Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
NCT Number: NCT04782817
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37212, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48 hours
Reintubation within 48 hours of initial extubation after cardiac surgery
Time frame: 72 hours
Reintubation within 72 hours of initial extubation after cardiac surgery
Time frame: hospital discharge (usually 14 days)
Reintubation at any time during hospitalization after cardiac surgery
Time frame: 30 days post surgery
Time frame: 8 days
Time frame: 3 days
Intensive Care Unit length of stay after cardiac surgery
Time frame: 1 day
Ventilator-free days during hospitalization after cardiac surgery
Time frame: 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
Time frame: 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
Vanderbilt University Medical Center
Other
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.
NCT07730918
Hemodynamic Instability During Anesthesia, Induction Anesthesia
Zhangjiagang, Jiangsu, China
View Trial DetailsNCT05825560
Intubation
Nîmes, Gard, France
View Trial DetailsNCT05719194
Intubation, Mechanical Ventilation
Bordeaux, France
View Trial DetailsNCT07125495
Infection, Infections
Istanbul, Turkey (Türkiye)
View Trial Details