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

Not Applicable

Completed

• Conditions: Heart Diseases
• Interventions: Procedure: Coronary angiogram; Procedure: Right heart catheterization

• Registration Number: NCT05851872
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-10
• Primary Completion: 2023-12-05
• Study Completion: 2023-12-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting group	Coronary angiogram	Participant will be asked to fast at least 6 hours prior to the procedure
Non-Fasting group	Coronary angiogram	Participants will be allowed to eat and drink up to 1 hour prior to the procedure.
Non-Fasting group	Right heart catheterization	Participants will be allowed to eat and drink up to 1 hour prior to the procedure.
Fasting group	Right heart catheterization	Participant will be asked to fast at least 6 hours prior to the procedure

Primary Outcome Measures

Name	Time	Method
Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)	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	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States