Fasting Versus Non-fasting Prior To Elective Cardiac Catheterization
Phase: NA
Conditions: Fasting, Cardiac Catheterization
Sponsor: Blackpool Victoria Hospital

 
Page 1 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
Fasting Versus Non-fasting prior to elective Cardiac 
catheterisation 
 
Chief Investigator: 
Dr Jonas Eichhofer 
Principal 
Investigator: 
Dr Hesham Abdelaziz 
 
Research Trust: 
Blackpool Teaching Hospitals NHS Foundation Trust 
 
 
Funder: 
Blackpool Teaching Hospitals NHS Foundation Trust 
 
 
Sponsor: 
Blackpool Teaching Hospitals NHS Foundation Trust 
 
 
Date of Submission: 
 12/10/2017 
 
 

 
 
Page 2 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
 
Table of Contents 
1 
STUDY SUMMARY .......................................................................................................................................... 4 
2 
INTRODUCTION .............................................................................................................................................. 6 
2.1 
BACKGROUND .................................................................................................................................................. 6 
2.2 
STUDY OBJECTIVES .......................................................................................................................................... 8 
3 
STUDY DESIGN ................................................................................................................................................ 9 
3.1  GENERAL ......................................................................................................................................................... 9 
3.2 
STUDY PROCEDURE .......................................................................................................................................... 9 
3.3 
PRIMARY STUDY ENDPOINTS ......................................................................................................................... 10 
3.4 
SECONDARY STUDY ENDPOINTS .................................................................................................................... 10 
3.5 
END OF STUDY ............................................................................................................................................... 10 
4 
METHODS ....................................................................................................................................................... 10 
4.1 
SUBJECT SELECTION AND WITHDRAWAL ....................................................................................................... 10 
4.1.1 
Inclusion Criteria ................................................................................................................................. 11 
4.1.2 
Exclusion Criteria ................................................................................................................................ 11 
4.2 
SUBJECT RECRUITMENT AND SCREENING ...................................................................................................... 11 
4.3 
RANDOMISATION PROCESS ............................................................................................................................ 11 
4.4 
INFORMED CONSENT ...................................................................................................................................... 12 
4.5 
WITHDRAWAL OF SUBJECTS .......................................................................................................................... 12 
5 
PRIOR AND CONCOMITANT THERAPY ................................................................................................. 12 
6 
CLINICAL PROCEDURES ........................................................................................................................... 12 
7 
STATISTICAL PLAN ..................................................................................................................................... 12 
7.1 
SAMPLE SIZE DETERMINATION ...................................................................................................................... 13 
7.2 
STATISTICAL METHODS ................................................................................................................................. 13 
7.3 
INTERIM ANALYSES ....................................................................................................................................... 13 
7.4 
SUBJECT POPULATION(S) FOR ANALYSIS ....................................................................................................... 13 
8 
SAFETY AND ADVERSE EVENTS ............................................................................................................. 13 
8.1 
RECORDING OF ADVERSE EVENTS ................................................................................................................. 14 
8.2 
EXPECTED NON-SERIOUS ADVERSE EVENTS ................................................................................................... 14 
8.3 
SERIOUS ADVERSE EVENTS (SAES) ................................................................................................................ 14 

 
 
Page 3 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
8.4 
EXPECTED SERIOUS ADVERSE EVENTS .......................................................................................................... 15 
8.5 
UNEXPECTED AND FATAL SERIOUS ADVERSE EVENTS ................................................................................... 15 
8.6 
PERIOD FOR RECORDING SERIOUS ADVERSE EVENTS..................................................................................... 15 
9 
DATA HANDLING AND RECORD KEEPING .......................................................................................... 16 
9.1 
CONFIDENTIALITY ..................................................................................................................................... 16 
9.2 
CASE REPORT FORMS ................................................................................................................................ 16 
9.3 
RECORDS RETENTION ................................................................................................................................ 16 
10 
STUDY MONITORING, AUDITING, AND INSPECTING ....................................................................... 17 
11 
ETHICAL CONSIDERATIONS .................................................................................................................... 17 
11.1 
PATIENT INFORMATION SHEETS ................................................................................................................ 18 
12 
FUNDING ......................................................................................................................................................... 18 
13 
SPONSORSHIP ............................................................................................................................................... 18 
14 
PUBLICATION PLAN .................................................................................................................................... 18 
15 
REFERENCES ................................................................................................................................................. 19 
 
