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

NCT07324460 | Not Yet Recruiting DMC

• 1 other identifier: GS-Wean: PSV SBT
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Airway Extubation; Weaning Mechanical Ventilation; Extubation Failure

Keywords

Airway extubation; Weaning Mechanical Ventilation; Extubation failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Extubation Failure Within 7 Days

  Extubation failure is defined as a composite endpoint of reintubation or death within 7 days after randomization

  7 days (from randomization through Day 7 after randomization)

Secondary Outcomes (3)

• Ventilator-Free Days Through Day 28

  28 days (from randomization through Day 28 after randomization)

• Hospital-Free Days Through Day 28

  28 days (from randomization through Day 28 after randomization)

• Number of Participants Who Died Within 28 Days

  28 days (from randomization through Day 28 after randomization)

Other Outcomes (6)

• Ventilatory Support-Free Days Through Day 28

  28 days (from randomization through Day 28 after randomization)

• Number of Participants With Extubation Failure Within 2 Days

  2 days (from randomization through Day 2 after randomization)

• Number of Participants With Death or Reintubation Within 28 Days

  28 days (from randomization through Day 28 after randomization)

Study Arms (2)

One-hour positive pressure ventilation

EXPERIMENTAL

Other: One-hour positive pressure ventilation

Immediate extubation

ACTIVE COMPARATOR

Other: Immediate extubation

Interventions

One-hour positive pressure ventilation OTHER

As soon as the success of the spontaneous breathing trial is confirmed, the patient will be submitted to one-hour positive pressure ventilation using the previous ventilatory parameters and, afterwards, extubated.

One-hour positive pressure ventilation

Immediate extubation OTHER

The patient will be extubated immediately (up to 10 minutes) after the success of the spontaneous breathing trial.

Immediate extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Aline B Pereira

CONTACT

+55 (47) 99181-8400; linibp@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02