Preventing Failed Extubations (PreFIX)

Duke University

Status: Enrolling

Conditions: Weaning Failure; Mechanical Ventilation Complication

Treatments: Diagnostic Test: Plateau Pressure

Study type: Observational

Funder types: Other

Identifiers

NCT06301867

Pro00113877

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Extubated in participating ICU during study period

Exclusion criteria

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

Trial design

250 participants in 1 patient group

Extubated Patients

Description:

All patients receiving mechanical ventilation who are extubated in the intensive care units during the study period.

Treatment:

Diagnostic Test: Plateau Pressure