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One-Hour Positive Pressure Ventilation After a Pressure Support Spontaneous Breathing Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Start date: Feb 2026 to Jan 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Notable Primary endpoint revised
    • Start date: Jan 2026 to Feb 2026
    • Secondary endpoints revised (3)
    • Study title shortened, about 4 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 pressure support. 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.
Trial Details
NCT Number NCT07324460
Lead Sponsor Hospital do Coracao
Conditions
(from sponsor)
Airway Extubation, Weaning Mechanical Ventilation, Extubation Failure
Enrollment 4,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov