

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

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).

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Respiratory rate < 35 cycles per minute
  • SpO2 >90% with FiO2<40% and PEEP<8 cmH2O
  • RASS score between -2 and +2 with low level or no sedatives
  • No need or low doses of vasopressors
  • 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

Treatment and study plan

Weaning strategy with direct extubation (no spontaneous breathing trial)

Procedure

Patients will be extubated within the 60 minutes following randomization

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

Primary outcomes

  1. Proportion of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.

    Time frame: From Day 1 to Day 3

    The rate of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.

Secondary outcomes

  1. Occurrence of post extubation acute respiratory failure

    Time frame: Within 28 days after randomization

    Rate of post extubation acute respiratory failure defined by the persistence of more than 30 minutes of at least two predefined criteria

  2. Occurrence of reintubation

    Time frame: Within 28 days after randomization

    Rate of of reintubation with predefined criteria

  3. Unplanned use of non-invasive ventilation or high flow nasal oxygen

    Time frame: Within 28 days after randomization

    Rate of unplanned use of non-invasive ventilation or high flow nasal oxygen

  4. Duration of weaning process from randomization until successful extubation

    Time frame: Within 28 days after randomization

    Number of days from randomization until successful extubation

  5. Total duration of invasive mechanical ventilation from intubation until successful extubation

    Time frame: Within 28 days after randomization

    Total number of days of invasive mechanical ventilation from intubation until successful extubation

  6. Number of Ventilator Free Days between randomization until Day 28

    Time frame: Within 28 days after randomization

    Number of days without the ventilator and alive from randomization until Day 28

  7. Occurrence of ventilator acquired pneumonia

    Time frame: Within 28 days after randomization

    Ventilator acquired pneumonia will be defined by quantitative distal bronchoalveolar lavage cultures growing ≥104cfu/mL

  8. Length of stay in the ICU and hospital stay

    Time frame: Within 28 days after randomization

    Number of days in the ICU and in the hospital

  9. ICU and hospital mortality

    Time frame: Within 28 days after randomization

    Proportion of patients who died in the ICU and in the hospital

  10. Day 28 mortality

    Time frame: Within 28 days after randomization

    Rate of patients who died at day 28 after randomization

  11. Cumulative incidence of successful extubation over time

    Time frame: Within 28 days after randomization

    Probability of being successfully extubated from randomization until day 28

  12. Duration between randomization and SBT trial

    Time frame: Within 28 days after randomization

    The time between randomization and the onset of the SBT, minutes

  13. Barriers to extubation: logistical, timing, family or patient.

    Time frame: Within 28 days after randomization

    Open

  14. Duration between extubation decision and extubation

    Time frame: Within 28 days after randomization

    Time between extubation decision and extubation, minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Martin DRES, Pr

CONTACT

[email protected]

01 42 16 77 97

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: T-REX

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 13, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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