Skip to main content
OpenTrials
Completed

NCT Number: NCT06301867

Preventing Failed Extubations

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Extubated in participating ICU during study period

Exclusion criteria

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

Treatment and study plan

Plateau Pressure

Diagnostic Test

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

Primary outcomes

  1. Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility

    Time frame: Day 0

    Feasibility is defined as 95% of patients having had a plateau pressure measured prior to extubation.

Secondary outcomes

  1. Percentage of patients who were reintubated prior to hospital discharge

    Time frame: Day 0 to Day 90

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Preventing Failed Extubations Cohort Study

Acronym: PreFIX

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.