Pre-Procedural Fasting in Cardiac Intervention
Pre-Procedural Fasting in Cardiac Intervention
Traditionally, patients are kept nil-per-os (NPO) or nil-by-mouth (NBM) prior to invasive
 cardiac procedures. There exists neither clear evidence nor guidance about the benefits of
 this.

 The investigators aim to assess if there is a reduced incidence of vasovagal complications
 (primary outcome) and the combined incidence of aspiration pneumonia, change in eGFR,
 participant satisfaction if participants are not kept fasting.

 This (pilot) randomised control trial will have an intervention arm allowing participants to
 drink clear liquids freely up to 1 hour before the procedure versus keeping them
 traditionally NPO.

 240 patients will be randomised with 120 participants in each arm.
Introduction, background and justification for the study

 Patients are traditionally kept Nulla-Per-Os/Nil-By-Mouth (NPO/NBM) for 4-6 hours prior to
 cardiac procedures including: diagnostic coronary angiograms, right heart catheters,
 percutaneous coronary interventions and device therapies to minimize the risk of vomiting and
 pulmonary aspiration during sedation or general anesthesia. The risk of developing pulmonary
 aspiration is 0.0015 % following emergency coronary artery bypass (CABG) surgery in patients
 without pre-procedural fasting. There is currently no data available regarding the risk of
 aspiration during cardiac angiographic interventions, but the risk is likely lower than that
 of emergency CABG. Currently no North-American or European guidelines require patients to be
 fasted before cardiac procedures.

 The incidence of emergency CABG following cardiac catheterization is between 0.15 % to 0.4 %,
 whilst that of cardiac arrest is about 1%. In the subset of patients who develop cardiac
 arrest during elective cardiac catheterization or PCI, the incidence of pulmonary aspiration
 is low and similar between survivors and non-survivors (8.9% of patients who developed
 cardiac arrest).

 Unsurprisingly, patients admitted with acute MI undergoing Primary PCI (PPCI) are not fasted
 beforehand and the need for emergency intubation/CABG remains rare in these patients.

 A study has shown a rare occurrence of pulmonary aspiration in general anesthesia with a risk
 of 0.02% for elective and 0.1% for emergency procedures. In two randomized controlled trials,
 no case of pulmonary aspiration was reported despite the absence of pre-procedure fasting and
 use of Midazolam/Diazepam/etomidate.

 Similarly, in an observational study no patient developed pulmonary aspiration. A Cochrane
 review did not show an increased risk of pulmonary aspiration with shorter fluid fast. A
 review article did not report an increased risk of pulmonary aspiration in non-fasted
 patients in the emergency department. However, a prospective multicenter emergency-department
 study of 2623 patients revealed only one patient developed aspiration pneumonia following the
 use of sedation. There is current consensus in the anesthesia literature that it is safe for
 healthy individuals to drink clear fluids up to 2 hours before induction of general
 anesthesia. It is recommended that 2 hours fasting for clear fluids, 6 hours for solids and
 supports the concept of pre-operative oral nutrition using a special carbohydrate-rich
 beverage. On the other hand, coronary procedures require the use of intravenous contrast,
 which can precipitate acute renal impairment. It has been shown that proper hydration can
 reduce the risk of contrast-induced nephropathy. A review study suggests that the oral route
 is as effective as the intravenous route for volume expansion and reduction of
 contrast-induced acute kidney injury. A prospective study demonstrated that lack of fasting
 was not associated with a higher incidence of adverse events in children undergoing
 pre-procedural sedation in the emergency department. A recent clinical policy published by
 the American College of Emergency Physicians; has recommended (Level B), that procedural
 sedations in emergency departments should not be delayed based on fasting status.

 Similarly, a recent retrospective study of 1900 patients in UK, demonstrated that patients do
 not need to be NPO prior to Percutaneous Coronary Intervention (PCI). Another study has
 demonstrated that reduced gastric pH (<2.0) and increased gastric volumes predisposed to
 pulmonary aspiration. Invasive procedures such as angiography and angioplasty both are
 associated with a small risk of adverse events. One such adverse event is vasovagal reaction
 which occurs in 3-4% of patients and may be exacerbated by depletion of volume as seen in the
 fasted state .

 Current status at the University Health Network UHN policy requires patients to fast for both
 solids and liquids for a minimum of 4 hours before cardiac catheterization.

 The investigators explore a fasting protocol that is different from current UHN policy

 Introduction, background and justification for the study:

 UHN policy requires patients to fast for both solids and liquids for a minimum of 4 hours
 before cardiac catheterization.

 The investigators explore a fasting protocol that is different from current UHN policy and
 have involved staff from both the cardiothoracic surgery and anesthesiology teams, who will
 also act as a safety monitor and be part of the Data Safety Monitoring Board to ensure that
 participants are safe from harm or adverse effects.

 Currently there is no published data on the association between fasting state and
 peri-procedural vasovagal symptom reduction or procedural satisfaction.

 Hypothesis:

 A more liberal fasting protocol (fasting > 4 hours for solid, but encouraging oral clear
 fluids up to 1 hour prior to the procedure) is associated with a lower incidence of
 peri-procedural vasovagal complications than current standard fasting protocol (> 4 hours for
 both solids and fluids)

 Methods and experimental design:

 This is a prospective single-blind randomized pilot study. The Cardiac Interventionists
 involved in the procedure will be blinded to randomization. All patients undergoing cardiac
 invasive procedures will be screened for eligibility. The participants will be randomised to
 2 groups (eligibility criteria and outcome measures are mentioned in a different section).