 

 
 
Page 4 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
1 
Study Summary 
Title 
Fasting Versus Non-fasting prior to elective Cardiac catheterization 
 
Short Title 
Fasting or no fasting before cardiac catheterization 
Version & Date 
Version 1.7   12 October 2017 
Principal 
Investigator 
Dr Hesham Abdelaziz 
Objectives 
To show that there is no increased risk of peri-procedural complications 
between fasting and non-fasting patients as well as improved patient 
satisfaction when allowed to eat up to the point of elective  coronary 
angiography/angioplasty compared to patients kept nil by mouth. We aim to 
Methodology 
/ 
Design 
 Prospective single centre, single blinded (investigator) randomized Study 
Consented patients will be randomised in 1:1 ratio to either standard hospital 
fasting policy or allowed to eat freely up to the point of transfer to the Catheter 
Laboratory. 
Duration 
 12 months 
Participating 
Centres 
Blackpool Victoria Hospital 
Primary 
End 
Point 
Composite of nausea, vomiting, abdominal pain, emergency endotracheal 
intubation and aspiration, 
Number 
of 
participants 
400 patients  
Main 
Inclusion 
/Exclusion 
Criteria 
INCLUSION 

 
 
Page 5 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
1. All patients >18 years undergoing elective coronary angiography or 
angioplasty procedures in the 2 months window. 
EXCLUSION 
1. Patient choice 
2. Other cardiac procedures such as EP studies, pacing, structural heart 
disease intervention  
3. Emergency PPCI  
4. Patients already admitted in the hospital with UA / NSTEMI 
5. Patients unable to give informed consent 
 
Statistical 
Methodology and 
Analysis 
Our composite primary endpoint will be analysed using 95% confidence 
interval between the fasting and non-fasting group using the Fisher’s exact 
test. Categorical secondary outcomes will be presented as number and 
percentages and compared between the two groups using the Chi-square test 
or Fisher’s exact test. Secondary continuous outcomes will be presented as 
mean and standard deviation and compared using the independent samples t-
test. P-values will be used to assess evidence of difference. P value <0.05 will 
be considered significant. 
 
 
 
 
 
 

 
 
Page 6 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
2 
Introduction 
This document is a research protocol and this study will be conducted in compliance with the 
protocol, The Research Governance Framework, International Conference on Harmonisation, 
Good Clinical Practice Guideline ICH/GCP, and all applicable Blackpool Teaching Hospitals NHS 
Foundation Trust Research Office requirements. 
This study aims to demonstrate that pre procedural fasting for elective cardiac procedures is 
unnecessary and outdated practice.  It is without doubt that induction of general anaesthesia 
depresses cough and swallow reflexes and therefore increases the risk of aspiration with airway 
manipulation.  However, coronary angiography and angioplasty does not require general 
anaesthesia and is carried out purely under local anaesthetic.  So why do we still need periods of 
fasting? 
2.1 Background 
Nil by mouth (NBM) has been the standard of care for cardiac catheterization since its inception, 
because of the associated vomiting that was common with the first generation of radio contrast 
materials that were almost toxic and use of general anaesthesia. Induction of anaesthesia depresses 
the cough and swallow reflex thus increasing the risk of aspiration, this is also true for deep 
sedation.   
 
