Benefits of no Fasting Compared to Fasting Prior to Elective Cardiac Catheterization: A Single-center Randomized-controlled Trial (FAST CATH)

Munson Medical Center

Status: Not yet enrolling

Conditions: Cardiac Catheterization; Coronary Artery Disease; Cardiac Diseases

Treatments: Procedure: Pre-operative instructions to eat and drink at liberty

Study type: Interventional

Funder types: Other

Identifiers

NCT07150780

MHCIIR001-2025

Details and patient eligibility

About

More than one million cardiac catheterizations (CCs) are performed annually in the United States and the majority are elective. Current guidelines recommend no fasting prior to elective CC, however recent studies suggest that eating and drinking as desired prior to elective CCs involving moderate sedation is safe.

This project will study the potential benefits of allowing patients to eat before elective CCs. Participants will be randomly divided into two groups. One group will receive pre-op instructions to fast, and the other group will be allowed to eat and drink as desired prior to their CC. Researchers will compare these groups with regards to patient satisfaction and respiratory complications.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to comply with all study procedures and remain in contact with the study team to complete study assessments for the duration of the study
• Scheduled for an elective (non-urgent) cardiac catheterization
• Age of 18 or older at the time of consent

Exclusion criteria

• Adults unable to consent
• Pregnant women
• Incarceration
• Non-English-speaking patients
• Inability to eat by mouth
• Patients requiring general anesthesia for cardiac catheterization
• Inability to fast for at least 6 hours
• Personal history of pulmonary aspiration, or other known cardiopulmonary anesthetic complication(s)
• Urgent cardiac catheterization
• Inability or unwillingness to comply with all study procedures
• Previously enrolled in this study (patients may not be enrolled more than once for subsequent procedures)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Fasting

No Intervention group

Description:

Prior to the subjects elective cardiac catheterization, they will be instructed to fast for 6 hours with the allowance of clear liquids up to 2 hours.

Non-fasting

Experimental group

Description:

Subjects will be instructed to continue to eat and drink according to their normal diet without restriction, prior to their cardiac catheterization.

Treatment:

Procedure: Pre-operative instructions to eat and drink at liberty