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Not yet recruiting NCT07324382

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

No phase Interventional Airway Extubation Extubation Failure Weaning Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: One-hour positive pressure ventilation, Immediate extubation.
Who it may be relevant to
Registry conditions: Airway Extubation, Extubation Failure, Weaning Mechanical Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

One-Hour Positive Pressure Ventilation After a T-Piece Spontaneous Breathing Trial: A Randomized Clinical Trial

Overview

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.

Detailed description

Adaptive design for sample size. The study will include up to a maximum of 4.000 patients. First interim analysis will be performed after complete data is available for the first 500 eligible patients. The Bayesian logistic regression model will be adjusted to provide posterior probabilities that will be compared with threshold values to evaluate stopping decisions. Extensive simulations were conducted to develop and understand adaptive design performance, interim analysis timing, and decision criteria. The trial may be stopped early for efficacy or futility. Secondary outcomes will be analyzed with a gatekeeping procedure to preserve overall type I error at 0.05. Thus, the assessment of statistical significance of secondary outcomes will be performed only if the preceding outcome in the hierarchy met the threshold for statistical significance. No adjustment for multiple comparisons will be applied for analyses of tertiary outcomes and subgroups. Thus, these results should be interpreted as exploratory. Secondary outcomes tested in hierarchical order will be: (1) Mechanical ventilation free days within 28 days; (2) Hospital free days within 28 days; (3) Mortality within 28 days.

Interventions

  • Other 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.
  • Other Immediate extubation
    The patient is extubated immediately after the success of the spontaneous breathing trial.

Primary outcome measures

  • Number of Participants With Extubation Failure Within 7 Days [Time frame: 7 days (from randomization through Day 7 after randomization)]
Secondary outcome measures (3)
  • Ventilator-Free Days Through Day 28 [Time frame: 28 days (from randomization through Day 28 after randomization)]
  • Hospital-Free Days Through Day 28 [Time frame: 28 days (from randomization through Day 28 after randomization)]
  • Number of Participants Who Died Within 28 Days [Time frame: 28 days (from randomization through Day 28 after randomization)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07324382 · GS-Wean: T-piece SBT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