Today, the cardiac catheterization procedure is done under local anaesthesia with anxiolytic 
sedatives often used peri-procedurally to achieve minimal sedation whereby verbal contact is 
maintained. Both the royal college of anaesthetists and the royal college of emergency medicine 
state that fasting is not required for minimal or conscious sedation but does recommend fasting for 
general anaesthesia.1,2 There is only 1% risk of needing emergency surgery for percutaneous 
coronary interventions (PCIs). The risk of developing pulmonary aspiration following emergency 
coronary artery bypass grafting (CABG) surgery or emergency direct current conversion (DC) in 
patients without pre-procedural fasting is in the order of 0.001%.3 
There was no evidence that the volume or pH of participants' gastric contents differ significantly 
between fasting and non-fasting population as shown by Brady et al.4 In addition, the overall 

 
 
Page 7 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
incidence of nausea and vomiting was reported to be 1% before elective cerebral angiography in a 
study carried out by Kwon et al5 with no significant difference between fasting and non-fasting 
group.  
 
Hamid et al6 recently conducted a retrospective analysis of registry data for 1916 percutaneous 
coronary intervention (PCI) patients over a 3 years period.  None of the patients were kept nil by 
mouth (NBM) pre-procedure and no patients required immediate endotracheal intubation nor did 
any develop aspiration pneumonia intra or post procedurally.  They concluded in their 
observational study that patients undergoing PCI do not need to be fasted prior to their procedures. 
 
The American Society of Anaesthesia guidelines discuss this extensively and have concluded that 
there is no strong relation between fasting, gastric volume, or risk of aspiration. In any case, the 
patients at highest risk for nausea and vomiting are those who present with ST-elevation 
myocardial infarction (STEMI), who are not fasting anyway and the need for emergency 
intubation/CABG remains rare in these patients. 
 
Prolonged unnecessary fasting can often leave patients dissatisfied and add to the discomfort and 
anxiety of waiting for a procedure. Patients may also choose to miss their usual medications on 
the morning of the procedure due to restrictions advised with oral intake, increasing the risk of 
complications such as poorly controlled hypertension and the associated peri-procedural 
complications. 
 
There is also evidence that patients often choose to fast longer than advised by healthcare 
professionals. The reasons for this include: misunderstanding by the patient that a longer period of 
fasting may be more protective, apprehension and loss of appetite before an invasive procedure, 
or practical problems with timing of the procedure. 
 
It is very important to address this fasting issue as many patients undergo prolonged periods of 
fasting prior to a procedure and whilst this is not usually a problem for young fit patients, many of 
the patients do not fall into this category.  Many are elderly with multiple co morbidities and thus 
run the risk of hypoglycaemia and lethargy. 

 
 
Page 8 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
 
A further consideration has to be that of patient flow through the cardiac unit.  If patients have to 
be NBM for a certain period prior to cardiac catheterisation then it reduces the ability to fill lists 
at short notice if patients need to be cancelled.  If we can demonstrate that this period of NBM is 
not necessary then we open the door to maximizing the catheter lab as a resource thus reducing 
length of stay.  This improves patient experience along with the associated financial benefits. 
 
Finally, and probably most importantly we feel that the overall patient experience will be improved 
if patients are allowed to eat up to the point of procedure decreasing the number of hungry, 
disgruntled patients who complain to nurses. 
 
In essence, there is little evidence available about the benefits of pre-procedural fasting and 
prospective randomized trials are lacking with no clear guidelines recommendations that advocate 
the benefit of fasting prior to cardiac catheterization. Therefore, we aim to investigate the safety 
of this approach by this study. 
 
2.2 Study Objectives 
 To show that allowing patients to eat  freely  up to the point of  elective coronary 
angiography/angioplasty is not associated with any increased risk of nausea, vomiting, 
abdominal pain, emergency intubation or aspiration pneumonia compared to patients kept 
nil by mouth.  
 To show improved patient satisfaction when allowed to eat up to the point of elective 
coronary angiography/angioplasty compared to patients kept nil by mouth. 
 
We aim to provide evidence from a prospective study to help the development of guidelines that 
can be implemented nationally and internationally regarding pre procedural care of cardiac 
patients. 
 

