Mechanical VentilationWEAN-FAILNCT06683781
Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients
An observational study of Mechanical Ventilation and Weaning Failure, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Mechanical ventilation (MV) is essential in managing acute respiratory failure. Its duration is a crucial aspect since both, unnecessary prolongation and premature withdrawal have deleterious effects on patient outcomes in the ICU. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mechanical Ventilation, Weaning Failure, Weaning Failure of Mechanical Ventilation
- How many people
- 1,077 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Dec 2024to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients who required MV and underwent a weaning process in the ICU admitted up to July 1, 2024, whose MV settings and monitoring data are complete in their medical records.
Who may be able to join
- Over 18 years
- MV for at least 48 hours, regardless of the cause of onset
- Undergone at least one extubation, regardless of the outcome
- At least one spontaneous breathing trial (SBT) during their ICU stay, regardless of the outcome
Who cannot join
- MV records containing incorrect or inconsistent data
- did not have adequate or continuous monitoring during the weaning process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Damián E Steinberg, RT contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, 1199
Emilio M Steinberg, RT, +54 11 4959-0200 ext. 7528, emilio.steinberg@hospitalitaliano.org.ar
Mariano Setten, RT
About this study
Official title: Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients: A Retrospective Study
Mechanical ventilation (MV) is essential in managing acute respiratory failure. Its duration is a crucial aspect since both, unnecessary prolongation and premature withdrawal have deleterious effects on patient outcomes in the ICU. The process of weaning refers to the set of procedures and evaluations carried out to discontinue MV. Regardless of the definition used, within the population undergoing weaning, there is a group of patients who successfully pass the daily screening but fail the spontaneous breathing trial (SBT) or the separate attempt (SA). In Argentina, this figure is 39.5%, and 31.4% in patients with COVID-19. On the other hand, another group of patients successfully passes the SA, is extubated, but fails in post-extubation. This failure rate varies in the literature, ranging from approximately 10 to 20%. In our country, this figure is 16% in the general population and rises to 29.7% in COVID-19 patients. Additionally, this population is divided into those who cannot tolerate ventilation without an artificial airway due to upper airway patency issues (such as laryngeal edema), i.e., "airway failure," and those who experience acute respiratory failure. In 2023, the WEAN SAFE study reported novel findings regarding variables associated with weaning failure. In multivariable analysis, it was found that the MV settings and monitoring variables at the time of the first SBT - respiratory rate, positive end-expiratory pressure (PEEP), dynamic airway pressure difference (peak pressure (Ppeak) minus PEEP) on the day of the SA - were associated with weaning failure. In this context, the investigators will conduct a retrospective cohort study, whose primary objective will be to assess which MV settings and monitoring variables are associated with weaning failure.
Primary Objective To determine if there are any MV settings or monitoring variables that are associated with extubation failure.
Secondary Objective To determine if there are any MV settings or monitoring variables that are associated with failure in the first SBT.
- Conditions
- Mechanical Ventilation, Weaning Failure, Weaning Failure of Mechanical Ventilation, Intensive Care Unit ICU
- Keywords
- weaning failure, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with extubation failure
Need for reintubation within the first 7 days after the removal of the endotracheal tube, regardless of the cause that precipitates it.
Measured: 7 days
Cause of reintubation
Reason that precipitates the need for reinsertion of the endotracheal tube.
Measured: 7 days
Secondary outcomes (1)
Spontaneous breathing trial failure
Rate of restoring invasive MV due to objective or subjective signs.
Measured: Immediately after spontaneous breathing trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,077 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMILIO MARTIN STEINBERG, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683781
- Sponsor's protocol ID
- 7221
- Acronym
- WEAN-FAIL
- Status last verified
- Mar 2025
- First submitted
- 8 Nov 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steinberg E, Garegnani LI, Steinberg D, Manias E, Lovazzano P, Mazzini L, Nieto J, Lavitola N, Gimenez ML, Setten M. Ventilator Settings and Monitoring Variables Associated with Extubation Failure in Critically Ill Patients: A Retrospective Cohort Study. Crit Care Sci. 2026 May 11;38:e20260327. doi: 10.62675/2965-2774.20260327. eCollection 2026.
