Protocol for a randomised controlled trial: reducing reintubation among high-risk cardiac surgery patients with high-flow nasal cannula (I-CAN).

ABSTRACT

INTRODUCTION: Heated, humidified, high-flow nasal cannula oxygen therapy has been used as a therapy for hypoxic respiratory failure in numerous clinical settings. To date, limited data exist to guide appropriate use following cardiac surgery, particularly among patients at risk for experiencing reintubation. We hypothesised that postextubation treatment with high-flow nasal cannula would decrease the all-cause reintubation rate within the 48 hours following initial extubation, compared with usual care. METHODS AND ANALYSIS: Adult patients undergoing cardiac surgery (open surgery on the heart or thoracic aorta) will be automatically enrolled, randomised and allocated to one of two treatment arms in a pragmatic randomised controlled trial at the time of initial extubation. The two treatment arms are administration of heated, humidified, high-flow nasal cannula oxygen postextubation and usual care (treatment at the discretion of the treating provider). The primary outcome will be all-cause reintubation within 48 hours of initial extubation. Secondary outcomes include all-cause 30-day mortality, hospital length of stay, intensive care unit length of stay and ventilator-free days. Interaction analyses will be conducted to assess the differential impact of the intervention within strata of predicted risk of reintubation, calculated according to our previously published and validated prognostic model. ETHICS AND DISSEMINATION Vanderbilt University Medical Center IRB approval, 15 March 2021 with waiver of written informed consent. Plan for publication of study protocol prior to study completion, as well as publication of results. TRIAL REGISTRATION NUMBER clinicaltrials.gov, NCT04782817 submitted 25 February 2021. DATE OF PROTOCOL 29 August 2022. Version 2.0.