 
 
Page 9 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
3 Study Design 
3.1 General 
This will be a prospective single centre, single blinded randomized study.  
3.2 Study procedure 
All patients to be admitted electively for coronary angiography or angioplasty will be given the 
opportunity to participate.  An invitation letter together with patient information leaflet outlining 
the study will be sent along with the pre-procedure appointment letter to give the patient time to 
read and think about the study.  Once at pre-procedure assessment clinic, the study will be 
explained further including potential risks and intended outcome and patients concerns will be 
addressed. Patient will be given the opportunity either to take part in the study or abstain and follow 
the standard procedure.  If the patient agrees then they will sign the consent form and then be 
randomised in a 1:1 ratio to either the fasting or non-fasting group and be allocated a patient 
identification number.  This will be done at the pre-procedure assessment clinic. 
1- Fasting group (current practice):  Clear fluids up to the time of the procedure and no food for 
at least 2 hours before the procedure. 
2-Non Fasting Group: Clear fluids and food up to the time of the procedure. 
 The pre procedure preparation will then be documented in the notes. Intention to treat analysis 
will be used to avoid the effects of crossover and dropout providing unbiased comparisons among 
the treatment groups. 
The case report form (CRF) will be appended inside the front cover of the notes to be completed 
on the day of procedure by the operating physician and the remainder completed by the research 
team.  Finally once the patient is ready for discharge they will be asked to complete an anonymous 
questionnaire relating to their experience and satisfaction. 
A database will be composed on an encrypted flash drive and backed up on the catheter lab 
computer.  Only the patient identification number will be included in this but will still be password 
protected. 

 
 
Page 10 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
All patients will be contacted by phone on day 30 or the nearest working day thereafter to ensure 
no chest infections. 
3.3 Primary Study Endpoints 
Primary endpoint is a composite of nausea, vomiting, abdominal pain, emergency intubation and 
aspiration 
3.4 Secondary Study Endpoints 
 Patient satisfaction 
 Incidence of hypoglycaemia ( blood sugar < 3.6 mmol/l) as assessed by finger prick test 
 Incidence of hypotension ( SBP<90 mmHg and /or DBP<60 mmHg) 
 30 day chest infection rate 
3.5 End of study 
Data collection will start November 2017 and we will continue until the 400 patients are enrolled 
or premature termination of the study due to safety issue. The last phone contact/ clinic visit will 
be done 30 days after the enrolment of the last patient. 
4 
Methods 
4.1 Subject Selection and Withdrawal 
Once enrolled in the study all patients will be identified by their study number alone and the arm 
of the study they are involved in. If the patient decides to withdraw from the study at any point 
after randomization, they will revert to the standard hospital procedure policy of fasting. However, 
they will still be included in the final analysis as intention to treat and any drop out or cross over 
will be documented.   
4.1.1 Inclusion Criteria 
 All patients >18 years undergoing elective coronary angiography or angioplasty procedures 
in the 2 months window. 

 
 
Page 11 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
4.1.2 Exclusion Criteria 
 Patient choice 
 Other cardiac procedures such as EP studies, pacing, structural heart disease intervention  
 Emergency PPCI  
 Patients already admitted in the hospital with UA / NSTEMI 
 Patients unable to give informed consent (vulnerable group) 
4.2 Subject Recruitment and Screening 
All patients undergoing elective cardiac catheterisation procedures will be sent an invitation in the 
post including the patient information leaflet together with their pre-procedure assessment date.  
This will allow them to read about the study prior to the assessment to decide whether they would 
like to be included.  Once at the pre-procedure assessment clinic, the study will be further 
discussed, any questions will be addressed and the consent form will be signed should they wish 
to be included. 
4.3 Randomisation Process 
Randomisation will take place in pre-procedure assessment clinic in a 1:1 ratio using sealed 
enveloped method.  This information (whether fasting or not) will be relayed to the patient at the 
time of pre-procedure assessment and also stored on a spreadsheet with study number the only 
identifying factor.  This will be password protected with individuals directly involved having 
access to this.  This data will also be backed up on a password protected computer in the catheter 
laboratory.   
 
