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Fasting or Non Fasting for Cardiac Catheterization

Fasting Versus Non-fasting Prior To Elective Cardiac Catheterization

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03555500
Acronym
FANPRECC
Enrollment
350
Registered
2018-06-13
Start date
2017-11-02
Completion date
2019-03-10
Last updated
2018-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Catheterization, Fasting

Keywords

Fasting, Non fasting, Cardiac catheterization

Brief summary

The current practice of fasting before cardiac catheterization is not based on any studies. If the procedure is to be delayed ( which is common due to busy catheterization lab), this could result in patient's dis-satisfaction and hypoglycemia. Occasionally, cancellation occur because patients are found to be non fasting ( not following the current protocol). The old data of fasting was extrapolated from procedure done under general anesthesia. Now days, cardiac catheterization is always done under local anesthesia and mild sedation. As a matter of fact, emergency cardiac catheterization done for heart attack patients carries more risk than elective one , and are still done without fasting with no reported complication rate like lung aspiration . The highest level of evidence to change the current practice comes from randomized control study. This study has been designed to challenge the current practice. The patients will be divided into 2 groups: * Fasting group (current practice): Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure. * Non Fasting Group: clear fluids and food and up to the time of the procedure The investigators' aim is to show that there is no difference with regards to potential complications between fasting (current practice) and non fasting (new practice) groups of patients with less incidence of hypoglycemia and hypotension in non fasting group. In addition, The investigators believe that patient satisfaction will be improved if patients are allowed to eat freely before the procedure and the catheter lab working ability will be maximized as the list can be filled promptly with patient on the waiting list (as fasting is no longer required) if a previously booked patient has to be cancelled in the last minute improving patient experience along with the associated financial benefits.

Detailed description

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. Finally once the patient is ready for discharge they will be asked to complete an anonymous questionnaire relating to their experience and satisfaction.All patients will be contacted by phone on day 30 or the nearest working day thereafter to ensure no chest infections

Interventions

Non fasting group is allowed for clear fluids and food up to the time of the procedure.

Sponsors

Blackpool Victoria Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients \>18 years undergoing elective coronary angiography or angioplasty procedures

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)

Design outcomes

Primary

MeasureTime frameDescription
Composite incidence of nausea, vomiting, abdominal pain, emergency intubation and aspiration8 hoursThe incidence of any of nausea, vomiting, abdominal pain aspiration or emergency intubation during the procedure and up to 8 hours will be recorded.

Secondary

MeasureTime frameDescription
Incidence of hypoglycaemia1 hourDrop of Blood sugar \< 3.6 mmol/l as assessed by finger prick test before the procedure.
Incidence of hypotension1 hourDrop of SBP\<90 mmHg and /or DBP\<60 mmHg as measured by manual sphygmomanometer before the procedure.
Patient satisfaction1 hourA questionnaire given to the patient after the procedure to assess their experience , symptoms and overall satisfaction with regard to the procedure. The questionnaire include a preset of yes/no question including feeling hungry, thirsty or lethargic before the procedure, feeling headache, nausea or vomited during or up to 1 hour after the procedure. then a final overall satisfaction score about the procedure today from 1- 5, with 1 being not satisfied and 5 being extremely satisfied.
chest infectionAt 30 daysAll patients will be contacted or reviewed in clinic to assess for chest infection

Countries

United Kingdom

Contacts

Primary ContactHesham Abdelaziz, Ph.D
hesham.abdelaziz@bfwhospitals.nhs.uk+44(0) 1253957790
Backup ContactJonas Eichhofer, Ph.D
jonas.eichhofer@bfwhospitals.nhs.uk+44(0)1253957791

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026