Cardiovascular Surgical Procedure, Intubation
Conditions
Keywords
High-flow nasal cannula oxygen therapy, Reintubation
Brief summary
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).
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 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.
Interventions
OTHERRecommendation for high flow nasal cannula oxygen therapy order set
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.
OTHERProvider choice standard care order set
Participants will receive order set with provider choice of standard care therapy.
Sponsors
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Undergoing cardiac surgery, defined as a documented surgical service of "cardiac surgery" in the electronic health record, performed in the main operating rooms at Vanderbilt University Medical Center * Admitted to the cardiovascular intensive care unit postoperatively with an endotracheal tube in place and mechanically ventilated * Surgery duration (documented time between "Anesthesia start" and "Anesthesia stop" in the EHR) of at least 180 minutes * Received an order to be extubated by a treating provider o Patients who meet all other criteria but do not receive an order to extubate will be randomized but not enrolled
Exclusion criteria
• Patient does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation within 48 hours of extubation | 48 hours | Reintubation within 48 hours of initial extubation after cardiac surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation within 72 hours of extubation | 72 hours | Reintubation within 72 hours of initial extubation after cardiac surgery |
| Reintubation after cardiac surgery | hospital discharge (usually 14 days) | Reintubation at any time during hospitalization after cardiac surgery |
| All cause mortality | 30 days post surgery | — |
| Hospital length of stay | 8 days | — |
| Intensive Care Unit length of stay | 3 days | Intensive Care Unit length of stay after cardiac surgery |
| Ventilator-free days | 1 day | Ventilator-free days during hospitalization after cardiac surgery |
| In-hospital mortality | Until hospital discharge, which usually occurs in approximately 8 days in the majority of patients | Mortality which occurs in-hospital following surgery, up to the time of hospital discharge |
| Adjusted reintubation rate | 48 hours | Adjusted reintubation rate within 48 hours of initial extubation, if adjustment is needed based on clinically relevant imbalance in baseline characteristics between groups |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert E Freundlich, MD
Vanderbilt University Medical Center
Outcome results
None listed