4.4 Informed Consent 
The patient will receive a detailed description of the study in the patient information sheet sent 
together with pre-procedure assessment letter by mail (around 1 week before the pre-procedure 
assessment clinic date). In the pre-procedure assessment clinic, the study will be explained further 
including potential risks and intended outcome, any patient's question will be addressed, with each 

 
 
Page 12 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
patient given the opportunity to abstain and follow standard procedure.  If the patient agrees then 
they will sign the consent form and then be randomised in a 1:1 ratio to either the fasting or non-
fasting group.  This will be attached to the inside cover of the notes and checked on the time of 
presentation on the day of intended procedure. 
4.5 Withdrawal of Subjects 
If any patient chooses to withdraw from the study, they will revert to the standard hospital 
procedure. However, they will still be included in the final analysis as intention to treat and any 
drop out or cross over will be documented.   
5 
Prior and Concomitant Therapy 
All previous medication and treatments should continue. 
6 
Clinical Procedure 
As standard practice, operators will be allowed to use any techniques they commonly use 
throughout their practice (choice of access, balloon and stent type). 
7 
Statistical Plan 
Given that the occurrence of pulmonary aspiration was so low in similar studies performed for 
cerebral angiography, we decided against using this as a single primary endpoint as thousands of 
patients would be required.  We opted for a composite primary end point of nausea, vomiting, 
abdominal pain, emergency intubation and aspiration.  These will be recorded both immediately  
intra/post procedure by the operation physician and again by the patient within 8 hours after the 
procedure.  We will compare the two groups using 95% confidence intervals to ascertain the extent 
to which they overlap.  Secondary end points will be overall patient satisfaction, the incidence of 
hypoglycaemia and hypotension, and 30 day chest infection rate which will be compared between 
the two groups. 

 
 
Page 13 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
7.1 Sample Size Determination 
With 200 participants in each group, if none of the participants has an event then the upper limit 
of the 95% confidence interval for event rate would be 1.5%. Hence if both groups, fasting and 
non-fasting, have no events recorded then it is highly unlikely that the event rate in the two groups 
would differ by more than 1.5%. Provided that a difference of 1.5% in event rate is deemed not 
clinically meaningfully different; then 200 participants in each group would demonstrate that not 
fasting has a similar event rate to fasting.  
7.2 Statistical Methods 
Our composite primary endpoint will be analysed using 95% confidence interval between the 
fasting and non-fasting group and the event rate will be compared using the Fisher’s exact test. 
Categorical secondary outcomes will be presented as number and percentages and compared 
between the two groups using the Chi-square test or Fisher’s exact test. Secondary continuous 
outcomes will be presented as mean and standard deviation and compared using the independent 
samples t-test. P-values will be used to assess evidence of difference. Any P value < 0.05 will be 
considered significant. 
7.3 Interim Analyses 
Final Analysis will take place once all data is collected. However, if sequentially the first 10 
patients in the non-fasting group show signs of an event rate in excess of that shown in the fasting 
group as demonstrated by non-overlapping confidence intervals then stopping rules will be 
applied. For this pilot study, this will be monitored by the Chief Investigator. 
7.4 Subject Population(s) for Analysis 
All participants will be used in analysis. Intention to treat analysis will be used to avoid the effects 
of crossover and dropout providing unbiased comparisons among the treatment groups. 
8 
Safety and Adverse Events 
Any complications will be treated in the usual way irrespective of study arm included in. 