PubMed 42138867
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06683781
- Acronym / sponsor ID
- WEAN-FAIL / 7221
- Conditions
- Mechanical Ventilation, Weaning Failure, Weaning Failure of Mechanical Ventilation, Intensive Care Unit ICU
- Keywords
- weaning failure, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,077 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical ventilation (MV) is essential in managing acute respiratory failure. Its duration is a crucial aspect since both, unnecessary prolongation and premature withdrawal have deleterious effects on patient outcomes in the ICU. The process of weaning refers to the set of procedures and evaluations carried out to discontinue MV. Regardless of the definition used, within the population undergoing weaning, there is a group of patients who successfully pass the daily screening but fail the spontaneous breathing trial (SBT) or the separate attempt (SA). In Argentina, this figure is 39.5%, and 31.4% in patients with COVID-19. On the other hand, another group of patients successfully passes the SA, is extubated, but fails in post-extubation. This failure rate varies in the literature, ranging from approximately 10 to 20%. In our country, this figure is 16% in the general population and rises to 29.7% in COVID-19 patients. Additionally, this population is divided into those who cannot tolerate ventilation without an artificial airway due to upper airway patency issues (such as laryngeal edema), i.e., "airway failure," and those who experience acute respiratory failure. In 2023, the WEAN SAFE study reported novel findings regarding variables associated with weaning failure. In multivariable analysis, it was found that the MV settings and monitoring variables at the time of the first SBT - respiratory rate, positive end-expiratory pressure (PEEP), dynamic airway pressure difference (peak pressure (Ppeak) minus PEEP) on the day of the SA - were associated with weaning failure. In this context, the investigators will conduct a retrospective cohort study, whose primary objective will be to assess which MV settings and monitoring variables are associated with weaning failure.
Primary Objective To determine if there are any MV settings or monitoring variables that are associated with extubation failure.
Secondary Objective To determine if there are any MV settings or monitoring variables that are associated with failure in the first SBT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients who required MV and underwent a weaning process in the ICU admitted up to July 1, 2024, whose MV settings and monitoring data are complete in their medical records.
Key inclusion criteria (4 listed)
- Over 18 years
- MV for at least 48 hours, regardless of the cause of onset
- Undergone at least one extubation, regardless of the outcome
- At least one spontaneous breathing trial (SBT) during their ICU stay, regardless of the outcome
Key exclusion criteria (2 listed)
- MV records containing incorrect or inconsistent data
- did not have adequate or continuous monitoring during the weaning process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with extubation failure
Time frame: 7 days
Need for reintubation within the first 7 days after the removal of the endotracheal tube, regardless of the cause that precipitates it.
Cause of reintubation
Time frame: 7 days
Reason that precipitates the need for reinsertion of the endotracheal tube.
1 secondary outcome
Spontaneous breathing trial failure
Time frame: Immediately after spontaneous breathing trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 42138867Steinberg E, Garegnani LI, Steinberg D, Manias E, Lovazzano P, Mazzini L, Nieto J, Lavitola N, Gimenez ML, Setten M. Ventilator Settings and Monitoring Variables Associated with Extubation Failure in Critically Ill Patients: A Retrospective Cohort Study. Crit Care Sci. 2026 May 11;38:e20260327. doi: 10.62675/2965-2774.20260327. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
DIAPHRAGM STRENGTH AND LUNG VOLUMES
Mechanical Ventilation
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damián E Steinberg, RT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Weaning Failure, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilio M Steinberg, RT (+54 11 4959-0200 ext. 7528, emilio.steinberg@hiba.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with extubation failure (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.