Preventing Failed Extubations

Mechanical Ventilation Complication Clinical Trial

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Official title:

Preventing Failed Extubations Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301867
• Other study ID #: Pro00113877
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: Elias H. Pratt, MD
• Phone: 9196848111
• Email: elias.pratt[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Extubated in participating ICU during study period

Exclusion Criteria:

• Previously extubated during hospitaliztion

• Extubation as part of transitioning to comfort measures

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Weaning Failure

Intervention

Diagnostic Test:
• Plateau Pressure
Plateau pressure will be measured on all patients in the participating intensive care units prior to extubation.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility	Feasibility is defined as 95% of patients having had a plateau pressure measured prior to extubation.	Day 0
Secondary	Percentage of patients who were reintubated prior to hospital discharge		Day 0 to Day 90