Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization (CALORI (NPO))

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Heart Diseases

Treatments: Procedure: Right heart catheterization; Procedure: Coronary angiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT05851872

HM20025962

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 participants in 2 patient groups

Fasting group

Active Comparator group

Description:

Participant will be asked to fast at least 6 hours prior to the procedure

Treatment:

Procedure: Right heart catheterization

Procedure: Coronary angiogram

Non-Fasting group

Experimental group

Description:

Participants will be allowed to eat and drink up to 1 hour prior to the procedure.

Treatment:

Procedure: Right heart catheterization

Procedure: Coronary angiogram