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

NCT07324382 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2026-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Airway Extubation
  • Extubation Failure
  • Weaning Mechanical Ventilation

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.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2029-12-31
Completion
2030-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07324382 on ClinicalTrials.gov