Fasting or Non-fasting Before Cardiac Catheterization (FORCE)

December 4, 2021 updated by: Hesham Abdelaziz, Blackpool Victoria Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Nil by mouth (NBM) has been the standard of care for cardiac catheterization since its inception. The associated vomiting was common with the first generation of radiocontrast materials that were almost toxic, and with the use of general anaesthesia. Induction of anaesthesia depresses the cough and swallow reflex, thus increasing the risk of aspiration. This is also true for deep sedation. However, the practice has largely changed nowadays, with cardiac catheterization procedures being done under local anaesthesia with anxiolytic sedatives often used peri-procedurally to achieve minimal sedation whereby verbal contact is maintained. Both the Royal College of Anaesthetists and the Royal College of Emergency Medicine state that fasting is not required for minimal or conscious sedation but does recommend fasting for general anaesthesia. There is only less than a 1% risk of needing emergency surgery for percutaneous coronary interventions (PCIs). The risk of developing pulmonary aspiration following emergency coronary artery bypass grafting (CABG) surgery or emergency direct current conversion (DC) in patients without pre-procedural fasting is in the order of 0.001%.

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.

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients >18 years undergoing elective coronary angiography or angioplasty procedures in the 2 months window from consent.

Exclusion Criteria:

  • Patients undergoing other cardiac procedures simultaneously such as EP studies, pacing and structural heart disease intervention.
  • Emergency primary percutaneous coronary intervention.
  • Vulnerable groups (children under 18 years old, pregnancy, mental health problems that render them unable to give informed consent).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Fasting
Oral fluids and food up to the time of the procedure.
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.
No Intervention: Fasting
Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure - current practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea.
Time Frame: Within 4 hours after the procedure.
incidence of self-reported nausea measured on a binary scale (yes or no)
Within 4 hours after the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of vomiting.
Time Frame: Within 4 hours after the procedure.
Incidence of vomiting assessed on binary scale (yes or no).
Within 4 hours after the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of pre-procedural hypotension.
Time Frame: Within 2 hours before the procedure.
Pre-procedural hypotension (systolic blood pressure <90 mmHg and /or diastolic blood pressure < 60 mmHg as measured non-invasively by sphygmomanometer)
Within 2 hours before the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence pre-procedural hypoglycemia.
Time Frame: Within 2 hours before the procedure.
Incidence of hypoglycemia peri-procedure (blood sugar < 3.6 mmol/l) as assessed by finger prick test.
Within 2 hours before the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of emergency endotracheal intubation.
Time Frame: During the procedure
Incidence of emergency tracheal intubation for respiratory failure
During the procedure
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of aspiration pneumonia.
Time Frame: During the procedure
Clinically and radiologically(X-ray and /or CT-scan) confirmed aspiration pneumonia.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction assessed by questionnaire using a binary score (YES or NO), qualitative assessment of free text comments and presence of other symptoms as listed in the Description
Time Frame: Within 4 hours after the procedure
Questionnaire assessing the self-reported pre-procedural hunger, thirst/dry mouth, headache, weakness/lethargy, heartburn, dizziness, low mood/anxiety, ability to focus/stay mentally sharp and preferences regarding fasting on a binary scale (yes or no).
Within 4 hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blackpool Victoria Hospital

Investigators

  • Principal Investigator: Hesham K Abdelaziz, MSc, PhD, Lancashire Cardiac Centre, Blackpool Victoria Hospital, Blackpool, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

November 13, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 4, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 303042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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