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

February 11, 2026 updated by: Hospital do Coracao

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One-hour positive pressure ventilation
Other: One-hour positive pressure ventilation
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.
Active Comparator: Immediate extubation
Other: Immediate extubation
The patient will be extubated immediately (up to 10 minutes) after the success of the spontaneous breathing trial.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Extubation Failure Within 7 Days
Time Frame: 7 days (from randomization through Day 7 after randomization)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ventilator-Free Days Through Day 28
Time Frame: 28 days (from randomization through Day 28 after randomization)
Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation from randomization through Day 28 after randomization. If a patient dies before day 28, the ventilator-free days will be counted as zero. If a patient is reintubated and returns to mechanical ventilation and later is extubated again and remains in unassisted breathing until day 28, the ventilator-free days will be counted from the end of the last period of assisted breathing until day 28. An invasive mechanical ventilation period of less than 24 hours for surgical purposes will count as 1 ventilator-free day. Patients discharged from the hospital in unassisted breathing before 28 days will be considered alive and free from mechanical ventilation for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed up until day 28 to assess this outcome.
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)
Hospital-free days are defined as the number of days alive and out of the hospital from randomization through Day 28 after randomization. If a patient dies before day 28, the hospital-free days will be counted as zero. Patients discharged from the hospital in unassisted breathing before 28 days will be considered alive and free from hospital for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed through day 28 to ascertain this outcome.
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)
All-cause mortality from randomization through day 28
28 days (from randomization through Day 28 after randomization)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ventilatory Support-Free Days Through Day 28
Time Frame: 28 days (from randomization through Day 28 after randomization)
Ventilatory support-free days are defined as the number of days alive and free from any ventilatory support (invasive or noninvasive) from randomization through day 28. Any use of invasive mechanical ventilation for any duration during a calendar day will count as 1 day with ventilatory support (i.e., not free). Use of noninvasive ventilatory support (noninvasive ventilation or high-flow nasal cannula) for ≥6 hours in any calendar day will count as 1 day with ventilatory support. Participants who die before day 28 will be assigned 0 ventilatory support-free days. If reintubation occurs and the participant later achieves unassisted spontaneous breathing again, ventilatory support-free days will be counted from the end of the last assisted-breathing period through day 28, provided the participant remains alive and free from ventilatory support.
28 days (from randomization through Day 28 after randomization)
Number of Participants With Extubation Failure Within 2 Days
Time Frame: 2 days (from randomization through Day 2 after randomization)
Extubation failure is defined as a composite endpoint of reintubation or death within 2 days after randomization
2 days (from randomization through Day 2 after randomization)
Number of Participants With Death or Reintubation Within 28 Days
Time Frame: 28 days (from randomization through Day 28 after randomization)
Composite endpoint of reintubation or death within 28 days after randomization
28 days (from randomization through Day 28 after randomization)
Intensive Care Unit-Free Days Through Day 28
Time Frame: 28 days (from randomization through Day 28 after randomization)
ICU-free days are defined as the number of days alive and out of the intensive care unit from randomization through day 28. If a patient dies before day 28, the ICU-free days will be counted as zero. Patients discharged from the hospital in unassisted breathing before 28 days will be considered as alive and free from ICU for the remaining days up to 28 days. Patients transferred to another hospital or healthcare unit will be followed up until day 28 to assess this outcome.
28 days (from randomization through Day 28 after randomization)
Number of Participants Who Died in the Intensive Care Unit
Time Frame: From randomization to ICU discharge, up to 90 days
All-cause mortality occurring from randomization until ICU discharge (death before ICU discharge)
From randomization to ICU discharge, up to 90 days
Number of Participants Who Died in the Hospital
Time Frame: From randomization to hospital discharge, up to 90 days
All-cause mortality occurring from randomization until hospital discharge (death before hospital discharge)
From randomization to hospital discharge, up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital do Coracao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-Wean: PSV SBT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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