Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial)

Abstract

Introduction Cardiac catheterisation procedures are typically performed with local anaesthetic and proceduralist guided sedation. Various fasting regimens are routinely implemented prior to these procedures, noting an absence of prospective evidence, aiming to reduce aspiration risk. However, there are additional risks from fasting including patient discomfort, intravascular volume depletion, stimulus for neuro-cardiogenic syncope, glycaemic outcomes, and unnecessary fasting for delayed/cancelled procedures. Methods and Analysis This is an investigator-initiated, multicentre, randomised trial with a prospective, open-label, blinded endpoint (PROBE) assessment based in New South Wales, Australia. Patients will be randomised 1:1 to fasting (6 hours solid food, and 2 hours clear liquids) or to no fasting requirements. The primary outcome will be a composite of hypotension, hyperglycaemia, hypoglycaemia, and aspiration pneumonia. Secondary outcomes will include patient satisfaction, contrast induced nephropathy, new intensive care admission, new non-invasive or invasive ventilation requirement post procedure, and 30-day mortality and readmission. Ethics and Dissemination Ethics approval is confirmed via the Hunter New England Research Ethics Committee. The trial has been registered on the Australia New Zealand Clinical Trials Registry (ACTRN12622001455752). De-identified patient level data will be available to researchers who provide sound analysis proposals.