Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients (WEAN-FAIL)

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.

Study Overview

• Status: Recruiting
• Conditions: Weaning Failure; Mechanical Ventilation; Weaning Failure of Mechanical Ventilation; Intensive Care Unit ICU

• Study Type: Observational
• Enrollment (Estimated): 1077

Contacts and Locations

• Study Contact: Name: Emilio M Steinberg, RT; Phone Number: 7528 +54 11 4959-0200; Email: emilio.steinberg@hiba.org.ar
• Study Contact Backup: Name: Damián E Steinberg, RT; Email: damianedstein@gmail.com

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aires, Argentina, 1199
    • Recruiting
    • Hospital Italiano de Buenos Aires
    • Contact: Emilio M Steinberg, RT; Phone Number: 7528 +54 11 4959-0200; Email: emilio.steinberg@hospitalitaliano.org.ar
    • Sub-Investigator: Mariano Setten, RT
    • Sub-Investigator: Luis I Garegnani, RT
    • Sub-Investigator: Damián E Steinberg, RT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• MV records containing incorrect or inconsistent data
• did not have adequate or continuous monitoring during the weaning process

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mechanically ventilated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days
Cause of reintubation	Reason that precipitates the need for reinsertion of the endotracheal tube.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous breathing trial failure	Rate of restoring invasive MV due to objective or subjective signs.	Immediately after spontaneous breathing trial

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; weaning failure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 7221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No