Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782817
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2021-03-01
Brief Title:
Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None