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Clinical Trial Summary

The purpose of this study is to compare reintubation rates and outcomes of patients treated with high-flow nasal canula oxygen therapy (HFNC) and patients treated with provider choice of standard care.


Clinical Trial Description

HFNC may be employed as a strategy to facilitate early extubation and prevent reintubation of patients following cardiac surgery. HFNC is routinely employed by providers in the cardiovascular intensive care unit and is selectively employed in patients who are judged by the provider to be high-risk, along with other therapies: bi-level positive airway pressure, non-rebreather masks, among others. Currently, no high-quality clinical data exist to demonstrate that HFNC may decrease the risk of reintubation in this critically-ill adult population. To guide a future, larger, multicenter randomized controlled pragmatic clinical trial, a pilot study in a single, high-volume cardiovascular intensive care unit will be performed. The prospective, randomized, pragmatic pilot clinical trial will compare HFNC to provider choice of standard care in these high-risk patients. Randomization will occur at the time that the patient is deemed ready for extubation by the attending physician in the cardiovascular intensive care unit. Through randomization, patients will be assigned one of two physician order sets in the electronic medical record system: standard order set with or without recommendation for the use of HFNC. Reintubation and outcome data will be collected until patient discharge. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04782817
Study type Interventional
Source Vanderbilt University Medical Center
Contact Robert E Freundlich, MD
Phone (615)936-6608
Email robert.e.freundlich@vumc.org
Status Recruiting
Phase N/A
Start date November 1, 2021
Completion date December 1, 2025

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