Preventing Failed Extubations

Completed

• Conditions: Mechanical Ventilation Complication; Weaning Failure
• Interventions: Diagnostic Test: Plateau Pressure

• Registration Number: NCT06301867
• Lead Sponsor: Duke University

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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-08
• Primary Completion: 2024-07-21
• Study Completion: 2024-11-05
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• Extubated in participating ICU during study period

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extubated Patients	Plateau Pressure	All patients receiving mechanical ventilation who are extubated in the intensive care units during the study period.

Primary Outcome Measures

Name	Time	Method
Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility	Day 0	Feasibility is defined as 95% of patients having had a plateau pressure measured prior to extubation.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who were reintubated prior to hospital discharge	Day 0 to Day 90

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States