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One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial

Study acronym: GS-Wean Tpiece
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Feb 2026 to Jan 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Primary endpoint revised
    • Start date: Jan 2026 to Feb 2026
    • Secondary endpoints revised (3)
    • Study title shortened, about 4 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT07324382
Lead Sponsor Hospital do Coracao
Conditions
(from sponsor)		 Airway Extubation, Extubation Failure, Weaning Mechanical Ventilation
Enrollment 4,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov