Fasting Clinical Trial
Official title:
Fasting Versus Non-fasting Prior To Elective Cardiac Catheterization
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.
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
;
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