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Preventing Failed Extubations

Preventing Failed Extubations Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06301867
Acronym
PreFIX
Enrollment
248
Registered
2024-03-08
Start date
2024-03-01
Completion date
2024-11-05
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Weaning Failure

Brief summary

More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure.

Detailed description

Spontaneous breathing trials (SBTs) with pressure-support ventilation are commonly used to determine if mechanically ventilated patients are ready for extubation. However, 10-25% of all patients who pass a spontaneous breathing trial and are extubated will require re-intubation . Extubation failure is associated with an up to 50% increased risk of death independent of other risk factors and patient characteristics . Currently proposed methods for identifying patients who pass an SBT but are at high risk of reintubation perform poorly when applied in a real-world setting . Thus, there is a critical need to develop new methodologies for identifying patients at high risk for extubation failure. Respiratory system mechanics, such as compliance, driving pressure, and plateau pressure, can identify patients at risk of poor outcomes, including prolonged mechanical ventilation and death. However, respiratory system mechanics are not commonly measured during spontaneous breathing trials, and the relationship between respiratory mechanics during an SBT and extubation failure is not known. This is due in part to long-standing concerns that accurate measurements of plateau pressures, and thus driving pressures and compliance, cannot be made in spontaneously breathing patients. The objective of this study is to determine if respiratory compliance measured during a spontaneous breathing trial is a feasible method for identifying patients at increased risk of extubation failure.

Interventions

DIAGNOSTIC_TESTPlateau Pressure

Plateau pressure will be measured on all patients in the participating intensive care units prior to extubation.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years

Inclusion criteria

* Extubated in participating ICU during study period

Exclusion criteria

* Previously extubated during hospitaliztion * Extubation as part of transitioning to comfort measures

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibilityDay 0Feasibility is defined as 95% of patients having had a plateau pressure measured prior to extubation.

Secondary

MeasureTime frame
Percentage of patients who were reintubated prior to hospital dischargeDay 0 to Day 90

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026