 Study Groups Group 1 - Control Group: Participants will be fasted according to current
 standard practice at UHN (a minimum of 4 hours of fasting period for both liquids and solid
 food).

 Group 2 - Intervention group: Participants will be allowed (and encouraged) to drink clear
 fluids up to 1 hour before the procedure. Solid foods will be allowed up to 4 hours before
 the procedure which is current standard practice at UHN.

 Enrolment and randomization:

 Participants who qualify for the study will be approached in person prior to (if in-patient)
 or on the day of the procedure (if ambulatory) to obtain written informed consent prior to
 randomization.

 A verbal explanation and written information in the form of the patient information sheet
 will be given to participants. They will be approached by co-investigators who are not
 involved in their care and given at least 4-24 hours to consent for the study. They will have
 as much time as they need to consider the study. They will also have the opportunity to
 discuss it with their family, friends and family doctor.

 They will be given contact details of the on-site research team including the study doctors
 and nurses who will be able to answer any of their queries at any point during the study.
 They will be notified that they are not obliged to participate in the study and if they do
 decide to take part and change their mind at any point they can withdraw from the study
 unconditionally and their withdrawal will not affect their future care.

 Vulnerable groups will not be participating in this research hence no special measures will
 be taken for their recruitment. Participants will also be informed of any potential safety
 concern that may arise during the study and will be advised about further treatment options.
 Wherever possible the Hospitals translation service will be used to offer translation of the
 consent form to patients who do not have English as their first language. Other individuals,
 who require specialist communication such as the visually impaired or those who suffer from
 deafness will wherever possible, be accommodated with the hospitals on-site services.

 Throughout the study the participant's identity will be protected and will not be disclosed
 outside the Hospital in keeping with the University Hospital Network (UHN) Patient Health
 Information (PHI) policy. At the beginning of the study the investigators will receive an
 identification log to enable them to record patient study pseudonymised identification
 numbers. This record will remain at the central research offices at the participating centers
 and will act as a reference document for the PI. Data from the case report forms (CRFs) will
 be stored on an onsite computer. The hard copy CRFs will be kept in the research doctor's
 office -the persons able to access the case report forms will be the PI and the cardiology
 research doctors and nurses delegated for this study purpose.

 Follow up:

 Participants will be requested to return for one blood test between day 3 and day 5 post-
 procedure. To and from public transport cost will be provided to the patient and one
 accompanying person if needed. A telephonic follow up will also be undertaken at one week to
 ensure no adverse events have occurred.

 Baseline investigations/Information:

 At the time of the procedure , the investigators will obtain and record the following:

 Pre-procedural Information

 1. Pre-procedure investigations (Hemoglobin, Urea, Creatinine, eGFR)

 2. Patient demographics (Diabetes Mellitus {DM}, hypertension {HTN}, renal impairment,
 peripheral vascular disease {PVD})

 3. Index admission diagnosis (NSTEMI, Chronic stable angina)

 4. Weight, height and Body Mass Index (BMI)

 5. Medications on admission

 Procedural and post-procedural information will be recorded, including:

 1. Type of procedure

 2. Route (access site-femoral or radial) of procedure

 3. Intra-procedural details (sedation, analgesia, complications, devices-used)

 4. Procedural and post-procedural outcomes(Success, in-hospital complications, discharge
 time and date, complications including mortality and aspiration pneumonia)

 5. Patient satisfaction survey

 6. Post-procedural creatinine

 7. Post-procedural telephonic call one week from date of procedure Statistical analysis
 Demographic and procedural variables will be presented as percentage (categorical
 variable) or mean ± SD (continuous variable). Comparison of demographic and procedural
 variables between the two groups will be performed by chi-square or Fisher's exact test
 for categorical variables and student's t test for continuous variables. Statistical
 analysis will be performed using SPSS version 22. Randomization will be performed by
 systematic random sampling by utilizing an online computer generated random number
 assignment tool.

 Sample size calculation:

 Sample size was calculated based on proportion and effect size. A total sample size of 240
 patients (120 patients in each arm) would have an 80 % power to detect a 1.0% incidence of
 vasovagal reaction in the intervention arm (for an α of 0.05).

 Funding:

 This study is being funded by the UHN Innovation Committee. Once the outcomes of the pilot
 study are available and if safety endpoints are accomplished, , the investigators will
 consider conducting a similar multicentre study.

 Ethics:

 All aspects of Good Clinical Practice will be adhered to. Patient confidentiality will be
 maintained as per the data protection policy including anonymising data. Ethical approval has
 been obtained from the REB through routine channels (CAPCR).
Inclusion Criteria:

 1. Ability to give written informed consent

 2. Diagnostic coronary angiography and coronary interventions (both elective and stable
 Acute Coronary Syndrome {ACS} patients).

 3. ≥ 18 years of age

 Exclusion Criteria:

 1. Patients who are intubated

 2. Patients unable to give informed consent

 3. Patients presenting with an acute unstable condition, including:

 1. STEMI

 2. unstable ACS

 4. Patients with a history of or at risk for aspiration pneumonia

 -  stroke

 -  dysphagia

 -  severe gastroesophageal reflux disease

 5. Patients with known or anticipated difficult airway

 6. Patients who request to be allotted to a particular arm of the study

 7. Patients who are temporary transfers from other hospitals