Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
420 participants
INTERVENTIONAL
2022-03-31
2023-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Consented patients will be randomised in a 1:1 ratio to either fasting (standard hospital fasting policy) or non-fasting (allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory).
Primary End Point will composite peri-procedural nausea, vomiting, pre-procedural hypotension, pre-procedural hypoglycemia, intra-procedural emergency endotracheal intubation and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Secondary end-points will include patient satisfaction questionnaire and the individual outcomes assessed in the primary end point.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There was no evidence that the volume or pH of participants' gastric contents differ significantly between fasting and non-fasting populations, as shown by Brady et al. In addition, the overall incidence of nausea and vomiting was reported to be 1% before elective cerebral angiography in a study carried out by Kwon et al. with no significant difference between fasting and non-fasting groups.
A recently conducted a retrospective analysis of registry data for 1916 percutaneous coronary intervention (PCI) patients over a 3-year period. None of the patients was kept nil by mouth (NBM) pre-procedure, and no patients required immediate endotracheal intubation, nor did any develop aspiration pneumonia intra or post procedurally. Thus, they concluded in their observational study that patients undergoing PCI do not need to have fasted before 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. Many patients undergo prolonged periods of fasting before a procedure. While 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.
Further consideration has to be that of patient flow through the cardiac unit. If patients have to be NBM for a certain period before cardiac catheterization, then it reduces the ability to fill lists at short notice if patients need to be cancelled. On the other hand, if the investigators can demonstrate that this period of NBM is unnecessary, the investigators could maximize the catheter lab work as a resource.
Finally, and probably most importantly, the investigators 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.
Our pilot study of 50 patients (25 patients in each group) showed that non-fasting before cardiac catheterization is a safe and feasible approach that carries no additional risk compared to the standard practice of fasting. There was no difference in the primary composite endpoint for safety between the fasting and non-fasting group (one patient in the fasting group developed nausea/vomiting during the procedure and none in the non-fasting group; 4% vs 0, p=0.31). Compared to the fasting group, the non-fasting group had more diabetic patients (4% vs 24%, p=0.009), higher admission blood sugar (7±3 mmol/L vs 5±1 mmol/L, p=0.01), and shorter duration between the last meal and the procedure (110±85 min vs 433±158, p=009). There was no statistically significant difference between the two groups regarding the patient questionnaire results, patient satisfaction score, incidence of hypotension or chest infection within 30 days.
In summary, though growing observational evidence suggests no benefit to fasting, there is no conclusive evidence derived from a robustly randomised controlled trial to support or oppose the continued use of pre-procedural fasting before cardiac catheterisation. This proposed trial aims to add to this body of evidence and clarify guidelines and recommendations pertaining to fasting.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-Fasting
Oral fluids and food up to the time of the procedure.
Advice on fasting before the procedure
Patients are allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory.
Fasting
Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure - current practice.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Advice on fasting before the procedure
Patients are allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Emergency primary percutaneous coronary intervention.
* Vulnerable groups (children under 18 years old, pregnancy, mental health problems that render them unable to give informed consent).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Blackpool Victoria Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hesham Abdelaziz
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hesham K Abdelaziz, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Lancashire Cardiac Centre, Blackpool Victoria Hospital, Blackpool, United Kingdom
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Godwin SA, Burton JH, Gerardo CJ, Hatten BW, Mace SE, Silvers SM, Fesmire FM; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2014 Feb;63(2):247-58.e18. doi: 10.1016/j.annemergmed.2013.10.015.
Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.
Kwon OK, Oh CW, Park H, Bang JS, Bae HJ, Han MK, Park SH, Han MH, Kang HS, Park SK, Whang G, Kim BC, Jin SC. Is fasting necessary for elective cerebral angiography? AJNR Am J Neuroradiol. 2011 May;32(5):908-10. doi: 10.3174/ajnr.A2408. Epub 2011 Mar 17.
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 Apr;100(8):658-61. doi: 10.1136/heartjnl-2013-305289. Epub 2014 Feb 12.
Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
Naidu SS, Abbott JD, Bagai J, Blankenship J, Garcia S, Iqbal SN, Kaul P, Khuddus MA, Kirkwood L, Manoukian SV, Patel MR, Skelding K, Slotwiner D, Swaminathan RV, Welt FG, Kolansky DM. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):255-276. doi: 10.1002/ccd.29744. Epub 2021 May 19.
Related Links
Access external resources that provide additional context or updates about the study.
Association of Anaesthetists of Great Britain and Ireland. AAGBI Safety Guideline 2010.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
303042
Identifier Type: -
Identifier Source: org_study_id