None listed
Conditions
Brief summary
Fasting is standard of care prior to catheter laboratory procedures. The purpose of this is to reduce the risk of aspiration events during procedural sedation. Generally, this involves 6 hours of solid food fasting with 2 hours of clear fluid fasting. Currently there are limited prospective data reviewing the utility of fasting versus no fasting prior to catheterisation procedures. Recently the CHOW NOW study based in America performed a randomised control trial assessing this question. They demonstrated non-inferiority of no-fasting with a pre-specified margin of 5.9%. We wish to assess the non-inferiority of no fasting for catheterisation laboratory procedures in a multicentre trial with a narrower non-inferiority margin of 3%. Fasting prior to procedures may be associated with patient discomfort and distress. In addition, there are some populations where oral intake is important to prevent adverse events. Examples include those with chronic kidney disease where dehydration, potentially precipitated by fasting, associates with increased risk of contrast induced nephropathy. Moreover, patients are frequently cancelled due to lack of fasting. Relinquishing prerequisites for fasting prior to procedures may assist in providing expedited patient care and reduce adverse events related to underlying disease. The main risk associated with no fasting is that of aspiration pneumonia. In the CHOW NOW study, only 0.7% of the non-fasting group experienced this adverse event. This is an uncommon and treatable complication. Risks of fasting (dehydration, hypotension, hypoglycaemia, contrast induced nephropathy, patient discomfort) may outweigh the benefits in preventing the uncommon event of aspiration pneumonia. Though a randomised trial has already been performed, the American Society of Anaesthesiologists has requested more data prior to the acceptance of no fasting before simple catheterisation laboratory procedures.
Interventions
No fasting requirements of solids or liquids.
Patients in the interventional group are allowed to eat and drink as they please.
Patients will be questioned as to the last time of food and drink intake prior to the procedure.
This will be for pacemaker and defibrillator procedures as well as diagnostic and interventional cardiac angiography procedures.
Structural heart disease interventions, requirement for calcium modification therapy, electrophysiology studies and cardiac resynchronisatio
No fasting requirements of solids or liquids. Patients in the interventional group are allowed to eat and drink as they please. Patients will be questioned as to the last time of food and drink intake prior to the procedure. This will be for pacemaker and defibrillator procedures as well as diagnostic and interventional cardiac angiography procedures. Structural heart disease interventions, requirement for calcium modification therapy, electrophysiology studies and cardiac resynchronisation therapy procedures will be excluded
Sponsors
John Hunter Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged over 18 years of age. • Are referred for catheterisation laboratory procedures including coronary angiography, percutaneous coronary intervention and device implantation or replacement (pacemakers and defibrillators).
Exclusion criteria
• Pregnant or breastfeeding females. • Inability to provide informed consent. • Requirement for a general anaesthetic. • Complex catheterisation laboratory interventions o Chronic total occlusion, rotational atherectomy, shockwave lithotripsy or planned mechanical support (IABP/Impella) o Balloon aortic valvuloplasty, transcatheter aortic valve implantation, mitral valve clipping o Electrophysiologic studies – diagnostic and ablation o Biventricular Cardiac Resynchronisation Therapy
Outcome results
None listed