 
 
Page 14 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
 
The Chief Investigator will be continuously monitoring the data and if sequentially the first 4 
(15%) patients in the non-fasting group show signs of an event rate in excess of that shown in the 
fasting group, as demonstrated by non-overlapping confidence intervals then stopping rules will 
be applied.  
8.1 Recording of Adverse Events 
All adverse events occurring during the study period will be recorded.  The clinical course of each 
event will be followed until resolution, stabilisation, or until it has been determined that the study 
treatment or participation is not the cause.  Serious adverse events that are still ongoing at the end 
of the study period will be followed up to determine the final outcome. The cardiac anaesthetic 
team has been made aware of the study in case a non-fasting patient need to be taken for emergency 
surgery. 
8.2 Expected non-serious Adverse Events 
The following are expected non-serious events and will be recorded on the Case Report Form and 
reported to the CI as necessary. They do not need to be reported to the sponsor.  
These include: 
 Nausea and vomiting. 
 Abdominal pain 
 Procedure-related transient bradycardia (HR<60 bpm). 
 Procedure-related transient hypotension (SBP<90 mmHg). 
 Puncture site related hematoma/ecchymosis. 
8.3 Serious Adverse Events (SAEs) 
All SAEs will be recorded on the Case Report Form and reported to the CI within 7 days. The CI 
will be responsible for the prompt notification of findings that could adversely affect the health of 
patients or impact on the conduct of the trial.  Only unexpected SAEs or fatal events will be 

 
 
Page 15 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
reported to the Sponsor immediately (maximum within 15 days). The sponsor will report events 
to the REC as necessary (usually only events that are both related to the intervention and 
unexpected).  
The following information will be collected for each serious adverse event: 
 Whether the event is considered expected or unexpected 
 Full details in medical terms and case description 
 Event duration (start and end dates, if applicable) 
 Action taken 
 Outcome 
 Causality in the opinion of the investigator 
8.4 Expected Serious Adverse Events  
 Emergent CABG. 
 Stroke/TIA. 
 Coronary perforation and cardiac tamponade. 
 Peri-procedural MI related to acute vessel closure (troponin > 300 ng/L). 
 Allergic reactions to the dye or medications used during the procedure. 
 Major vascular complications as acute thrombosis, distal embolization, dissection, major 
bleeding (>2 gm% drop in hemoglobin, requiring blood transfusion, retroperitoneal 
bleeding or resulting in shock).pseudo-aneurysm, or arterio-venous fistula. 
 Infection 
 Cardiac arrest requiring  resuscitation involving ventricular defibrillation/DC shock 
8.5 Unexpected and fatal Serious Adverse Events 
 Emergency endotracheal intubation. 
 Pulmonary aspiration. 
 All other serious adverse events that are not listed under" expected SAEs". 
 Events that results into death. 

 
 
Page 16 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
8.6 Period for recording Serious Adverse Events 
Data on serious adverse events will be collected from the time of procedure for the 1 month follow-
up period. 
9 
Data Handling and Record Keeping 
9.1 Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Data Protection Act and The Research Governance Framework for Health and 
Social Care. 
 Subjects will be identified by Study number alone. 
 All health professionals involved in the study and patient care will have access to this 
information if required. 
 All patient data will be password protected in the computer in the cath lab 
 If a patient needs to be identified for a clinical or safety reason, CI will be consulted. 
The Chief Investigator (CI) is the custodian of the data. 
9.2 Case Report Forms 
The study case report form (CRF) is the primary data collection instrument.  
 All data requested on the CRF/DCF will be recorded. 
 All missing data will be explained.  If a space on the CRF/DCF is left blank because the 
procedure was not done or the question was not asked,  “N/D” will be written. 
 If the item is not applicable to the individual case,  “N/A” will be written. 
 All entries should be printed legibly in black ink. 
 To correct any data entry error, a single straight line will be drawn through the incorrect 
entry and enter the correct data above it.  All such changes will be initialled and dated. 

