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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Diseases

Intervention / Treatment
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* Procedure: Coronary angiogram
* Procedure: Right heart catheterization


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fasting group<br>Participant will be asked to fast at least 6 hours prior to the procedure | Procedure: Coronary angiogram<br>* Being done per standard of care<br>Procedure: Right heart catheterization<br>* Being done per standard of care<br>|
| Experimental: Non-Fasting group<br>Participants will be allowed to eat and drink up to 1 hour prior to the procedure. | Procedure: Coronary angiogram<br>* Being done per standard of care<br>Procedure: Right heart catheterization<br>* Being done per standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-procedure wellness score (hunger, tiredness, anxiety, nausea) | 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. | Baseline (Prior to procedure) | 
| Intra- and post-procedural vomiting, aspiration, and intubation checklist | 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. | Within 24 hours after the procedure |