One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial
Starting soon · Not applicable
Conditions studied: Airway Extubation, Extubation Failure, Weaning Mechanical Ventilation
In brief
This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on T-piece. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions: 1. One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated. 2. Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.
Key facts
- Study ID
- NCT07324382
- Run by
- Hospital do Coracao
- People needed
- 4000
- Starts
- 2026-02-01
- Expected to finish
- 2030-02-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged > 18 years.
- Admitted to the intensive care unit (surgical or medical).
- With endotracheal intubation.
- Mechanical ventilation for more than 72 hours.
- Who underwent successful spontaneous breathing trial (according to the study protocol) and is considered able to be extubated.
You may not qualify if…
- Patients unable to obey commands.
- With non-planned extubation.
- Neuromuscular disease and cervical spinal cord injury.
- Tracheostomy.
- Contraindication for cardiopulmonary resuscitation or reintubation.
- Terminal extubation.
- Lack of informed consent.
- Previously included in the trial.
Full record on ClinicalTrials.gov
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