 
 
Page 17 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
9.3 Records Retention 
All records will be archived for 5 years in line with the Trust R&D Policy. 
10 Study Monitoring, Auditing, and Inspecting 
The investigator will permit study-related monitoring, audits and inspections by the Ethics 
Committee, the Sponsor and the Research Governance Manager. 
Participation as an investigator in this study implies adherence to the principles and responsibilities 
of the Research Governance Framework, ICH/GCP and Directive 2000/20/EC 
11 Ethical Considerations 
The patient will receive a detailed description of the study in the patient information sheet send 
together with pre-procedure assessment letter by mail (around 1 week before the pre-procedure 
assessment clinic date) to give him/her time to think about the study. Then, at the pre-procedure 
assessment clinic, they will have the opportunity to ask questions with one of the research team 
and to answer any queries. Any patient will have the right to abstain from taking part into the study 
or to withdraw after taking part without affecting the standard of care they are receiving. 
 
The Chief Investigator will ensure that the risk of the study does not outweigh the benefit at any 
point during the study time, and if so, the study will be prematurely terminated. 
The benefit /risk of taking part into the study will be adequately explained to the patients. There 
will be no direct benefit to the patient from taking part in this study. However, the information 
gained from the study will help improve the quality of service offered to the patients, increase their 
satisfaction, may aid in changing the current practice and avoiding unnecessary delay to the 
patients. The potential risk will be made clear which is the occurrence of nausea and vomiting at 
an expected rate of 1-2% and no expected emergency endotracheal intubation or aspiration 
pneumonia cases. 
Once patient is enrolled in the study, all his personal information will be anonymized with the only 
identifier the study number. All patient data will be password protected on the computer in the 
cath lab. All health professionals involved in the study and patient care will have access to this 

 
 
Page 18 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
information if required. Only the CI will have access to identify the patient personal data for the 
purpose of safety.  
To ensure un-biased result, an adequate randomization process with intention to treat analysis will 
be undertaken. Analysis will be done by the Sub-Investigator who is blinded to group allocation.  
11.1 Patient information Sheets 
A patient information sheet with a detailed description of the study including the objectives, any 
risk to the patient and what is required from the patient to do if he/she accept to participate as well 
as safety issues and contact number for the research team. This will be distributed before pre-
procedure assessment clinic date. 
12 Funding 
This pilot is supported by Blackpool Teaching Hospitals NHS Foundation Trust and no additional 
funding is required for the first 50 Patients in this Pilot study 
13 Sponsorship 
Blackpool Teaching Hospitals Foundation Trust is acting as sponsor for this pilot study. 
No specific or additional training is required for the research staff in order to take part in the study. 
14 Publication Plan 
Once this Pilot study has finished, we aim to submit the result as an abstract in one of the 
cardiology journals and present it as a poster/ oral presentation in a national/international 
cardiology conference. In addition, there is a plan to carry out a large single/multicentre study to 
prove the result of this pilot study with the aim of large international publication.  
 
 

 
 
Page 19 of 19                     Version 1.7              12 October 2017      IRAS ID( 215149) 
 
15 References 
1. Godwin SA, Burton JH, Gerardo CJ, Hatten BW, Mace SE, Silvers SM, Fesmire FM.  
Clinical policy: Procedural sedation and analgesia in the Emergency Department.  Ann 
Emerg Med.  2014;63:247-58.e18. 
 
2. Association of Anaesthetists of Great Britain and Ireland.  AAGBI Safety Guideline 2010. 
 
3. Rosengarten J, Ozkor M, Knight C. Fasting and cardiac catheterization should we be 
following the evidence. Controversies and Consensus in Imaging and Intervention (C2I2) 
2007;V5:22–3 
 
4. Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative 
complications. Cochrane Database Syst Rev 2003;(4):CD004423. 
 
5. Kwon OK, Oh CW, Park H, Bang JS, Bae HJ, Han MH, Park SH, Han MK, Kang HS, Park 
SK, Whang G, Kim BC, Jin SC.  Is fasting necessary for elective cerebral angiography?  
Am J Neuroradiol 2011;32:908-10. 
 
6. Hamid T, Aleem Q, Lau Y, Singh R, McDonald J, MacDonald JE, Sastry S, Arya S, 
Bainbridge A, Mudawi T, Balachandran K.  Pre-procedural fasting for coronary 
interventions: is it time to change practice?  Heart.  2014;100:658-661