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Fasting or Non-fasting Before Cardiac Catheterization

NCT05133206 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2021-12-14

No results posted yet for this study

Summary

The investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Therefore, the investigators aim to change the practice of fasting for all patients before elective catheterization procedures.

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.

Conditions

Interventions

OTHER

Advice on fasting before the procedure

Patients are allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory.

Sponsors & Collaborators

  • Blackpool Victoria Hospital

    lead OTHER

Principal Investigators

  • Hesham K Abdelaziz, MSc, PhD · Lancashire Cardiac Centre, Blackpool Victoria Hospital, Blackpool, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-08-31
Completion
2023-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133206 on ClinicalTrials.gov