The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the all-cause 48-hour reintubation rate (extubation failure within 48 hours of initial extubation).
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 along with other therapies, including: 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. This prospective, randomized, pragmatic clinical trial will compare HFNC to provider choice of usual 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,568
Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates.
Participants will receive order set with provider choice of standard care therapy.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Reintubation within 48 hours of extubation
Reintubation within 48 hours of initial extubation after cardiac surgery
Time frame: 48 hours
Reintubation within 72 hours of extubation
Reintubation within 72 hours of initial extubation after cardiac surgery
Time frame: 72 hours
Reintubation after cardiac surgery
Reintubation at any time during hospitalization after cardiac surgery
Time frame: hospital discharge (usually 14 days)
All cause mortality
Time frame: 30 days post surgery
Hospital length of stay
Time frame: 8 days
Intensive Care Unit length of stay
Intensive Care Unit length of stay after cardiac surgery
Time frame: 3 days
Ventilator-free days
Ventilator-free days during hospitalization after cardiac surgery
Time frame: 1 day
In-hospital mortality
Mortality which occurs in-hospital following surgery, up to the time of hospital discharge
Time frame: Until hospital discharge, which usually occurs in approximately 8 days in the majority of patients
Adjusted reintubation rate
Adjusted reintubation rate within 48 hours of initial extubation, if adjustment is needed based on clinically relevant imbalance in baseline characteristics between groups
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Time frame: 48 hours