Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization

Moderate sedation is used in the catheterization laboratory relieve the anxiety and discomfort associated with access and other aspects of the procedure. Whether being in a fasting state (nothing per os, NPO) at the time of the procedure is beneficial or harmful is not well known, but patients are typically required to be fasting at the time of elective procedures, guidance derived from procedures that require general anesthesia. Whereas the typical thinking was that fasting prior to procedures would minimize the risk of aspiration in the event of intubation, or nausea and other symptoms generally, several studies have shown that prolonged fasting prior to procedures is associated with increased nausea, vomiting, aspiration and procedure recovery time.

We aim to evaluate patient satisfaction, nausea and immediate outcomes of patients who are not kept NPO prior to cardiac catheterization.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>18 years of age
Requiring a cardiac catheterization as per standard of care
Elective procedure with planned moderate sedation

Exclusion criteria

BMI >45
All emergent procedures
All mechanical circulatory support-assisted procedures
Other high risk procedures (as identified by the operator)
Pregnant women
Hemodynamically unstable patients
Active GI illness, including nausea at the time of screening
Taking chronic pain medications at home or on current brief course of narcotics
Dementia
Encephalopathy
Patients scheduled for deep sedation
Severe GERD (if the patient requires more than one medication for adequate control of GERD symptoms or has required medical intervention within the past year)

Treatment and study plan

Coronary angiogram

Procedure

Being done per standard of care

Right heart catheterization

Procedure

Being done per standard of care

Primary outcomes

Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)

Time frame: Baseline (Prior to procedure)

We get a wellness score prior to the procedure (right before the patient is taken into the lab) and is on a 0-5 scale with 0 being very happy and 5 being very unhappy.
Intra- and post-procedural vomiting, aspiration, and intubation checklist

Time frame: Within 24 hours after the procedure

We review the chart and ask the participant if they had any vomiting. We also review the chart to see if there are any reports/concern of aspiration and follow up on any chest X-rays that were obtained.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

A Randomized Trial of Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization

Acronym: CALORI (NPO)

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: May 10, 2023
Registry last updated: May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed