ONE-HOUR POSITIVE PRESSURE VENTILATION AFTER A T-PIECE SPONTANEOUS BREATHING TRIAL: A RANDOMIZED CLINICAL TRIAL (GS-Wean Tpiece)

Hospital do Coracao

Status: Not yet enrolling

Conditions: Airway Extubation; Weaning Mechanical Ventilation; Extubation Failure

Treatments: Other: Immediate extubation; Other: One-hour positive pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07324382

GS-Wean: T-piece SBT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,000 participants in 2 patient groups

One-hour positive pressure ventilation

Experimental group

Treatment:

Other: One-hour positive pressure ventilation

Immediate extubation

Active Comparator group

Treatment:

Other: Immediate extubation