Fasting or non-fasting before cardiac catheterization 1.3

  • Research type

    Research Study

  • Full title

    Fasting or non-fasting before cardiac catheterization

  • IRAS ID

    303042

  • Contact name

    Hesham Abdelaziz

  • Contact email

    hesham.abdelaziz@nhs.net

  • Sponsor organisation

    Research and Development

  • Clinicaltrials.gov Identifier

    NCT05133206

  • Duration of Study in the UK

    1 years, 6 months, 1 days

  • Research summary

    To show that there is no increased risk of complications around the time of the procedure and there is improved patient satisfaction and safety with fewer events of the dangerously low sugar level and too low or too high blood pressure among patients allowed to eat up to the point of the cardiac procedure compared to patients kept nil by mouth. We aim to change the practice of fasting for all patients before catheterization procedures. Consented patients will be selected with equal chances of being advised either to fast (standard hospital fasting policy) or not to fast (i.e. allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory). It is a single-centre study based at Blackpool Victoria Hospital in Blackpool. The endpoint of primary interest is an incidence of feeling sick, vomiting, too low blood pressure, too low sugar level, the tube put down the windpipe to support breathing and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Also, we are interested to find out more about patient satisfaction.
    Eligible are all adult patients undergoing coronary angiography or angioplasty procedures which are elective cases, or admitted with unstable angina/non-ST-elevation myocardial infarction (NSTEMI). Excluded are: patients undergoing other cardiac procedures simultaneously, such as electrophysiology studies, pacing and structural heart disease intervention, emergency primary percutaneous coronary intervention for ST-elevation myocardial infarction (STEMI), and vulnerable groups (children/adolescents under 18 years old, pregnancy, mental health problems that render patients unable to give informed consent). The study is expected to last 18 months and include 420 patients.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    22/NW/0049

  • Date of REC Opinion

    7 Mar 2022

  • REC opinion

    Favourable Opinion