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Title: Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial)
Authors: Ferreira, David;Hardy, Jack;Meere, William ;Butel-Simoes, Lloyd;McGee, Michael;Whitehead, Nicholas;Healey, Paul;Ford, Tom ;Oldmeadow, Christopher;Attia, John;Wilsmore, Bradley ;Collins, Nicholas;Boyle, Andrew
Affliation: Central Coast Local Health District
Gosford Hospital
Issue Date: Nov-2023
Source: 3(6):oead111
Journal title: European Heart Journal
Department: Cardiology
Abstract: Cardiac catheterization procedures are typically performed with local anaesthetic and proceduralist guided sedation. Various fasting regimens are routinely implemented prior to these procedures, noting the 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. This is an investigator-initiated, multicentre, randomized trial with a prospective, open-label, blinded endpoint (PROBE) assessment based in New South Wales, Australia. Patients will be randomized 1:1 to fasting (6 h solid food and 2 h 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. This is a pragmatic and clinically relevant randomised trial designed to compare fasting verse no fasting prior to cardiac catheterisation procedures. Routine fasting may not reduce peri-procedural adverse events in this setting.
DOI: 10.1093/ehjopen/oead111
Publicaton type: Journal Article
Keywords: Cardiology
Cardiovascular Disease
Study or Trial: Multicentre Studies
Appears in Collections:Health Service Research

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